# K863668: Omnifit (TM) Total Knee Prosthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Dec 19, 1986 after 92 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K170534: Prolixus Total Knee System (2017), 2 descendants of its own
- K231975: PNK Total Knee System (2023), 0 descendants of its own
- K191192: SurgTech GENOLL Total Knee System (2019), 0 descendants of its own
- K020830: Scorpio Inset Patellar Component (2002), 0 descendants of its own

## Recalls of this device
- Dec 1, 2023 · Class II · Z-0869-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0870-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0871-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0872-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Source page: https://510kreport.com/device/K863668
Methodology: https://510kreport.com/methodology