# K010827: Copeland MB/HA Resurfacing Humeral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Sep 14, 2001 after 178 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K800494 (1980). 6 ancestors in all.
142 later devices descend from it; 4 cite it directly.
0 of 149 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) Summary page 1.
- K002998: Biomet BI-Polar Shoulder System, Biomet, Inc. (2000) Summary page 1.
- K991585: Bipolar Shoulder Prosthesis, Biomet, Inc. (1999) Summary page 1.
- K992119: Bio-Modular Shoulder System, Biomet, Inc. (1999) Summary page 1.

## Most influential descendants
- K031971: Global Cap Resurfacing Replacement Shoulder (2003), 141 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
- K071147: Nexa Orthopedics Total Shoulder System (2007), 120 descendants of its own
- K102924: Aequalis Ascend Modular Anatomic Shoulder System (2011), 110 descendants of its own

## 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.

## Indications for use
The Copeland™ MB/HA 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 uncemented use only.

Source page: https://510kreport.com/device/K010827
Methodology: https://510kreport.com/methodology