# K010664: Copeland Resurfacing Humeral Heads

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Apr 5, 2001 after 30 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
Longest line of descent: 1 generation back to K003044 (2000). 1 ancestor in all.
14 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003044: Copeland Resurfacing Heads, Biomet, Inc. (2000)

## Most influential descendants
- K023096: Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System (2003), 10 descendants of its own
- K131298: Exactech Equinoxe Resurfacing Humeral Head System (2013), 8 descendants of its own
- K152825: Catalyst CSR Shoulder System (2016), 7 descendants of its own
- K181287: Catalyst CSR Shoulder System (2018), 3 descendants of its own
- K182500: Catalyst CSR Press-Fit Humeral Components (2019), 2 descendants of its own

## Indications for use
The Copeland Resurfacing Humeral Heads are indicated for the following conditions where the humeral head and neck are of sufficient bone stock and there is presence of an intact or reconstructable rotator cuff which is necessary for proper functioning and dislocation resistance: 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Reconstructable rotator cuff 5) Treatment of fractures of the humeral head 6) Traumatic arthritis For cemented use only.

Source page: https://510kreport.com/device/K010664
Methodology: https://510kreport.com/methodology