510(k) Report

510(k) · Cleared

Cleared

Aequalis Resurfacing Head

K062661510(k) TraditionalCleared Dec 22, 2006106-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

Tornier · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cleared on Dec 22, 2006 as substantially equivalent to K952928 (Tornier, 1995) and 9 other predicates after a 106-day review. Its family tree reaches back 6 generations to 1980. 16 later devices descend from it.

Decided
Dec 22, 2006
Review
106 days
Class
Class II
Product code
HSD
Recalls
None
Predicates
10

Its longest line of descent runs back 6 generations to K800494 (1980). 22 ancestors in all. 16 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2004: 2 other ancestors2003: 1 other ancestor2001: 1 other ancestor2000: 4 other ancestors1995: 1 other ancestor1999: 1 other ancestor1996: 1 other ancestor1987: 1 other ancestor1993: 1 other ancestor1991: 1 other ancestor1980: 1 other ancestor2013: 3 descendants cleared2022: 2 descendants cleared2014: 1 descendant cleared2016: 2 descendants cleared2019: 2 descendants cleared2018: 3 descendants cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 1980K991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalledK010827 · Copeland MB/HA Resurfacing Humeral Heads · Biomet Orthopedics, Inc. · 2001 · recalled×2: 2 generations cleared close together, K031971 (2003), K033516 (2003) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 5 other ancestors3 generations back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 6 descendants4 generations forward: 3 descendants K033516 · Depuy Global Cap HA Resurfacing Shoulder Humeral Heads · DePuy Orthopaedics, Inc. · 2003K031971 · Global Cap Resurfacing Replacement Shoulder · DePuy Orthopaedics, Inc. · 2003K010827 · Copeland MB/HA Resurfacing Humeral Heads · Biomet Orthopedics, Inc. · 2001 · recalledK002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalledK991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 1980−50
  1. Root · 6 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
  2. 5 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
  3. 4 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
  4. 3 generations backK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
  5. 2 generations backK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
  6. 1 generation backK033516 Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc. · 2003
  7. This deviceK062661 Aequalis Resurfacing HeadTornier · 2006
  8. Descendant · cites it directly · 8 of its ownK131298 Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc. · 2013
  9. Descendant · 2 generations on · 7 of its ownK152825 Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
  10. Descendant · cites it directly · 5 of its ownK131231 Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2013
  11. Descendant · 3 generations on · 3 of its ownK181287 Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2018
  12. Descendant · 2 generations on · 2 of its ownK220914 Tornier Perform Humeral System – FractureTornier, Inc. · 2022

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2013: 32014: 12016: 22018: 32019: 22022: 22024: 12025: 12026: 1
2013high 3 (2013) · low 0 (2015)2026

Most influential descendants

Showing 5 of 16 · See all
  • K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc. · 2013 · cites it directly8descendants
  • K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016 · 2 generations on7descendants
  • K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S. · 2013 · cites it directly5descendants
  • K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2018 · 3 generations on3descendants
  • K220914Tornier Perform Humeral System – FractureTornier, Inc. · 2022 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K800494New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc.1980—
−5K991585Bipolar Shoulder ProsthesisBiomet, Inc.1999—
−4K002998Biomet BI-Polar Shoulder SystemBiomet, Inc.20001
−3K010827Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc.20011
−2K031971Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc.2003—
−1K033516Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc.2003—
0 (this device)K062661Aequalis Resurfacing HeadTornier2006—
+1K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.2013—
+2K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC2016—
+1K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis…Tornier S.A.S.2013—
+3K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.2018—
+2K220914Tornier Perform Humeral System – FractureTornier, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198710
199110
199310
199510
199610
199910
200040
200110
200310
200420
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201330
201410
201620
201830
201920
202220
202410
202510
202610
FIG. 1 — Lineage of K062661, 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? (10)

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
*K952928Aequalis Shoulder System for Total & Hemishoulder Applications
Summary page 1
…Device class: Class II Classification panel: Orthopedic Product code: HSD 5) Equivalent / Predicate device Aequalis Shoulder System, Tomier, K952928, K012212, K041339, K043077, K060209 Aequalis Shoulder Fracture System, Tonier, K994392, K003728, K032679, K043077, K060209 Copela…
Tornier1995—
*K012212Modification to Aequalis Shoulder System
Summary page 1
…ass: Class II Classification panel: Orthopedic Product code: HSD 5) Equivalent / Predicate device Aequalis Shoulder System, Tomier, K952928, K012212, K041339, K043077, K060209 Aequalis Shoulder Fracture System, Tonier, K994392, K003728, K032679, K043077, K060209 Copeland MB/HA…
Tornier2001—
*K041339Aequalis Shoulder System
Summary page 1
…Class II Classification panel: Orthopedic Product code: HSD 5) Equivalent / Predicate device Aequalis Shoulder System, Tomier, K952928, K012212, K041339, K043077, K060209 Aequalis Shoulder Fracture System, Tonier, K994392, K003728, K032679, K043077, K060209 Copeland MB/HA Resurfaci…
Tornier2004—
*K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System
Summary page 1
…lass II Classification panel: Orthopedic Product code: HSD 5) Equivalent / Predicate device Aequalis Shoulder System, Tomier, K952928, K012212, K041339, K043077, K060209 Aequalis Shoulder Fracture System, Tonier, K994392, K003728, K032679, K043077, K060209 Copeland MB/HA Resurfacing Humera…
Tornier2004—
*K060209Aequalis Shoulder Fracture System & Aequalis Shoulder System
Summary page 1
…lassification panel: Orthopedic Product code: HSD 5) Equivalent / Predicate device Aequalis Shoulder System, Tomier, K952928, K012212, K041339, K043077, K060209 Aequalis Shoulder Fracture System, Tonier, K994392, K003728, K032679, K043077, K060209 Copeland MB/HA Resurfacing Humeral Head, B…
Tornier2006—
*K994392Aequalis Shoulder Fracture System
Summary page 1
…HSD 5) Equivalent / Predicate device Aequalis Shoulder System, Tomier, K952928, K012212, K041339, K043077, K060209 Aequalis Shoulder Fracture System, Tonier, K994392, K003728, K032679, K043077, K060209 Copeland MB/HA Resurfacing Humeral Head, Biomet, Inc, K010827 Global CAP resurfacing Replacem…
Tornier2000—
*K003728Modification to Aequalis Shoulder Fracture System
Summary page 1
…HSD 5) Equivalent / Predicate device Aequalis Shoulder System, Tomier, K952928, K012212, K041339, K043077, K060209 Aequalis Shoulder Fracture System, Tonier, K994392, K003728, K032679, K043077, K060209 Copeland MB/HA Resurfacing Humeral Head, Biomet, Inc, K010827 Global CAP resurfacing Replacement Shoul…
Tornier2000—
*K032679Aequalis Shoulder Fracture System
Summary page 1
…Equivalent / Predicate device Aequalis Shoulder System, Tomier, K952928, K012212, K041339, K043077, K060209 Aequalis Shoulder Fracture System, Tonier, K994392, K003728, K032679, K043077, K060209 Copeland MB/HA Resurfacing Humeral Head, Biomet, Inc, K010827 Global CAP resurfacing Replacement Shoulder, DePu…
Tornier2003—
*K010827Copeland MB/HA Resurfacing Humeral Heads
Summary page 1
…2, K041339, K043077, K060209 Aequalis Shoulder Fracture System, Tonier, K994392, K003728, K032679, K043077, K060209 Copeland MB/HA Resurfacing Humeral Head, Biomet, Inc, K010827 Global CAP resurfacing Replacement Shoulder, DePuy Orthopaedics, Inc, K033516 6) Device description The Aequalis Resurfacing Hea…
Biomet Orthopedics, Inc.20011
*K033516Depuy Global Cap HA Resurfacing Shoulder Humeral Heads
Summary page 1
…2, K003728, K032679, K043077, K060209 Copeland MB/HA Resurfacing Humeral Head, Biomet, Inc, K010827 Global CAP resurfacing Replacement Shoulder, DePuy Orthopaedics, Inc, K033516 6) Device description The Aequalis Resurfacing Head is a humeral head resurfacing device. It requires less bone and cartilage re…
DePuy Orthopaedics, Inc.2003—

Also cleared against K952928: 18 other devices →

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.20138
K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135
K130635Seviin Surface Replacement ShoulderIngen Orthopedics, LLC20130

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 26 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
  • 3 of the 22 ancestors have a recall of any class.
  • Of its descendants, K131298 (Exactech, Inc., 2013) has gone furthest, with 8 descendants of its own.
  • 18 other devices also cite its predicate K952928.

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 Aequalis Resurfacing Head is indicated as a total or hemi shoulder joint replacement where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable.

The replacement of the joint with this device is indicated to relieve severe pain or significant disability caused by:

- Degenerative pathologies: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis. Primary and secondary necrosis of the humeral head.

- Humeral head fracture.

The Aequalis Resurfacing Head is intended for uncemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K952928

18 other devices cite the same predicate.

  • K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014
  • K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture…Tornier · 2012
  • K111902Aequalis Shoulder SystemTornier · 2011
  • K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
  • K081059Aequalis Reversed Shoulder ProsthesisTornier · 2008
  • K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc. · 2008

More from Tornier

44 FDA decisions under this applicant name. See the company

  • K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture…Tornier · 2012
  • K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier · 2012
  • K111902Aequalis Shoulder SystemTornier · 2011
  • K094013HLS Kneetec SystemTornier · 2011
  • K100142Aequalis Reversed Shoulder ProsthesisTornier · 2010

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/K062661 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062661: Aequalis Resurfacing Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062661

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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