# K042757: Vanguard SSK Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 11, 2005 after 130 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915132 (1992). 3 ancestors in all.
23 later devices descend from it; 4 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023546: Maxim Accel Knee System, Biomet, Inc. (2003) Summary page 1.
- K915132: MCK Maximum Congruent Knee) Knee System, Biomet, Inc. (1992). Our reading of the summary gave K915332, FDA’s number for Model 795 Fluorometer/Densitometer (Ciba Corning Diagnostics Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Maximum Congruent Knee System”.

## Most influential descendants
- K093293: Vanguard 360 Revision Knee System (2010), 21 descendants of its own
- K122183: Augment and Screw, Psa Type (2013), 10 descendants of its own
- K121149: Vanguard SSK 360 Revision Knee System (2012), 7 descendants of its own
- K080204: Vanguard Knee System Titanium Femoral Components (2008), 6 descendants of its own
- K171054: Biomet Knee Joint Replacement Prostheses (2017), 5 descendants of its own

## Recalls of this device
- Feb 17, 2017 · Class II · Z-1861-2017: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

## Indications for use
1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. VanguardTM SSK components are intended for cemented use only.

Source page: https://510kreport.com/device/K042757
Methodology: https://510kreport.com/methodology