510(k) Report

510(k) · Cleared

Cleared

Aequalis Reversed Fracture Shoulder Prothesis

K082120510(k) TraditionalCleared Oct 24, 200888-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 Oct 24, 2008 as substantially equivalent to K030941 (Tornier, 2004) and 12 other predicates after an 88-day review. Its family tree reaches back 9 generations to 1991. 164 later devices descend from it.

Decided
Oct 24, 2008
Review
88 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
13

Its longest line of descent runs back 9 generations to K911686 (1991). 37 ancestors in all, the oldest K800494 (1980). 164 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 2 other ancestors2006: 3 other ancestors2004: 2 other ancestors2003: 2 other ancestors2000: 4 other ancestors2001: 3 other ancestors1999: 3 other ancestors1995: 1 other ancestor1987: 1 other ancestor2005: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor1993: 1 other ancestor1980: 2 other ancestors1992: 1 other ancestor2011: 4 descendants cleared2017: 10 descendants cleared2012: 2 descendants cleared2014: 10 descendants cleared2013: 5 descendants cleared2010: 1 descendant cleared2015: 4 descendants cleared2019: 13 descendants cleared2021: 16 descendants cleared2020: 14 descendants cleared2022: 18 descendants cleared2016: 4 descendants cleared2024: 10 descendants cleared2023: 14 descendants cleared2018: 11 descendants cleared2025: 14 descendants cleared2026: 14 descendants clearedK911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K021478 · Delta Shoulder · Depuy, Inc. · 2003×2: 2 generations cleared close together, K030941 (2004), K041873 (2004) K050316 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2005K061439 · Aequalis Reversed Prosthesis · Tornier · 2006K071948 · Aequalis Reversed Adapter · Tornier · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 10 other ancestors3 generations back: 7 other ancestors4 generations back: 4 other ancestors 1 generation forward: 9 descendants2 generations forward: 28 descendants3 generations forward: 42 descendants4 generations forward: 36 descendants5 generations forward: 28 descendants6 generations forward: 15 descendants7 generations forward: 5 descendants8 generations forward: 1 descendant K071948 · Aequalis Reversed Adapter · Tornier · 2007K061439 · Aequalis Reversed Prosthesis · Tornier · 2006K050316 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2005K041873 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K030941 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K021478 · Delta Shoulder · Depuy, Inc. · 2003K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991−50+5
  1. Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 5 generations between
  3. 3 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
  4. 2 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
  5. 1 generation backK071948 Aequalis Reversed AdapterTornier · 2007
  6. This deviceK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
  7. Descendant · cites it directly · 147 of its ownK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
  8. Descendant · cites it directly · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  9. Descendant · 2 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  10. Descendant · 3 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  11. Descendant · cites it directly · 59 of its ownK103208 Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P. · 2011
Show all 9 generations
  1. Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 8 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 7 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 6 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 5 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 4 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 3 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
  8. 2 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
  9. 1 generation backK071948 Aequalis Reversed AdapterTornier · 2007
  10. This deviceK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008

Showing 5 of 164 descendants. See all descendants

Descendants cleared per year

2010: 12011: 42012: 22013: 52014: 102015: 42016: 42017: 102018: 112019: 132020: 142021: 162022: 182023: 142024: 102025: 142026: 14
2010high 18 (2022) · low 1 (2010)2026

Most influential descendants

Showing 5 of 164 · See all
  • K100142Aequalis Reversed Shoulder ProsthesisTornier · 2010 · cites it directly147descendants
  • K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · cites it directly108descendants
  • K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on97descendants
  • K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · 3 generations on96descendants
  • K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P. · 2011 · cites it directly59descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−8K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−7K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−6K021478Delta ShoulderDepuy, Inc.2003—
−5K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−4K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−3K050316Aequalis Reversed Shoulder ProsthesisTornier2005—
−2K061439Aequalis Reversed ProsthesisTornier2006—
−1K071948Aequalis Reversed AdapterTornier2007—
0 (this device)K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008—
+1K100142Aequalis Reversed Shoulder ProsthesisTornier2010—
+1K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
+2K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
+3K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
+1K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198020
198710
199210
199310
199510
199610
199810
199930
200040
200130
200320
200420
200510
200630
200720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201140
201220
201350
2014100
201540
201640
2017100
2018110
2019130
2020140
2021160
2022180
2023140
2024100
2025140
2026140
FIG. 1 — Lineage of K082120, 1991–2026Source: 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? (13)

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
*K030941Aequalis Reversed Shoulder Prosthesis
Summary page 4
…ification Device class: Class 1! Classification panel: Orthopedic Product code: KWS 5) Equivalent/Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439. Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K043077, K060209. Delta Xte…
Tornier2004—
*K041873Aequalis Reversed Shoulder Prosthesis
Summary page 4
…Device class: Class 1! Classification panel: Orthopedic Product code: KWS 5) Equivalent/Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439. Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K043077, K060209. Delta Xtend Revers…
Tornier2004—
*K050316Aequalis Reversed Shoulder Prosthesis
Summary page 4
…class: Class 1! Classification panel: Orthopedic Product code: KWS 5) Equivalent/Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439. Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K043077, K060209. Delta Xtend Reverse Shoulde…
Tornier2005—
*K061439Aequalis Reversed Prosthesis
Summary page 4
…ass 1! Classification panel: Orthopedic Product code: KWS 5) Equivalent/Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439. Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K043077, K060209. Delta Xtend Reverse Shoulder System,…
Tornier2006—
*K994392Aequalis Shoulder Fracture System
Summary page 4
…WS 5) Equivalent/Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439. Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K043077, K060209. Delta Xtend Reverse Shoulder System, DEPUY, K062250, K071379. Delta Shoulder, DEPUY, K02147…
Tornier2000—
*K003728Modification to Aequalis Shoulder Fracture System
Summary page 4
…uivalent/Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439. Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K043077, K060209. Delta Xtend Reverse Shoulder System, DEPUY, K062250, K071379. Delta Shoulder, DEPUY, K021478 Aequal…
Tornier2000—
*K032679Aequalis Shoulder Fracture System
Summary page 4
…Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439. Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K043077, K060209. Delta Xtend Reverse Shoulder System, DEPUY, K062250, K071379. Delta Shoulder, DEPUY, K021478 Aequalis Revers…
Tornier2003—
*K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System
Summary page 4
…device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439. Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K043077, K060209. Delta Xtend Reverse Shoulder System, DEPUY, K062250, K071379. Delta Shoulder, DEPUY, K021478 Aequalis Reversed Adapte…
Tornier2004—
*K060209Aequalis Shoulder Fracture System & Aequalis Shoulder System
Summary page 4
…Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439. Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K043077, K060209. Delta Xtend Reverse Shoulder System, DEPUY, K062250, K071379. Delta Shoulder, DEPUY, K021478 Aequalis Reversed Adapter, TORNIE…
Tornier2006—
*K062250Delta Xtend Reverse Shoulder System
Summary page 4
…30941, K041873, K050316, K061439. Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K043077, K060209. Delta Xtend Reverse Shoulder System, DEPUY, K062250, K071379. Delta Shoulder, DEPUY, K021478 Aequalis Reversed Adapter, TORNIER SA, K071943 Page 1/ page 3 TORNIER S.A.S. Tél : 3…
DePuy Orthopaedics, Inc.20078
*K071379Delta Xtend Reverse Shoulder Modular Stem
Summary page 4
…41873, K050316, K061439. Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K043077, K060209. Delta Xtend Reverse Shoulder System, DEPUY, K062250, K071379. Delta Shoulder, DEPUY, K021478 Aequalis Reversed Adapter, TORNIER SA, K071943 Page 1/ page 3 TORNIER S.A.S. Tél : 33 (04 76…
DePuy Orthopaedics, Inc.2007—
*K021478Delta Shoulder
Summary page 4
…Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K043077, K060209. Delta Xtend Reverse Shoulder System, DEPUY, K062250, K071379. Delta Shoulder, DEPUY, K021478 Aequalis Reversed Adapter, TORNIER SA, K071943 Page 1/ page 3 TORNIER S.A.S. Tél : 33 (04 76 61 35 00 S.A.S. au capital de 288…
Depuy, Inc.2003—
*K071948Aequalis Reversed Adapter
Our OCR of the scanned summary read K071943, FDA’s number for Serenity Pro PSF System (Inolase 2002, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Aequalis Reversed Adapter”.
Tornier2007—

Also cleared against K030941: 16 other devices →

What descends from it? (164)

See all 164

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

NumberDeviceApplicantDecidedDescendants
K100142Aequalis Reversed Shoulder ProsthesisTornier2010147
K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108
K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159
K120174Deput Delta Xtend Reverse ShoulderDepuy France201241
K141990Encore Humeral Shoulder StemEncore Medical L.P.201419
K162455Humelock Reversed ShoulderFx Solutions201717
K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212
K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135
K141345Aequalis FX2Tornier S.A.S.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?

  • The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
  • 6 of the 37 ancestors have a recall of any class.
  • Of its descendants, K100142 (Tornier, 2010) has gone furthest, with 147 descendants of its own.
  • 16 other devices also cite its predicate K030941.

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. 2008, this device’s year, is highlighted.

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?

The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint: - in case of 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…

Read the full statement (263 words)

The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint:

- in case of 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, or

- in case of bone defect in proximal humerus.

The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed Fracture Shoulder Prosthesis, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis.

The Aequalis Reversed Fracture Shoulder humeral stem is for cemented 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 K030941

16 other devices cite the same predicate.

  • K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland) · 2019
  • K162455Humelock Reversed ShoulderFx Solutions · 2017
  • K152966Aequalis Fx2Tornier S.A.S. · 20161 recall
  • K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2015
  • K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2014
  • K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013

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/K082120 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082120: Aequalis Reversed Fracture Shoulder Prothesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082120

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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