510(k) Report

510(k) · Cleared

Cleared

Copeland Resurfacing Heads

K003044510(k) TraditionalCleared Dec 13, 200075-day reviewClass II21 CFR 888.3690

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cleared on Dec 13, 2000 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 146 later devices descend from it.

Decided
Dec 13, 2000
Review
75 days
Class
Class II
Product code
HSD
Recalls
None
Predicates
0

146 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2016: 4 descendants cleared2019: 10 descendants cleared2014: 5 descendants cleared2001: 3 descendants cleared2003: 3 descendants cleared2013: 6 descendants cleared2012: 5 descendants cleared2005: 1 descendant cleared2006: 3 descendants cleared2007: 2 descendants cleared2008: 1 descendant cleared2018: 8 descendants cleared2022: 16 descendants cleared2021: 11 descendants cleared2025: 12 descendants cleared2011: 4 descendants cleared2024: 10 descendants cleared2015: 2 descendants cleared2017: 5 descendants cleared2020: 11 descendants cleared2026: 13 descendants cleared2023: 11 descendants cleared200020052010201520202025
  1. This deviceK003044 Copeland Resurfacing HeadsBiomet, Inc. · 2000
  2. Descendant · cites it directly · 142 of its ownK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
  3. Descendant · 2 generations on · 141 of its ownK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
  4. Descendant · cites it directly · 136 of its ownK010657 Copeland MB Resurfacing Humeral HeadsBiomet Manufacturing, Inc. · 2001
  5. Descendant · 3 generations on · 135 of its ownK033516 Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc. · 2003
  6. Descendant · 2 generations on · 121 of its ownK061862 Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc. · 2006

Showing 5 of 146 descendants. See all descendants

Descendants cleared per year

2001: 32003: 32005: 12006: 32007: 22008: 12011: 42012: 52013: 62014: 52015: 22016: 42017: 52018: 82019: 102020: 112021: 112022: 162023: 112024: 102025: 122026: 13
2001high 16 (2022) · low 0 (2002)2026

Most influential descendants

Showing 5 of 146 · See all
  • K010827Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · cites it directly142descendants
  • K031971Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003 · 2 generations on141descendants
  • K010657Copeland MB Resurfacing Humeral HeadsBiomet Manufacturing, Inc. · 2001 · cites it directly136descendants
  • K033516Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc. · 2003 · 3 generations on135descendants
  • K061862Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc. · 2006 · 2 generations on121descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003044Copeland Resurfacing HeadsBiomet, Inc.2000—
+1K010827Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc.20011
+2K031971Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc.2003—
+1K010657Copeland MB Resurfacing Humeral HeadsBiomet Manufacturing, Inc.2001—
+3K033516Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc.2003—
+2K061862Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200130
200330
200510
200630
200720
200810
201140
201250
201360
201450
201520
201640
201750
201880
2019100
2020110
2021110
2022160
2023110
2024100
2025120
2026130
FIG. 1 — Lineage of K003044, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (146)

See all 146

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K010827Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc.2001142
K010657Copeland MB Resurfacing Humeral HeadsBiomet Manufacturing, Inc.2001136
K010664Copeland Resurfacing Humeral HeadsBiomet Manufacturing, Inc.200114
K023096Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc.200310
K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167
K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192
K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemArthrosurface, Inc.20141

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?

  • Of its descendants, K010827 (Biomet Orthopedics, Inc., 2001) has gone furthest, with 142 descendants of its own.

How does its category compare?

All HSD devices

HSD 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

2007: 42008: 32011: 22012: 22013: 42014: 12016: 32018: 12020: 22022: 12024: 1
2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSD

145in 2016

2007: 72 days median2008: 92 days median2013: 218 days median2016: 145 days median
2007high 218 (2013) · low 72 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSD

1in 2020

2008: 22009: 22017: 32018: 12020: 1
2007high 3 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSD

757in 2025

2007: 1282008: 2592009: 1562010: 2252011: 2412012: 2542013: 2882014: 4342015: 5742016: 7842017: 9852018: 6492019: 8302020: 6582021: 5732022: 5082023: 5862024: 6932025: 757
2007high 985 (2017) · low 128 (2007)2025

MAUDE reports naming product code HSD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074720128
20083922259
20090—2156
20100—0225
20112—0241
20122—0254
201342180288
20141—0434
20150—0574
201631450784
20170—3985
20181—1649
20190—0830
20202—1658
20210—0573
20221—0508
20230—0586
20241—0693
20250—0757
20260—0—

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

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  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in HSD

The HSD category page

  • K233260Univers Revers CA Head and AdapterArthrex, Inc. · 2024
  • K221232Univers Revers Humeral Cup ImplantArthrex, Inc. · 2022
  • K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
  • K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC · 2020
  • K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018

https://510kreport.com/device/K003044 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003044: Copeland 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/K003044

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026