510(k) Report

510(k) · Cleared

Cleared

Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System

K043077510(k) TraditionalCleared Dec 17, 200439-day reviewClass II21 CFR 888.3660

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

Tornier · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Dec 17, 2004 as substantially equivalent to K952928 (Tornier, 1995) and 6 other predicates after a 39-day review. Its family tree reaches back 3 generations to 1993. 258 later devices descend from it.

Decided
Dec 17, 2004
Review
39 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K920362 (1993). 9 ancestors in all, the oldest K873679 (1987). 258 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2000: 2 other ancestors1995: 1 other ancestor1987: 1 other ancestor1996: 1 other ancestor2006: 5 descendants cleared2008: 3 descendants cleared2012: 7 descendants cleared2010: 5 descendants cleared2013: 8 descendants cleared2014: 11 descendants cleared2011: 10 descendants cleared2007: 2 descendants cleared2017: 14 descendants cleared2020: 18 descendants cleared2016: 12 descendants cleared2019: 20 descendants cleared2015: 6 descendants cleared2026: 22 descendants cleared2021: 22 descendants cleared2022: 22 descendants cleared2018: 17 descendants cleared2024: 16 descendants cleared2025: 21 descendants cleared2023: 17 descendants clearedK920362 · 3M Modular Shoulder System · 3M Health Care, Ltd. · 1993K002683 · WMT Ultra-Fit Modular Shoulder System · Wrightmedicaltechnologyinc · 2000K032679 · Aequalis Shoulder Fracture System · Tornier · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 22 descendants3 generations forward: 54 descendants4 generations forward: 70 descendants5 generations forward: 50 descendants6 generations forward: 30 descendants7 generations forward: 17 descendants8 generations forward: 6 descendants9 generations forward: 2 descendants10 generations forward: 1 descendant K032679 · Aequalis Shoulder Fracture System · Tornier · 2003K002683 · WMT Ultra-Fit Modular Shoulder System · Wrightmedicaltechnologyinc · 2000K920362 · 3M Modular Shoulder System · 3M Health Care, Ltd. · 19930+5+10
  1. Root · 3 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
  2. 2 generations backK002683 WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc · 2000
  3. 1 generation backK032679 Aequalis Shoulder Fracture SystemTornier · 2003
  4. This deviceK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
  5. Descendant · cites it directly · 257 of its ownK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
  6. Descendant · 2 generations on · 199 of its ownK061439 Aequalis Reversed ProsthesisTornier · 2006
  7. Descendant · 2 generations on · 179 of its ownK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008
  8. Descendant · 3 generations on · 178 of its ownK071948 Aequalis Reversed AdapterTornier · 2007
  9. Descendant · cites it directly · 164 of its ownK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008

Showing 5 of 258 descendants. See all descendants

Descendants cleared per year

2006: 52007: 22008: 32010: 52011: 102012: 72013: 82014: 112015: 62016: 122017: 142018: 172019: 202020: 182021: 222022: 222023: 172024: 162025: 212026: 22
2006high 22 (2021) · low 0 (2009)2026

Most influential descendants

Showing 5 of 258 · See all
  • K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006 · cites it directly257descendants
  • K061439Aequalis Reversed ProsthesisTornier · 2006 · 2 generations on199descendants
  • K081059Aequalis Reversed Shoulder ProsthesisTornier · 2008 · 2 generations on179descendants
  • K071948Aequalis Reversed AdapterTornier · 2007 · 3 generations on178descendants
  • K082120Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008 · cites it directly164descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K9203623M Modular Shoulder System3M Health Care, Ltd.1993—
−2K002683WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc2000—
−1K032679Aequalis Shoulder Fracture SystemTornier2003—
0 (this device)K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier2004—
+1K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier2006—
+2K061439Aequalis Reversed ProsthesisTornier2006—
+2K081059Aequalis Reversed Shoulder ProsthesisTornier2008—
+3K071948Aequalis Reversed AdapterTornier2007—
+1K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199510
199610
200020
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200650
200720
200830
201050
2011100
201270
201380
2014110
201560
2016120
2017140
2018170
2019200
2020180
2021220
2022220
2023170
2024160
2025210
2026220
FIG. 1 — Lineage of K043077, 1993–2026Source: 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), 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 KWS? 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 KWS device

  1. #1 K220847 AETOS Shoulder Systemscore 21.1 · 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? (7)

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
…r semi-constrained cemented prosthesis. 5) Equivalent / Predicate device For the AEQUALIS Shoulder Fracture System: AEQUALIS Shoulder system, TORNIER SA, K952928, K041339 AEQUALIS Shoulder Fracture system, TORNIER SA, K994392, K003728, K032679 Modular Shoulder System, Wright Medic…
Tornier1995—
*K041339Aequalis Shoulder System
Summary page 1
…nstrained cemented prosthesis. 5) Equivalent / Predicate device For the AEQUALIS Shoulder Fracture System: AEQUALIS Shoulder system, TORNIER SA, K952928, K041339 AEQUALIS Shoulder Fracture system, TORNIER SA, K994392, K003728, K032679 Modular Shoulder System, Wright Medical Techno…
Tornier2004—
*K994392Aequalis Shoulder Fracture System
Summary page 1
…te device For the AEQUALIS Shoulder Fracture System: AEQUALIS Shoulder system, TORNIER SA, K952928, K041339 AEQUALIS Shoulder Fracture system, TORNIER SA, K994392, K003728, K032679 Modular Shoulder System, Wright Medical Technology Inc, K002683 Select Shoulder System, Intermedics O…
Tornier2000—
*K003728Modification to Aequalis Shoulder Fracture System
Summary page 1
…For the AEQUALIS Shoulder Fracture System: AEQUALIS Shoulder system, TORNIER SA, K952928, K041339 AEQUALIS Shoulder Fracture system, TORNIER SA, K994392, K003728, K032679 Modular Shoulder System, Wright Medical Technology Inc, K002683 Select Shoulder System, Intermedics Orthopedic…
Tornier2000—
*K032679Aequalis Shoulder Fracture System
Summary page 1
…the AEQUALIS Shoulder Fracture System: AEQUALIS Shoulder system, TORNIER SA, K952928, K041339 AEQUALIS Shoulder Fracture system, TORNIER SA, K994392, K003728, K032679 Modular Shoulder System, Wright Medical Technology Inc, K002683 Select Shoulder System, Intermedics Orthopedics, K87367…
Tornier2003—
*K002683WMT Ultra-Fit Modular Shoulder System
Summary page 1
…, TORNIER SA, K952928, K041339 AEQUALIS Shoulder Fracture system, TORNIER SA, K994392, K003728, K032679 Modular Shoulder System, Wright Medical Technology Inc, K002683 Select Shoulder System, Intermedics Orthopedics, K873679…
Wrightmedicaltechnologyinc2000—
*K873679Select Shoulder System
Summary page 1
…system, TORNIER SA, K994392, K003728, K032679 Modular Shoulder System, Wright Medical Technology Inc, K002683 Select Shoulder System, Intermedics Orthopedics, K873679 Page I/page 2…
Intermedics Orthopedics1987—

Also cleared against K952928: 18 other devices →

What descends from it? (258)

See all 258

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

NumberDeviceApplicantDecidedDescendants
K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier2006257
K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164
K063081Aequalis Shoulder SystemTornier2006162
K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825
K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223
K062661Aequalis Resurfacing HeadTornier200616

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 11 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K060209 (Tornier, 2006) has gone furthest, with 257 descendants of its own.
  • 18 other devices also cite its predicate K952928.

How does its category compare?

All KWS devices

KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWS

3in 2025

2007: 22008: 42009: 42010: 72011: 112012: 72013: 122014: 72015: 82016: 102017: 72018: 42019: 92020: 32021: 52022: 52023: 42024: 22025: 32026 (partial year): 2
2007high 12 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWS

97in 2025

2008: 37 days median2009: 108 days median2010: 33 days median2011: 90 days median2012: 86 days median2013: 120 days median2014: 89 days median2015: 129 days median2016: 114 days median2017: 120 days median2018: 152 days median2019: 106 days median2020: 98 days median2021: 151 days median2022: 158 days median2023: 250 days median2025: 97 days median
2007high 250 (2023) · low 33 (2010)2026

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

Recalls per year · KWS

2in 2023

2007: 212008: 292010: 102011: 112012: 102014: 12016: 12017: 42018: 12019: 22020: 52023: 22026 (partial year): 1
2007high 29 (2008) · low 0 (2009)2026

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

Adverse event reports per year · KWS

2,281in 2025

2007: 1582008: 2382009: 2942010: 3932011: 4862012: 5422013: 8182014: 1,0662015: 1,1702016: 9702017: 1,6812018: 1,5452019: 1,7282020: 1,5672021: 1,3582022: 1,2682023: 1,7502024: 2,1222025: 2,281
2007high 2,281 (2025) · low 158 (2007)2025

MAUDE reports naming product code KWS, 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
20072—21158
200843729238
200941080294
201073310393
2011119011486
201278610542
2013121200818
201478911,066
2015812901,170
2016101141970
2017712041,681
2018415211,545
2019910621,728
202039851,567
2021515101,358
2022515801,268
2023425021,750
20242—02,122
202539702,281
20262—1—

What is it indicated for?

Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: - Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary and secondary necrosis of the humeral head - Displaced 4-part upper humeral fracture - Humeral head fracture - Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable - Revision surgery when other…

Read the full statement (103 words)

Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:

- Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis.

Primary and secondary necrosis of the humeral head

- Displaced 4-part upper humeral fracture

- Humeral head fracture

- Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable

- Revision surgery when other treatments or devices have failed.

Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures.

Revision surgery when other treatments or devices have failed.

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 KWS

The KWS category page

  • K260721Tornier Perform Advanced GlenoidTornier, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026
  • K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2025
  • K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc. · 2025
  • K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A. · 2025

https://510kreport.com/device/K043077 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043077: Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043077

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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