# K010635: Interlok / HA Copeland Resurfacing Heads

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 20, 2001 after 171 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Aug 21, 2019 · Class II · Z-0527-2020: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

Source page: https://510kreport.com/device/K010635
Methodology: https://510kreport.com/methodology