# K102367: Optigen Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corp.
- Decided: Dec 8, 2010 after 110 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933785 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K915132: MCK Maximum Congruent Knee) Knee System, Biomet, Inc. (1992) Summary page 1.
- K922285: Agc and Maxim Knee Components with NTS, Biomet, Inc. (1992) Summary page 1.
- K993159: Maxim Knee System, Biomet, Inc. (1999) Summary page 1.
- K884796: P.F.C.(TM) Modular Knee System, Johnson & Johnson Professionals, Inc. (1989) Summary page 1.
- K892394: P.F.C. Modular Knee System, Tibial Tray-Porous, Johnson & Johnson Professionals, Inc. (1989) Summary page 1.
- K935262: P.F.C. Total Knee System Oval Patella, Johnson & Johnson Orthopaedics, Inc. (1994) Summary page 1.
- K933785: Next Generation Knee System, Zimmer, Inc. (1995) Summary page 1.
- K023211: Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components, Zimmer, Inc. (2002) Summary page 1.
- K021657: Uknee Total Knee System, United Orthopedic Corp. (2002) Summary page 1.
- K892800: MG II Porous Total Knee System, Zimmer, Inc. (1989) Summary page 1.

## Indications for use
The OptiGenm Total Knee System is indicated for patients with severe knee pain and disability due to: * Rheumatoid arthritis * Post-traumatic arthritis, osteoarthritis, or degenerative arthritis * Failed osteotomies, unicompartmental replacement, or total knee replacement * Moderate varus, valgus, or flexion deformities This device is indicated for cemented use only.

Source page: https://510kreport.com/device/K102367
Methodology: https://510kreport.com/methodology