510(k) · Cleared
ClearedCopeland Resurfacing Humeral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Apr 5, 2001 as substantially equivalent to K003044 (Biomet, Inc., 2000) after a 30-day review. Its family tree reaches back 1 generation to 2000. 14 later devices descend from it.
- Decided
- Apr 5, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003044 (2000). 14 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK003044 Copeland Resurfacing HeadsBiomet, Inc. · 2000
- This deviceK010664 Copeland Resurfacing Humeral HeadsBiomet Manufacturing, Inc. · 2001
- Descendant · cites it directly · 10 of its ownK023096 Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc. · 2003 · Recalled
- Descendant · 2 generations on · 8 of its ownK131298 Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc. · 2013
- Descendant · 2 generations on · 7 of its ownK152825 Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
- Descendant · 3 generations on · 3 of its ownK181287 Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK182500 Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc. · 2019
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K023096Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc. · 2003 · cites it directly10descendants
- K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc. · 2013 · 2 generations on8descendants
- K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016 · 2 generations on7descendants
- K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2018 · 3 generations on3descendants
- K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc. · 2019 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003044 | Copeland Resurfacing Heads | Biomet, Inc. | 2000 | — |
| 0 (this device) | K010664 | Copeland Resurfacing Humeral Heads | Biomet Manufacturing, Inc. | 2001 | — |
| +1 | K023096 | Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System | Std Mfg., Inc. | 2003 | 5 |
| +2 | K131298 | Exactech Equinoxe Resurfacing Humeral Head System | Exactech, Inc. | 2013 | — |
| +2 | K152825 | Catalyst CSR Shoulder System | Catalyst Orthoscience, LLC | 2016 | — |
| +3 | K181287 | Catalyst CSR Shoulder System | Catalyst Orthoscience, Inc. | 2018 | — |
| +3 | K182500 | Catalyst CSR Press-Fit Humeral Components | Catalyst Orthoscience, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K003044 | Copeland Resurfacing Heads | 2000 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023096 | Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System | 2003 | 10 |
| K062861 | Ascension Humeral Resurfacing Arthroplasty System | 2006 | 2 |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System | 2014 | 1 |
| K071064 | Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HA | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K010664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010664: Copeland Resurfacing Humeral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010664
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026