510(k) · Cleared
Recalled · Class II · 2019Copeland Eas Humeral Resurfacing Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Sep 29, 2005 as substantially equivalent to K030710 (Biomet, Inc., 2003) and 3 other predicates after an 84-day review. Its family tree reaches back 5 generations to 1980. 6 later devices descend from it. It has been recalled once.
- Decided
- Sep 29, 2005
- Review
- 84 days
- Class
- Class II
- Product code
- HSD
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 5 generations to K800494 (1980). 21 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 4 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 3 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 2 generations backK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
- 1 generation backK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
- This deviceK051843 Copeland Eas Humeral Resurfacing HeadsBiomet, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK080990 Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK062861 Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK213827 TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System…Smith & Nephew, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK203230 Global Shoulder and Delta CTA systemsDepuy Lnc. · 2021
- Descendant · cites it directly · 0 of its ownK112900 SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc. · 2008 · cites it directly2descendants
- K062861Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc. · 2006 · cites it directly2descendants
- K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc. · 2022 · 2 generations on0descendants
- K203230Global Shoulder and Delta CTA systemsDepuy Lnc. · 2021 · 2 generations on0descendants
- K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −4 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −3 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −2 | K010827 | Copeland MB/HA Resurfacing Humeral Heads | Biomet Orthopedics, Inc. | 2001 | 1 |
| −1 | K031971 | Global Cap Resurfacing Replacement Shoulder | DePuy Orthopaedics, Inc. | 2003 | — |
| 0 (this device) | K051843 | Copeland Eas Humeral Resurfacing Heads | Biomet, Inc. | 2005 | — |
| +1 | K080990 | Depuy Global C.AP. Cta Resurfacing Shoulder | DePuy Orthopaedics, Inc. | 2008 | — |
| +1 | K062861 | Ascension Humeral Resurfacing Arthroplasty System | Ascension Orthopedics, Inc. | 2006 | 1 |
| +2 | K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN… | Smith & Nephew, Inc. | 2022 | — |
| +2 | K203230 | Global Shoulder and Delta CTA systems | Depuy Lnc. | 2021 | — |
| +1 | K112900 | SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral Heads | Lima Corporate S.P.A. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030710 | Bio-Modular Shoulder SystemSummary page 4…r uncemented (888.3670) %Prosthesis, shoulder, hemi-, humeral, metallic uncemented (888.3690) Substantially Equivalent Devices: Bio-Modular'~ EAS Heads- K030710 (Biomet); Copeland' Tm Resurfacing Heads - K010657 (Biomet); GlobalI'Tm Advantage Extended Humeral Heads - K000575 (… | 2003 |
| * | K010657 | Copeland MB Resurfacing Humeral HeadsSummary page 4…umeral, metallic uncemented (888.3690) Substantially Equivalent Devices: Bio-Modular'~ EAS Heads- K030710 (Biomet); Copeland' Tm Resurfacing Heads - K010657 (Biomet); GlobalI'Tm Advantage Extended Humeral Heads - K000575 (DePuy); Global TTM C.AP. Resurfacing Replacement Shoulder- K0319… | 2001 |
| * | K000575 | Global Advantage Extended Humeral HeadSummary page 4…Devices: Bio-Modular'~ EAS Heads- K030710 (Biomet); Copeland' Tm Resurfacing Heads - K010657 (Biomet); GlobalI'Tm Advantage Extended Humeral Heads - K000575 (DePuy); Global TTM C.AP. Resurfacing Replacement Shoulder- K031971 (DePuy) Device Description: These devices are intended for u… | 2000 |
| * | K031971 | Global Cap Resurfacing Replacement ShoulderSummary page 4…' Tm Resurfacing Heads - K010657 (Biomet); GlobalI'Tm Advantage Extended Humeral Heads - K000575 (DePuy); Global TTM C.AP. Resurfacing Replacement Shoulder- K031971 (DePuy) Device Description: These devices are intended for use in patients with an irreparable rotator cuff as a shoulder replac… | 2003 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2019 | Class II | Z-0527-2020 | Environmental control | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K080990 (DePuy Orthopaedics, Inc., 2008) has gone furthest, with 2 descendants of its own.
- 19 other devices also cite its predicate K030710.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051843: Copeland Eas Humeral Resurfacing Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051843
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026