Yes, all of our products, the iTotal®, iTotal® Identity, Identity ImprintTM, iUni®, and iDuo® have been cleared by the FDA.

Our implants are made out of cobalt chromium molybdenum, a standard metal used in orthopedic implants. The tibial and patellar inserts are made of ultra high molecular weight polyethylene (UHMWPE) or highly crosslinked vitamin-e infused UHMWPE (iTotal only).

Knee arthroplasty procedures using our implants are fully or partially covered by Medicare and most major insurance companies, under the same insurance reimbursement codes as our competitors’ “off-the-shelf” knee implants. Please consult with a surgeon using restor3d technology to learn more about your specific costs and coverage.

Our pre-navigated implants (Identity ImprintTM) have been designed based on advanced CT scan data from about 85,000 real-world restor3d patients. Approximately half of them are women, so female anatomy is taken into account. For the personalized implant option (iTotal® Identity), as we would design your knee just for you, there are no male versus female considerations. It is simply your knee.

The knee joint is comprised of three bones: the femur (thigh bone), the patella (knee cap), and the tibia (shin bone). It can be divided into the medial compartment, the side of your knee that is closest to the center of your body; the lateral compartment, the side of your knee to the outside of your body; and the patellofemoral compartment, which is the area behind the knee cap.

The end of each of the bones of the knee is covered with a layer of smooth, glossy, elastic tissue known as articular cartilage. Cartilage protects the bones while allowing the joint to glide smoothly. It also acts as a shock absorber. Cartilage has no nerve or blood supply. If damaged or injured, it may be difficult for it to heal or repair itself.

Ligaments of the knee link the bones, while muscles and tendons aid in strength, stability, and movement. Ligaments include the anterior cruciate ligment, commonly called the ACL, the posterior cruciate ligament (the PCL), the medial collateral ligament (MCL) and the lateral collateral ligament (LCL). The health and stability of your ligaments can be important determining factors in whether one surgical option is better for you than another.

On the top of the tibia are two crescent-shaped pieces of cartilage called the inner and outer pads act as weight distributors when we walk, stand and move about. Their specialized shape also helps to keep the knee stable and conforms to the profile of the femur.

Condyles are rounded prominences at the end of a bone, most often important for articulation with another bone. Each person’s condyles have unique shapes and sizes.

A partial knee replacement preserves the part of the knee not damaged by arthritis and the surgeon treats only the affected compartments of the knee.

In a healthy knee, the ends of the thigh bone, the shin bone, and the knee cap are covered by a layer of articular cartilage. This cartilage acts as a cushion and provides a smooth, gliding surface for the movement of the knee.

Through the years, tremendous demands are placed on our knees. In some, the cartilage can begin to fracture or wear away. If the wear becomes significant, the rubbing of exposed bone can result in debilitating pain. This is called osteoarthritis (OA) and it affects millions worldwide.

Osteoarthritis (OA) is considered a progressive disease but the exact causes of are not fully understood. OA is very common in adults over the age of 50, but the condition can affect younger adults as well. People who have a history of past knee injuries, or have placed a lot of stress on their knees from heavy physical activity or weight are also at increased risk.

Symptoms of knee osteoarthritis include:

• Pain during movement

• Tenderness

• Stiffness, usually after periods of inactivity

• Lack of flexibility and an inability to move through the full range of motion

• Grating sensation

• Bone spurs – small, hard lumps felt around the joint

There is no known cure for knee osteoarthritis, but there are a number of other treatment options available that you should discuss with your doctor, including:

• Lifestyle changes, such as weight loss, exercise or physical therapy

• Over-the-counter anti-inflammatory pain medication (NSAIDs)

• Corticosteroids (anti-inflammatory knee injections)

• Viscosupplementation (hyaluronic acid knee injections, or lubricating fluid for your joint)

• Joint replacement surgery, or arthroplasty

The CT scan is a diagnostic tool for your surgeon to assess the course of treatment for your knee. CT scan data is used to create a 3D model of your knee to either design your personalized knee implant system (in approximately 6 weeks) or to select the best fit size of your pre-navigated implant (in approximately 3 weeks). The advanced scan data also drives the creation of your personalized surgical plan and 3D-printed surgical instruments.

It is recommended to book your CT scan appointment as soon as you can. If you elect to receive a personalized knee implant, then your personalized knee implant cannot be designed until your CT scan images are received. If you elect to receive a pre-navigated knee implant, then the selection of your size, your personalized surgical plan, and your personalized, 3D-printed surgical instruments all rely on the CT scan.

Your surgeon will recommend an imaging center that has been qualified to perform CT scans that capture the required images to design your individualized implant.

The CT scan appointment typically takes 45-60 minutes. It is always a good idea to give yourself more time, and to arrive early to ensure your scan can start on time.

If you choose the personalized implant option, from the time restor3d receives the order and your CT scan it takes 6 weeks to develop and deliver your implant to the medical facility in advance of your surgery date.

If you choose the pre-navigated implant option, then the time to select your optimal implant size, 3D-print your surgical instruments, produce a personalized surgical plan, and deliver everything to the medical facility in a sterile Surgery-In-A-Box kit is approximately 3 weeks.

It can be helpful to designate someone as your primary “caregiver.” This person will be there with you on your day of surgery, help carry your belongings and stay in touch with other family or friends during and immediately following your surgery. The primary caregiver may also be helpful following surgery (i.e., driving home, assisting in follow-up doctor visits, physical therapy and completing light chores around the house).

It may also be helpful to complete as many chores and/or errands as possible prior to surgery. Preparing your home by removing tripping hazards such as rugs and moving your living quarters to the ground floor will ensure an easier rehabilitation.

Prior to your day of surgery, be sure to pack a small suitcase with loose fitting comfortable clothing and necessary toiletries. In some cases you may be in the hospital from 1-3 days. Please check with your surgeon on how long you are expected to stay so you can pack accordingly.

Knee surgery has become a very common procedure. A total knee replacement can take 60–90 minutes to complete. Be sure to consult with your knee surgeon about his/her expectations for the surgery.

After you have been admitted and prior to the actual surgery, you will receive an IV (intravenous) line that is used to administer antibiotics and anesthesia. The actual surgery involves a thin incision on the knee that helps the surgeon gain access to the affected compartment(s). Your surgeon will place your personalized surgical instrumentation on your femur (thigh bone) and tibia (shin bone) in order to facilitate the procedure. Your knee implants are then cemented into place and the incision is closed.

Following surgery, you will focus on recovery and rehabilitation. Performing range of motion exercises during physical therapy is especially important to prevent scar tissue from limiting the flexibility of the new joint.

As every case is different, please be sure to follow your surgeon’s recommendations for pain medication and physical therapy.

You should be able to walk, as tolerated, a few hours after surgery. You may be provided with a knee brace and/or aids such as crutches or a walker to assist you.

Your surgeon will determine whether or not you will need to wear a brace. If you do, you will likely wear your brace for two weeks or less depending upon your surgeon’s recommended weight-bearing protocol.

Following surgery you may not have the full leg control required to work the gas and brake pedals. As a safety precaution, your surgeon may recommend that you not drive for a few days.

Your surgeon may prescribe medication to control pain after surgery and/or coated aspirin to prevent blood clots. It is important that you consult with your physician before taking any non-prescribed medications.

Following surgery, it is important to keep your incision covered with a clean dressing. Your surgeon will recommend that you use caution while bathing to keep your incision dry. Waterproof bandages are recommended. Be sure to contact your surgeon if you notice any changes in the incision such as swelling or drainage during the recovery period.

Immediately after your procedure, you may have a low grade fever (up to 101 degrees). It is important to contact your doctor if your temperature elevates above 101 degrees or lasts longer than one week.

Your surgeon can best determine how much physical therapy is appropriate for you. In many cases, physical therapy is prescribed to avoid the build-up of scar tissue, help restore normal movement in your joint, build up strength in the joint and surrounding muscles, ease pain and swelling, and help with circulation. In all cases, an immediate postoperative recovery will focus on protecting the knee, minimizing discomfort, and ensuring an early return to motion. After that, your surgeon will prescribe a set of simple exercises to aid in knee replacement surgery recovery and strengthen your knee.

Total hip joint replacement (or total hip arthroplasty) is a treatment for degenerative arthritis in the hip joint, during which damaged bone and cartilage is removed and replaced with prosthetic components.

Within the hip, the femoral head (ball at the top of the femur, or thigh bone) is connected to the acetabulum or “hip socket” of the pelvis bone. This connection is much like a ball and socket and like all joints, there is a layer of cartilage on the ends of the bones where they make contact. Synovial fluid surrounds the hip joint and acts as a lubricant to reduce friction, allowing the hip to move and swivel smoothly.

When the cartilage that provides padding starts to breaks down, eventually causing direct bone-on-bone contact is when, aches, pains, stiffness, swelling and decreased range of motion and flexibility can occur. This occurrence is called, degenerative arthritis.

Total hip replacement surgery involves the following components:

Cup Liner – A plastic or ceramic spacer is inserted between the new ball and the cup to allow for a smooth gliding surface.

Femoral Stem – Once the damaged femoral head is removed a metal component is placed into the hollow center or canal of the femur (thigh bone). The femoral stem may be either cemented or wedged into the bone creating a “press fit” to hold the prosthesis in place.

Femoral Head (Ball) – A metal or ceramic ball is placed on the upper part of the femoral stem component. This ball replaces the damaged femoral head that was removed.

Acetabular Cup (Socket) – The damaged cartilage surface of the acetabulum (hip socket) is removed and replaced with a metal or polyethylene cup or socket. Screws or cement are sometimes used to hold the cup in place.

In the Partial Hip Replacement surgical procedure, only the femoral head (ball) of the damaged hip joint is replaced with a prosthetic implant. The hip socket is not substituted or replaced allowing the femoral head prosthetic to articulate with the native acetabular anatomy. A partial hip replacement can also be called a hemi-arthroplasty.

Traumatic hip injuries (broken and fractured hips) are the primary reason for partial hip replacement. It is not typically a treatment for degenerative arthritis of the hip joint.

During traditional hip replacement surgery, surgeons typically select standard replacement parts for the femoral stem and acetabular cup from several available sizes. If the standard parts are too big or too small, then surgeons can choose a size up or down as needed, by trial and error, they find the size that fits the   patient’s anatomy most appropriately.

restor3d has designed a 3D (3-dimensional) patient specific hip system to improve upon the traditional surgical process and provide a unique implant for each individual.

The restor3d Hip System is the first ever and only 3D (3-dimensional) designed custom primary total hip replacement system.

The restor3d Hip System uses individualized implants intended to replicate the structure and function of each patient’s natural anatomy. The system reduces estimation during surgery using 3D surgical planning by targeting the precise position for those individualized implants.

With the restor3d Hip System, computed tomography (CT) scans of patients’ hips are converted into 3D virtual computer models, taking into account the unique measurements of their anatomy. Surgeons may then make adjustments and corrections – such as, widening or narrowing the hip, also known as the “offset.”

Once surgeons complete their virtual review, they approve the final individualized implant design. The new personalized design is then sent to restor3d engineers, who create the implant parts out of titanium alloy, along with customized 3D-printed tools and guides for the surgical procedure.

restor3d develops a comprehensive, individualized, pre-operative surgical plan (iView®) that is delivered to the surgeon well in advance of the operation. The iView® shows surgeons the pre-planned positioning of each implant. This allows the surgeons to visualize the placement of the implant within each patient’s actual anatomy in 3D, enabling better positioning of the implant.

Traditional implant systems use a 2D (2-dimensional) templating technique for standard implant size and positioning. 2D templating and standard implant sizes make traditional hip replacement an unguided surgery with some estimation required by surgeons during their surgical planning and procedure. If the prostheses are not properly placed, the length of the leg and/or hip offset could be shortened or lengthened causing the patient’s gait to be compromised and at increased risk for dislocation of the joint.

In contrast, restor3d 3D (3-dimensional) Hip System is designed to address many of the short comings of traditional primary hip replacements today because it is personalized. It is all about the individual:

1. Personalized components are designed in 3D from patients’ computed tomography (CT) scans to replicate the structure and function of each patient’s natural anatomy

2. Surgeons leverage the 3D models to adjust and correct the design of each personalized implant to minimize the risk of leg length and hip offset discrepancies

3. Individualized pre-operative surgical plans enable surgeons to accurately position the hip implants

4. restor3d personalized instruments (iJigs®) enable proper placement and orientation of both the femoral stem and acetabular cup implants

5. A groundbreaking acetabular cup reaming system adds efficiency and accuracy

The restor3d Hip System is the first hip system to provide orthopedic surgeons with guided placement of custom implants, designed to address the wide variations in anatomy presented across patient demographics.

In general, many hip replacement surgeries range from 1-2 hours in length. However, the length of a hip replacement surgery depends on several factors – the surgeon, how complicated the specific case is, the patient’s physical condition and weight, the severity of the patient’s joint osteoarthritis, the type of replacement received, and whether the surgery is a partial (hip hemiarthroplasty) or full hip replacement.

As prescribed by surgeons, physical therapy is an important step to help restore hip joint motion and strength, and to decrease the risk of dislocating new hip replacements. Physical therapy often begins the day after surgery and, within days, patients can typically walk with a walker, crutches, or a cane. Physical therapy usually continues for weeks to months following the surgery. The focus of therapy is often on increasing the range of motion in the new joint as well as strengthening the muscles surrounding the hip. Balance exercises are also commonly performed to help decrease the risk of falling. Patients are advised to speak to their doctor or therapist to identify precautions to minimize the risk of hip dislocation.

Immediately after surgery, scar tissue begins to form. This scar tissue will form not only at the incision site, but also deep within the joint. It is common at this point for patients to still have a feeling of stiffness, particularly if they have stayed in one position for too long. Physical therapists usually prescribe exercises to stretch out scar tissue while it is still pliable, and thereafter patients typically continue to gain motion for up to 12 months.

Hip replacement recovery time varies from person to person. Because individual circumstances, medical conditions, and pain tolerance are different for each patient, there is no definitive timeline for the length of pain after surgery. Everyone is different. Some hip patients report that their arthritis pain is gone immediately after total hip replacement surgery but, even in these instances, it is typically replaced by surgical pain for about 4-6 weeks (1 – 1.5 months), the time at which many patients begin reporting improved pain control.

Hip replacement recovery time varies from person to person. When a surgeon clears hip replacement patients to return to work depends on both the pace of the patients’ individual recoveries and the types of duties required by their jobs. In general, many patients are not advised to return to work until at least 6-8 weeks (1.5 – 2 months) after their hip replacement. However, some surgeons may clear patients to return to work earlier if their job primarily involves sitting.

Hip replacement recovery time varies from person to person. Everyone is different. Many patients can walk with assistance on the same day as surgery, or on the day after surgery. Then, many patients can resume routine activities within 10-12 weeks (2.5 – 3 months) after hip surgery. However, full recovery from a hip replacement typically takes up to 12 months, but this is dependent on each patient’s specific circumstances.