510(k) Report

510(k) · Cleared

Cleared

Aequalis Reversed Shoulder Prosthesis

K132285510(k) TraditionalCleared Dec 5, 2013135-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 S.A.S. · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Dec 5, 2013 as substantially equivalent to K030941 (Tornier, 2004) and 8 other predicates after a 135-day review. Its family tree reaches back 14 generations to 1991. 1 of the 128 devices in its family, counting itself, has a Class I recall. 26 later devices descend from it.

Decided
Dec 5, 2013
Review
135 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
9

Its longest line of descent runs back 14 generations to K911686 (1991). 101 ancestors in all, the oldest K790987 (1979). 26 later devices descend from it, 4 citing it directly. 1 of the 128 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 2 other ancestors2008: 4 other ancestors2006: 9 other ancestors2005: 6 other ancestors2012: 3 other ancestors2007: 5 other ancestors2004: 3 other ancestors2001: 7 other ancestors1999: 5 other ancestors1995: 2 other ancestors2003: 6 other ancestors2000: 6 other ancestors1996: 5 other ancestors1980: 2 other ancestors2011: 1 other ancestor1998: 3 other ancestors1987: 5 other ancestors2002: 1 other ancestor1997: 1 other ancestor1993: 1 other ancestor1992: 2 other ancestors1994: 1 other ancestor1991: 2 other ancestors1988: 1 other ancestor1979: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor2015: 1 descendant cleared2023: 4 descendants cleared2017: 1 descendant cleared2018: 1 descendant cleared2019: 2 descendants cleared2024: 6 descendants cleared2020: 1 descendant cleared2025: 5 descendants cleared2026: 3 descendants cleared2022: 2 descendants clearedK911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991×2: 2 generations cleared close together, K984541 (1999), K992065 (1999) ×3: 3 generations cleared close together, K021478 (2003), K030941 (2004), K041873 (2004) ×2: 2 generations cleared close together, K052906 (2005), K060704 (2006) K063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalled×2: 2 generations cleared close together, K073688 (2008), K080642 (2008) ×2: 2 generations cleared close together, K110599 (2011), K112615 (2011) K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 10 other ancestors3 generations back: 13 other ancestors4 generations back: 8 other ancestors5 generations back: 12 other ancestors6 generations back: 25 other ancestors7 generations back: 3 other ancestors8 generations back: 8 other ancestors9 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 7 descendants4 generations forward: 6 descendants5 generations forward: 4 descendants K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalledK112615 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K110599 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K080642 · Comprehensive Reverse Shoulder · Biomet, Inc. · 2008 · Class I recallK073688 · Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw · Exactech, Inc. · 2008 · recalledK063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalledK060704 · Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM · Zimmer, Inc. · 2006 · recalledK052906 · Zimmer Trabecular Metal Reverse Shoulder System · Zimmer, Inc. · 2005 · recalledK041873 · 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. · 1991−10−50+5
  1. Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 10 generations between
  3. 3 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  4. 2 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  5. 1 generation backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  6. This deviceK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
  7. Descendant · cites it directly · 20 of its ownK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
  8. Descendant · 2 generations on · 12 of its ownK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
  9. Descendant · 3 generations on · 11 of its ownK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
  10. Descendant · 2 generations on · 5 of its ownK220847 AETOS Shoulder SystemSmith & Nephew, Inc. · 2023
  11. Descendant · 3 generations on · 3 of its ownK240716 AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. · 2024
Show all 14 generations
  1. Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 8 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 7 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 6 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 5 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 4 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 3 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. 2 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  14. 1 generation backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  15. This deviceK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2015: 12017: 12018: 12019: 22020: 12022: 22023: 42024: 62025: 52026: 3
2015high 6 (2024) · low 0 (2016)2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder4 generations back · 2008

Most influential descendants

Showing 5 of 26 · See all
  • K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2015 · cites it directly20descendants
  • K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019 · 2 generations on12descendants
  • K201315PERFORM Humeral System – StemTornier, Inc. · 2020 · 3 generations on11descendants
  • K220847AETOS Shoulder SystemSmith & Nephew, Inc. · 2023 · 2 generations on5descendants
  • K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. · 2024 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−13K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−12K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−11K021478Delta ShoulderDepuy, Inc.2003—
−10K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−9K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−8K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−7K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−6K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−5K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−4K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−2K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−1K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
0 (this device)K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2013—
+1K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2015—
+2K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2019—
+3K201315PERFORM Humeral System – StemTornier, Inc.20201
+2K220847AETOS Shoulder SystemSmith & Nephew, Inc.2023—
+3K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198750
198810
198910
199120
199220
199310
199410
199520
199650
199710
199830
199950
200060
200170
200210
200360
200430
200560
200690
200750
200840
200920
201010
201110
201230

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201710
201810
201920
202010
202220
202340
202460
202550
202630
FIG. 1 — Lineage of K132285, 1991–2026Source: 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.

1 device in this family has a Class I recall. 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 PHX device

  1. #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 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? (9)

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
…ication Device class: Class I Classification panel: Orthopedic Predact code: KWS §) Equivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SAS, K030941, K050316, K061439. K081059, K100142 . ’ Acqualis Ascend Flex Shoulder, TORNIER SAS. K122698 Reverse Shoulder Prosthesis. DJO SU…
Tornier2004—
*K050316Aequalis Reversed Shoulder Prosthesis
Summary page 4
…Device class: Class I Classification panel: Orthopedic Predact code: KWS §) Equivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SAS, K030941, K050316, K061439. K081059, K100142 . ’ Acqualis Ascend Flex Shoulder, TORNIER SAS. K122698 Reverse Shoulder Prosthesis. DJO SURGICAL, K…
Tornier2005—
*K061439Aequalis Reversed Prosthesis
Summary page 4
…ass: Class I Classification panel: Orthopedic Predact code: KWS §) Equivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SAS, K030941, K050316, K061439. K081059, K100142 . ’ Acqualis Ascend Flex Shoulder, TORNIER SAS. K122698 Reverse Shoulder Prosthesis. DJO SURGICAL, K041066, K…
Tornier2006—
*K081059Aequalis Reversed Shoulder Prosthesis
Summary page 4
…s I Classification panel: Orthopedic Predact code: KWS §) Equivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SAS, K030941, K050316, K061439. K081059, K100142 . ’ Acqualis Ascend Flex Shoulder, TORNIER SAS. K122698 Reverse Shoulder Prosthesis. DJO SURGICAL, K041066, K051075, K…
Tornier2008—
*K100142Aequalis Reversed Shoulder Prosthesis
Summary page 4
…ification panel: Orthopedic Predact code: KWS §) Equivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SAS, K030941, K050316, K061439. K081059, K100142 . ’ Acqualis Ascend Flex Shoulder, TORNIER SAS. K122698 Reverse Shoulder Prosthesis. DJO SURGICAL, K041066, K051075, K092873 6…
Tornier2010—
*K122698Aequalis Ascend Flex Shoulder System
Summary page 4
…lent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SAS, K030941, K050316, K061439. K081059, K100142 . ’ Acqualis Ascend Flex Shoulder, TORNIER SAS. K122698 Reverse Shoulder Prosthesis. DJO SURGICAL, K041066, K051075, K092873 6) Device description The Aequalis Reversed Shoulder Pros…
Tornier S.A.S.20132
*K041066Encore Reverse Shoulder Prosthesis
Summary page 4
…Prosthesis, TORNIER SAS, K030941, K050316, K061439. K081059, K100142 . ’ Acqualis Ascend Flex Shoulder, TORNIER SAS. K122698 Reverse Shoulder Prosthesis. DJO SURGICAL, K041066, K051075, K092873 6) Device description The Aequalis Reversed Shoulder Prosthesis is intended to be used to relieve pain and si…
Encore Medical L.P.20054
*K051075Encore Reverse Shoulder Prosthesis
Summary page 4
…s, TORNIER SAS, K030941, K050316, K061439. K081059, K100142 . ’ Acqualis Ascend Flex Shoulder, TORNIER SAS. K122698 Reverse Shoulder Prosthesis. DJO SURGICAL, K041066, K051075, K092873 6) Device description The Aequalis Reversed Shoulder Prosthesis is intended to be used to relieve pain and significant…
Encore Medical L.P.20055
*K092873Reverse Shoulder Prosthesis
Summary page 4
…R SAS, K030941, K050316, K061439. K081059, K100142 . ’ Acqualis Ascend Flex Shoulder, TORNIER SAS. K122698 Reverse Shoulder Prosthesis. DJO SURGICAL, K041066, K051075, K092873 6) Device description The Aequalis Reversed Shoulder Prosthesis is intended to be used to relieve pain and significant disabili…
Djo Surgical2009—

Also cleared against K030941: 16 other devices →

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520
K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183
K232226ARROW Off-Centred Humeral InsertFH Industrie20230
K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 22 years and passes through 8 companies; a new generation was cleared every 11 months on median.
  • 25 of the 101 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K151293 (Tornier S.A.S., 2015) has gone furthest, with 20 descendants of its own.
  • 16 other devices also cite its predicate K030941.

How does its category compare?

All PHX devices

PHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · PHX

9in 2025

2007: 52008: 62009: 12010: 82011: 122012: 122013: 82014: 122015: 42016: 42017: 112018: 142019: 92020: 132021: 212022: 92023: 92024: 92025: 92026 (partial year): 18
2007high 21 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PHX

72in 2025

2007: 97 days median2008: 79 days median2010: 124 days median2011: 94 days median2012: 114 days median2013: 143 days median2014: 110 days median2015: 206 days median2016: 132 days median2017: 141 days median2018: 127 days median2019: 144 days median2020: 143 days median2021: 143 days median2022: 198 days median2023: 154 days median2024: 139 days median2025: 72 days median2026 (partial year): 130 days median
2007high 206 (2015) · low 72 (2025)2026

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

Recalls per year · PHX

3in 2025

2015: 22018: 12019: 32020: 32021: 82023: 72024: 12025: 32026 (partial year): 7
2007high 8 (2021) · low 0 (2007)2026

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

Adverse event reports per year · PHX

2,848in 2025

2015: 142016: 52017: 252018: 3232019: 5042020: 9862021: 1,4042022: 1,3422023: 1,4012024: 2,1422025: 2,848
2007high 2,848 (2025) · low 0 (2007)2025

MAUDE reports naming product code PHX, 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
200759700
200867900
20091—00
2010812400
2011129400
20121211400
2013814300
20141211000
20154206214
2016413205
201711141025
2018141271323
201991443504
2020131433986
20212114381,404
2022919801,342
2023915471,401
2024913912,142
202597232,848
2026181307—

What is it indicated for?

Cemented Aequalis Reversed -prosthesis: It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is…

Read the full statement (397 words)

Cemented Aequalis Reversed -prosthesis:

It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

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 hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

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

Uncemented Aequalis Reversed prosthesis:

It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

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

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

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
  • K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture…Tornier · 2012

More from Tornier S.A.S.

20 FDA decisions under this applicant name. See the company

  • K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024
  • K222510Blueprint Mixed Reality systemTornier S.A.S. · 202310 recalls
  • DEN220012Tornier Pyrocarbon Humeral HeadTornier S.A.S. · 2022
  • K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
  • K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019

Recent decisions in PHX

The PHX category page

  • K263421Veritas Shoulder Systemrestor3d, inc. · 2026
  • K263086AltiVate Reverse® Glenosphere with RAVN™ TechnologyEncore Medical L.P. · 2026
  • K260556Veritas Shoulder SystemRestor3D · 2026
  • K261683Augment Off-Axis Instrument SystemZimmer, Inc. · 2026
  • K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.) · 2026

https://510kreport.com/device/K132285 · printed Nov 4, 2026

Cite this page

510(k) Report. “K132285: Aequalis Reversed Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132285

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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