Responsive Orthopedics Total Knee Arthroplasty System

The Responsive Orthopedics Total Knee Arthroplasty System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

• Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis
• Inflammatory degenerative joint disease including rheumatoid arthritis
• Correction of functional deformity
• Revision procedures where other treatments or devices have failed
• Treatment of fractures that are unmanageable using other techniques

The Responsive Orthopedics Total Knee Arthroplasty System is indicated for cemented use in cases of osteoarthritis and rheumatoid arthritis

View full instructions for use

CONTRAINDICATIONS

Contraindications include but are not limited to:

1. Overt or suspected latent infection of the knee joint
2. Active infections at other sites that may spread to the knee joint. Should a patient have any infection prior to implantation, the foci of that infection must be treated prior to, during, or after implantation
3. Patients with inadequate musculature or neuromuscular disorders leading to loss of function in the limb or possibly leading to complications in post-operative care
4. Patients with poor bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and fixation of the device
5. Severe ligamentous or muscle laxity, or inadequate soft tissue coverage to allow for normal healing and re-establishment of proper mechanics

POTENTIAL ADVERSE EVENTS

1. Osteolysis
2. Change in positioning, loosening, bending, cracking, fracture, deformation or wear of one or more of the components
3. Pain, dislocation, subluxation, decreased range of motion, or shortening or lengthening of the leg due to improper positioning, looseness, or wear of components
4. Femoral, tibial, or patellar bone fracture intraoperatively, or postoperatively due to trauma, excessive loading or poor bone stock
5. Allergic reactions to materials of components
6. Superficial or deep infection, which may delay healing and necessitate the removal of the prosthesis
7. On rare occasions, arthrodesis of the joint or amputation of the limb may be necessary
8. Nerve damage, deep vein thrombosis, periarticular calcification or ossification, articular injury, or vascular occlusion

WARNINGS

• Never combine components with those made by different manufacturers.
• Do not implant any device that has been used, or if the package appears damaged, tampered with or breached.

PRECAUTIONS

• Surgeons should be familiar with the implant, instruments, and surgical technique before implanting this device.
• Surgeons should consider the following factors which could lead to an increased rate of failure: excessive patient weight, high levels of patient activity, or poor bone stock.
• The surgeon and O.R. staff should be careful not to damage or alter the components in any way, especially polished contact surfaces.
• Instruments are provided non-sterile. The user facility must sterilize them before use.
• Physician’s postoperative directions and warning to the patient and the corresponding patient compliance are extremely important. Detailed instructions on the use and limitations of the device should be given to the patient.

Designed to allow for smooth surgical transitions, our system was developed by an expert team of physicians and engineers to achieve clinically predictable outcomes. The Responsive Orthopedics Total Knee Arthroplasty System was designed with 3 principles in mind:

1. Simplicity: Straightforward design combined with the essential instrumentation to achieve desired alignment and balance
2. Efficiency: Streamlined implant design with sizes to fit the most common patient types
3. Reproducibility: Multiple bearing-surface implant philosophies are manufactured in the United States using well-studied materials, and supported intra-operatively by a trained clinical specialist.

• A range of implant sizes designed to accommodate common patient types and sizes using well-established materials to ensure matching for patients while reducing inventory
• Symmetric poly design* (exception: Medial Pivot)
• Locking mechanism allows for intraoperative upsizing or downsizing of poly inserts to facilitate patient matching
• Surfaces include: Cruciate Retaining (CR), Posterior Stabilized (PS), Ultra Conforming (UCCS) and Medial Pivot (MPCS)