# K003044: Copeland Resurfacing Heads

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 13, 2000 after 75 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
146 later devices descend from it; 7 cite it directly.
0 of 147 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
- K010827: Copeland MB/HA Resurfacing Humeral Heads (2001), 142 descendants of its own
- K031971: Global Cap Resurfacing Replacement Shoulder (2003), 141 descendants of its own
- K010657: Copeland MB Resurfacing Humeral Heads (2001), 136 descendants of its own
- K033516: Depuy Global Cap HA Resurfacing Shoulder Humeral Heads (2003), 135 descendants of its own
- K061862: Axiom Orthopaedics Shoulder Resurfacing System (2006), 121 descendants of its own

Source page: https://510kreport.com/device/K003044
Methodology: https://510kreport.com/methodology