510(k) Report

510(k) · Cleared

Cleared

Copeland MB Resurfacing Humeral Heads

K010657510(k) TraditionalCleared Sep 14, 2001192-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 Manufacturing, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cleared on Sep 14, 2001 as substantially equivalent to K003044 (Biomet, Inc., 2000) and 3 other predicates after a 192-day review. Its family tree reaches back 3 generations to 1980. 136 later devices descend from it.

Decided
Sep 14, 2001
Review
192 days
Class
Class II
Product code
HSD
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K800494 (1980). 6 ancestors in all. 136 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor1980: 1 other ancestor2013: 5 descendants cleared2012: 5 descendants cleared2005: 1 descendant cleared2006: 2 descendants cleared2008: 1 descendant cleared2007: 2 descendants cleared2016: 4 descendants cleared2019: 10 descendants cleared2022: 15 descendants cleared2011: 4 descendants cleared2021: 11 descendants cleared2018: 8 descendants cleared2025: 12 descendants cleared2015: 2 descendants cleared2014: 4 descendants cleared2017: 5 descendants cleared2020: 11 descendants cleared2026: 13 descendants cleared2023: 11 descendants cleared2024: 10 descendants clearedK800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 1980K991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 6 descendants3 generations forward: 8 descendants4 generations forward: 8 descendants5 generations forward: 15 descendants6 generations forward: 17 descendants7 generations forward: 20 descendants8 generations forward: 30 descendants9 generations forward: 16 descendants10 generations forward: 6 descendants11 generations forward: 2 descendants12 generations forward: 2 descendants13 generations forward: 1 descendant K002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalledK991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 19800+5+10
  1. Root · 3 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
  2. 2 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
  3. 1 generation backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
  4. This deviceK010657 Copeland MB Resurfacing Humeral HeadsBiomet Manufacturing, Inc. · 2001
  5. Descendant · cites it directly · 121 of its ownK061862 Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc. · 2006
  6. Descendant · 2 generations on · 120 of its ownK071147 Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007
  7. Descendant · 3 generations on · 110 of its ownK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
  8. Descendant · 4 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  9. Descendant · 3 generations on · 105 of its ownK113413 Ascend Shoulder SystemTornier, Inc. · 2012

Showing 5 of 136 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22007: 22008: 12011: 42012: 52013: 52014: 42015: 22016: 42017: 52018: 82019: 102020: 112021: 112022: 152023: 112024: 102025: 122026: 13
2005high 15 (2022) · low 0 (2009)2026

Most influential descendants

Showing 5 of 136 · See all
  • K061862Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc. · 2006 · cites it directly121descendants
  • K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007 · 2 generations on120descendants
  • K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · 3 generations on110descendants
  • K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 4 generations on108descendants
  • K113413Ascend Shoulder SystemTornier, Inc. · 2012 · 3 generations on105descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K800494New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc.1980—
−2K991585Bipolar Shoulder ProsthesisBiomet, Inc.1999—
−1K002998Biomet BI-Polar Shoulder SystemBiomet, Inc.20001
0 (this device)K010657Copeland MB Resurfacing Humeral HeadsBiomet Manufacturing, Inc.2001—
+1K061862Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc.2006—
+2K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007—
+3K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011—
+4K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
+3K113413Ascend Shoulder SystemTornier, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200720
200810
201140
201250
201350
201440
201520
201640
201750
201880
2019100
2020110
2021110
2022150
2023110
2024100
2025120
2026130
FIG. 1 — Lineage of K010657, 1980–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K003044Copeland Resurfacing Heads
Summary page 1
…Code: HSD (21 CFR 888.3690) MBF (unknown, recently down classified) Legally Marketed Devices To Which Substantial Equivalence is Claimed: Copeland™ Resurfacing Heads (K003044), Bi-Polar Shoulder (K002998), Bi-Polar Shoulder System (K991585), and Bio-Modular® Shoulder System (K992119). Intended Use: The…
Biomet, Inc.2000—
*K002998Biomet BI-Polar Shoulder System
Summary page 1
…MBF (unknown, recently down classified) Legally Marketed Devices To Which Substantial Equivalence is Claimed: Copeland™ Resurfacing Heads (K003044), Bi-Polar Shoulder (K002998), Bi-Polar Shoulder System (K991585), and Bio-Modular® Shoulder System (K992119). Intended Use: The Copeland™ MB Resurfacing Hum…
Biomet, Inc.20001
*K991585Bipolar Shoulder Prosthesis
Summary page 1
…ied) Legally Marketed Devices To Which Substantial Equivalence is Claimed: Copeland™ Resurfacing Heads (K003044), Bi-Polar Shoulder (K002998), Bi-Polar Shoulder System (K991585), and Bio-Modular® Shoulder System (K992119). Intended Use: The Copeland™ MB Resurfacing Humeral Heads are indicated for the fol…
Biomet, Inc.1999—
*K992119Bio-Modular Shoulder System
Summary page 1
…tantial Equivalence is Claimed: Copeland™ Resurfacing Heads (K003044), Bi-Polar Shoulder (K002998), Bi-Polar Shoulder System (K991585), and Bio-Modular® Shoulder System (K992119). Intended Use: The Copeland™ MB Resurfacing Humeral Heads are indicated for the following conditions where the humeral head and…
Biomet, Inc.19991

Also cleared against K003044: 6 other devices →

What descends from it? (136)

See all 136

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

NumberDeviceApplicantDecidedDescendants
K061862Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc.2006121
K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.20138
K051843Copeland Eas Humeral Resurfacing HeadsBiomet, Inc.20056
K130635Seviin Surface Replacement ShoulderIngen Orthopedics, LLC20130
K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A.20120

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 21 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K061862 (Axiom Orthopaedics, Inc., 2006) has gone furthest, with 121 descendants of its own.
  • 6 other devices also cite its predicate K003044.

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—

What is it indicated for?

The Copeland™ MB 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 uncemented use only,

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K003044

6 other devices cite the same predicate.

  • K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc. · 2019
  • K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
  • K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemArthrosurface, Inc. · 2014
  • K023096Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc. · 20035 recalls
  • K010827Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 20011 recall
  • K010664Copeland Resurfacing Humeral HeadsBiomet Manufacturing, Inc. · 2001

More from Biomet Manufacturing, Inc.

32 FDA decisions under this applicant name. See the company

  • K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc. · 20131 recall
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
  • K080685Hiploc Compression Hip ScrewBiomet Manufacturing, Inc. · 20084 recalls
  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 20088 recalls

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/K010657 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010657: Copeland MB 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/K010657

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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