# K010657: Copeland MB Resurfacing Humeral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Sep 14, 2001 after 192 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: 3 generations back to K800494 (1980). 6 ancestors in all.
136 later devices descend from it; 5 cite it directly.
0 of 143 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
- 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
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K113413: Ascend Shoulder System (2012), 105 descendants of its own

## Indications for use
The Copeland™ MB 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/K010657
Methodology: https://510kreport.com/methodology