# K023546: Maxim Accel Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jan 17, 2003 after 87 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: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915132 (1992). 2 ancestors in all.
305 later devices descend from it; 15 cite it directly.
0 of 308 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915132: MCK Maximum Congruent Knee) Knee System, Biomet, Inc. (1992) Summary page 1.
- K936274: Kirschner Performance Posterior Stabilized Total Knee System, Kirschner Medical Corp. (1995) Summary page 1.

## Most influential descendants
- 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
- K100048: E1 Antioxidant Infused Technology (2010), 114 descendants of its own

## Recalls of this device
- Apr 17, 2020 · Class II · Z-2150-2020: Potential presence of elevated endotoxin levels that exceed the specification limit
- Apr 17, 2020 · Class II · Z-2153-2020: Potential presence of elevated endotoxin levels that exceed the specification limit
- Oct 22, 2018 · Class II · Z-0495-2019: Label on the outer carton or the patient labels does not match label on the inner sterile packaging
- Oct 22, 2018 · Class II · Z-0496-2019: Label on the outer carton or the patient labels does not match label on the inner sterile packaging
- Sep 29, 2017 · Class II · Z-0673-2018: Knee implant components (tibial bearings) are labeled with the incorrect size.
- Sep 29, 2017 · Class II · Z-0674-2018: Knee implant components (tibial bearings) are labeled with the incorrect size.
- Jan 4, 2017 · Class II · Z-1115-2017: packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.
- Aug 9, 2016 · Class II · Z-0111-2017: Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM Risks: Adverse
- Jul 6, 2011 · Not classified · Z-2945-2011: The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless.
- Apr 20, 2010 · Not classified · Z-2204-2010: A knee implant labeled as left was opened and the package actually contained a right knee implant.
- Feb 12, 2008 · Not classified · Z-1375-2008: Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat s
- Feb 12, 2008 · Not classified · Z-1376-2008: Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat s
- Aug 31, 2007 · Not classified · Z-0123-2008: Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.

## 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. The device is a single use implant intended for implantation with bone cement.

Source page: https://510kreport.com/device/K023546
Methodology: https://510kreport.com/methodology