# K951987: Genesis II Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Aug 22, 1995 after 117 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
254 later devices descend from it; 32 cite it directly.
0 of 255 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) Genesis I Total Knee System: named in the summary without a submission number
- (no number) Prodx Total Knee System: named in the summary without a submission number
- (no number) NexGen Knee System: named in the summary without a submission number
- (no number) P.F.C. Modular Knee System: named in the summary without a submission number
- (no number) OmniFit Total Knee System: named in the summary without a submission number
- (no number) Whiteside Ortholoc II Modular Knee System: named in the summary without a submission number
- (no number) AMK/Coordinate Knee System: named in the summary without a submission number

## Most influential descendants
- K030612: Genesis II Total Knee System (2003), 141 descendants of its own
- K042515: Smith & Nephew, Inc. High Performance Knee (2005), 118 descendants of its own
- K032295: Genesis II Posterior Stabilized High Flexion Articular Insert (2003), 76 descendants of its own
- K041825: Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert (2005), 75 descendants of its own
- K071071: Crosslinked Polyethylene Articular Inserts (2007), 66 descendants of its own

## Recalls of this device
- Jun 27, 2022 · Class II · Z-1418-2022: The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
- Jul 16, 2020 · Class II · Z-2774-2020: Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.
- Aug 1, 2017 · Class II · Z-2883-2018: Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
- Nov 9, 2015 · Class II · Z-0573-2016: One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes 
- Oct 7, 2013 · Class II · Z-0131-2014: Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
- Oct 7, 2013 · Class II · Z-0130-2014: Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

## Indications for use
The Genesis II Knee System is indicated for: 1. Rheumatoid arthritis. 2. Posttraumatic 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. The Genesis II Total Knee System is indicated for use only with cement and is a single use device.

Source page: https://510kreport.com/device/K951987
Methodology: https://510kreport.com/methodology