# K915132: MCK Maximum Congruent Knee) Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 11, 1992 after 90 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.
315 later devices descend from it; 14 cite it directly.
0 of 316 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K023546: Maxim Accel Knee System (2003), 305 descendants of its own
- K050222: Vanguard Anterior Stabilized Tibial Bearings (2005), 255 descendants of its own
- K041046: Maxim Accel (Vanguard) PS+ Bearings (2004), 249 descendants of its own
- K080528: E-Poly Tibial Bearings (2008), 248 descendants of its own
- K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 (2010), 119 descendants of its own

## Recalls of this device
- May 18, 2018 · Class II · Z-2177-2018: One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component a
- Apr 16, 2015 · Class III · Z-1756-2015: Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
- Mar 3, 2011 · Not classified · Z-2104-2011: The firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".
- Dec 12, 2007 · Not classified · Z-0706-2008: Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.
- Dec 12, 2007 · Not classified · Z-0707-2008: Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.
- Sep 18, 2007 · Not classified · Z-0255-2008: Mislabeled as to size: the package actaully contained a 71 mm tray.

Source page: https://510kreport.com/device/K915132
Methodology: https://510kreport.com/methodology