# K911684: Biomet Cobalt-Chrome Femoral Components

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jun 27, 1991 after 72 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
56 later devices descend from it; 3 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K121874: G7 Acetabular System (2012), 53 descendants of its own
- K140669: G7 Osseoti Acetublar Shells (2014), 35 descendants of its own
- K142882: G7 Freedom and Offset Liners, Freedom Head, Size 32 (2015), 17 descendants of its own
- K221479: Persona Personalized Knee System (2022), 8 descendants of its own
- K182321: MobileLink Acetabular Cup System (2019), 8 descendants of its own

## Recalls of this device
- Apr 2, 2018 · Class II · Z-1537-2018: Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
- Apr 16, 2015 · Class III · Z-1757-2015: Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
- Jun 18, 2003 · Not classified · Z-1285-03: The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Jun 18, 2003 · Not classified · Z-1282-03: The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Jun 18, 2003 · Not classified · Z-1283-03: The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Jun 18, 2003 · Not classified · Z-1281-03: The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Jun 18, 2003 · Not classified · Z-1290-03: The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Jun 18, 2003 · Not classified · Z-1288-03: The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Jun 18, 2003 · Not classified · Z-1287-03: The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Jun 18, 2003 · Not classified · Z-1284-03: The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Jun 18, 2003 · Not classified · Z-1286-03: The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Jun 18, 2003 · Not classified · Z-1289-03: The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.

Source page: https://510kreport.com/device/K911684
Methodology: https://510kreport.com/methodology