# K921182: Ultra High Molecular Weight Polyethylene Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 23, 1993 after 500 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
55 later devices descend from it; 5 cite it directly.
0 of 56 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
- K040770: Vanguard Patella Components (2004), 54 descendants of its own
- K061340: 23 MM Single-Peg Patella Component (2006), 47 descendants of its own
- K113550: Vanguard Complete Knee System (2012), 46 descendants of its own
- K221479: Persona Personalized Knee System (2022), 8 descendants of its own
- K151266: Physica CR Knee System (2015), 8 descendants of its own

## Recalls of this device
- Apr 17, 2020 · Class II · Z-2149-2020: Potential presence of elevated endotoxin levels that exceed the specification limit
- Jul 24, 2007 · Not classified · Z-0076-2008: Incorrect Product -- Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.
- Jul 24, 2007 · Not classified · Z-0077-2008: Incorrect Product -- Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.

Source page: https://510kreport.com/device/K921182
Methodology: https://510kreport.com/methodology