# K051843: Copeland Eas Humeral Resurfacing Heads

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Sep 29, 2005 after 84 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: 5 generations back to K800494 (1980). 21 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 4.
- K010657: Copeland MB Resurfacing Humeral Heads, Biomet Manufacturing, Inc. (2001) Summary page 4.
- K000575: Global Advantage Extended Humeral Head, DePuy Orthopaedics, Inc. (2000) Summary page 4.
- K031971: Global Cap Resurfacing Replacement Shoulder, DePuy Orthopaedics, Inc. (2003) Summary page 4.

## Most influential descendants
- K080990: Depuy Global C.AP. Cta Resurfacing Shoulder (2008), 2 descendants of its own
- K062861: Ascension Humeral Resurfacing Arthroplasty System (2006), 2 descendants of its own
- K213827: TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) (2022), 0 descendants of its own
- K203230: Global Shoulder and Delta CTA systems (2021), 0 descendants of its own
- K112900: SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral Heads (2012), 0 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 Extended Articulating Surface (EAS) Resurfacing Heads are indicated for hemi- or total shoulder replacement in patients with massive, irreparable rotator cuff tears and arthritis. Specific indications include: 1) Cuff tear arthropathy. 2) Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate. Implants with Interlok®/hydroxyapatite coating are cleared for uncemented applications. Implants with MacroBond® and MacroBond® coating with hydroxyapatite are cleared for cemented and uncemented applications; however, cement should only be applied to the surfaces that do not contain hydroxyapatite coating (i.e. stem).

Source page: https://510kreport.com/device/K051843
Methodology: https://510kreport.com/methodology