# K012778: Vaporized Hydrogen Peroxide (VHP) Sterilization of Uhmwpe Components in the Genesis Knee System, the Genesis II Knee Sys

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 15, 2002 after 207 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) The Genesis Knee System: named in the summary without a submission number
- (no number) The Genesis II Knee System: named in the summary without a submission number
- (no number) The Profix Knee System: named in the summary without a submission number

## Most influential descendants
- K053338: Arthrex Titanium and Bio-Degradable (Polymer) Implants (2006), 0 descendants of its own

## Indications for use
Components in the Genesis, Genesis II, and Profix Knee Systems are indicated for: 1) Rheumatoid arthritis; 2) Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result. 3) Failed osteotomies, unicompartmental replacement, or total knee replacement. 4) The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. 5) The constrained knee system is designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligaments) are absent or incompetent. The devices that are the subject of this premarket notification are intended for cemented use only and are for single use only. The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to terminally sterilize all orthopaedic implant components manufactured from UHMWPE material in the following product systems: o Genesis Knee System (i.e. tibial articular inserts, all polyethylene tibial bases, patellae, and flex-lok pegs) e Genesis II Knee System (i.e. tibial articular inserts, all polyethylene tibial bases, patellae, and flex-lok pegs) e Profix Knee System (i.e. tibial articular inserts, all polyethylene tibial bases, patellae)

Source page: https://510kreport.com/device/K012778
Methodology: https://510kreport.com/methodology