# K123159: Smith & Newphew, Inc. Disposable Knee Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: May 3, 2013 after 206 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: 6 generations back to K951987 (1995). 44 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093746: Verilast Wear Claims for the Legion Primary Knee System, Smith & Nephew, Inc. (2010) Summary page 1.
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K032295: Genesis II Posterior Stabilized High Flexion Articular Insert, Smith & Nephew, Inc. (2003) Summary page 1.
- K041825: Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert, Smith & Nephew, Inc. (2005) Summary page 1.
- K121393: Smith & Nephew, Inc. Total Knee System Instrumentation, Smith & Nephew, Inc. (2012) Summary page 1.

## Most influential descendants
- K143226: Visionaire Disposable Instruments (2015), 0 descendants of its own
- K141585: Smith & Nephew Disposable Fin Punch (2014), 0 descendants of its own

## Indications for use
Smith & Nephew Disposable Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew, Inc. Genesis 11and Legions total knee systems and their cleared indications for use for Total Knee Replacement.

Source page: https://510kreport.com/device/K123159
Methodology: https://510kreport.com/methodology