510(k) · Cleared
ClearedDepuy Global C.AP. Cta Resurfacing Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Aug 8, 2008 as substantially equivalent to K000575 (DePuy Orthopaedics, Inc., 2000) and 4 other predicates after a 123-day review. Its family tree reaches back 6 generations to 1980. 2 later devices descend from it.
- Decided
- Aug 8, 2008
- Review
- 123 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K800494 (1980). 28 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 5 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 4 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 3 generations backK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
- 2 generations backK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
- 1 generation backK051843 Copeland Eas Humeral Resurfacing HeadsBiomet, Inc. · 2005 · Recalled
- This deviceK080990 Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc. · 2008
- Descendant · cites it directly · 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −5 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −4 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −3 | K010827 | Copeland MB/HA Resurfacing Humeral Heads | Biomet Orthopedics, Inc. | 2001 | 1 |
| −2 | K031971 | Global Cap Resurfacing Replacement Shoulder | DePuy Orthopaedics, Inc. | 2003 | — |
| −1 | K051843 | Copeland Eas Humeral Resurfacing Heads | Biomet, Inc. | 2005 | 1 |
| 0 (this device) | K080990 | Depuy Global C.AP. Cta Resurfacing Shoulder | DePuy Orthopaedics, Inc. | 2008 | — |
| +1 | 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 | 3 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2021 | 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? (5)
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 |
|---|---|---|---|
| * | K000575 | Global Advantage Extended Humeral HeadSummary page 1…DEVICE PRODUCT CODE: 87HSD SUBSTANTIALLY EQUIVALENT DePuy Global Advantage® Extended Humeral DEVICE(S): Head, K000575 Copeland' M T… | 2000 |
| * | K051843 | Copeland Eas Humeral Resurfacing HeadsSummary page 1…T EAS Humeral Resurfacing Heads, K051843 DVO TMTotal Extended Articulation Humeral Heads, K073… | 2005 |
| * | K073331 | Dvo Extended Articulation Humeral HeadsSummary page 1…K051843 DVO TMTotal Extended Articulation Humeral Heads, K073331 DePuy Global C.A.P. TM Resurfacing Replacement Should… | 2008 |
| * | K031971 | Global Cap Resurfacing Replacement ShoulderSummary page 1…Heads, K073331 DePuy Global C.A.P. TM Resurfacing Replacement Shoulder, K031971 Copeland MB/HA Resurfacing Humeral Heads,… | 2003 |
| * | K010827 | Copeland MB/HA Resurfacing Humeral HeadsSummary page 1…esurfacing Humeral Heads, M T K010827 DEVICE DESCRIPTION: The DePuy Global C.A.P. CTA Resurfacing Shoulder is a conservative Cuff Tear Arthropathy (CT… | 2001 |
| † | K033516 | Depuy Global Cap HA Resurfacing Shoulder Humeral Heads | 2003 |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 28 ancestors have a recall of any class.
- Of its descendants, K203230 (Depuy Lnc., 2021) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K000575.
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. 2008, this device’s year, is highlighted.
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 DePuy Global C.A.P. CTA Resurfacing Shoulder is indicated for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:
1. Rotator cuff tear arthropathy.
2. Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.
CAUTION: The DePuy Global C.A.P. CTA Resurfacing Shoulder is intended for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080990: Depuy Global C.AP. Cta Resurfacing Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080990
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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