OptiGen Total Knee System
by U&I Corp. 510(k)
Active
510(k) K102367
Overview
The OptiGen Total Knee System is a semi-constrained cemented prosthesis designed for total knee arthroplasty. It replaces damaged joint surfaces in patients with severe osteoarthritis or other degenerative conditions, restoring mobility and relieving pain by providing a durable, load-bearing replacement for the knee joint. The system includes femoral components (posterior-stabilized and cruciate-retaining), tibial components, tibial bearings, patellar components, and accessory parts such as locking bars and cement plugs.
This device is supplied as a sterile, single-use orthopedic implant intended for surgical use in orthopedic settings. It is classified under FDA product code JWH and has received a 510(k) clearance (K102367) as substantially equivalent to a predicate device. Components are designed for cemented fixation and must be handled according to sterile surgical protocols. Storage and handling instructions are provided by the manufacturer to ensure integrity prior to use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102367 | Date8 Dec 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JWH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3560
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from U&I Corp.
Questions
What types of knee conditions is the OptiGen Total Knee System intended to address in patients?
The OptiGen Total Knee System is designed for patients with severe osteoarthritis or other degenerative joint conditions that have caused significant damage to the knee joint surfaces. It is specifically intended for total knee arthroplasty, replacing the damaged areas to restore mobility and relieve pain by providing a durable, load-bearing replacement for the knee joint.
Is the OptiGen Total Knee System reusable or single-use, and how should it be handled in the operating room?
The OptiGen Total Knee System is supplied as a sterile, single-use orthopedic implant. Due to its sterile packaging and intended surgical use, it must be handled according to strict sterile surgical protocols to maintain integrity before implantation. Reuse is not recommended or supported by the manufacturer.
What components are included in the OptiGen Total Knee System, and are there different types of femoral components available?
The system includes femoral components (both posterior-stabilized and cruciate-retaining options), tibial components, tibial bearings, patellar components, and accessory parts like locking bars and cement plugs. The availability of different femoral component types allows surgeons to choose based on the patient’s specific anatomical needs and clinical presentation.
How is the OptiGen Total Knee System fixed in place during surgery, and what does this mean for surgical planning?
The OptiGen Total Knee System is designed for cemented fixation, meaning bone cement is used to secure the prosthesis to the patient’s bone. This requires careful surgical planning to ensure proper preparation of the bone surfaces and accurate application of the cement, as outlined in the manufacturer’s instructions.
What storage and handling instructions should be followed to ensure the device remains intact before use?
The manufacturer provides specific storage and handling instructions to maintain the device’s integrity before surgery. Since it is sterile and single-use, it must be stored in a clean, dry environment away from direct sunlight or extreme temperatures, and the packaging should remain unopened until immediately before use to preserve sterility.