510(k) Report

510(k) · Cleared

Cleared

Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

K253592510(k) TraditionalCleared Apr 13, 2026147-day reviewClass II21 CFR 888.3670

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

Zimmer, Inc. · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Apr 13, 2026 as substantially equivalent to K240876 (Zimmer, Inc., 2024) and 5 other predicates after a 147-day review. Its family tree reaches back 19 generations to 1991. 1 of the 174 devices in its family, counting itself, has a Class I recall.

Decided
Apr 13, 2026
Review
147 days
Class
Class II
Product code
MBF
Recalls
None
Predicates
6

Its longest line of descent runs back 19 generations to K911686 (1991). 173 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 174 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2024: 1 other ancestor2020: 3 other ancestors2018: 1 other ancestor2012: 8 other ancestors2022: 2 other ancestors2016: 2 other ancestors2014: 4 other ancestors2013: 4 other ancestors2011: 5 other ancestors2009: 2 other ancestors2006: 14 other ancestors2005: 8 other ancestors2010: 3 other ancestors2008: 8 other ancestors2007: 7 other ancestors2004: 3 other ancestors2003: 6 other ancestors2002: 4 other ancestors1999: 6 other ancestors1996: 8 other ancestors1995: 4 other ancestors2001: 9 other ancestors2000: 10 other ancestors1998: 6 other ancestors1997: 3 other ancestors1994: 6 other ancestors1992: 2 other ancestors1987: 5 other ancestors1993: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor1980: 2 other ancestors1979: 1 other ancestor1991: 3 other ancestors1988: 1 other ancestorK911686 · 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 · recalledK132285 · Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2013K151293 · Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2015K190521 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2019K201315 · PERFORM Humeral System – Stem · Tornier, Inc. · 2020 · recalledK240876 · Identity Shoulder System · Zimmer, Inc. · 202419801990200020102020
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 16 other ancestors3 generations back: 18 other ancestors4 generations back: 36 other ancestors5 generations back: 42 other ancestors6 generations back: 21 other ancestors7 generations back: 5 other ancestors8 generations back: 5 other ancestors9 generations back: 5 other ancestors10 generations back: 1 other ancestor K240876 · Identity Shoulder System · Zimmer, Inc. · 2024K201315 · PERFORM Humeral System – Stem · Tornier, Inc. · 2020 · recalledK190521 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2019K151293 · Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2015K132285 · Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2013K122698 · 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. · 1991−15−10−50
  1. Root · 19 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 15 generations between
  3. 3 generations backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
  4. 2 generations backK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
  5. 1 generation backK240876 Identity Shoulder SystemZimmer, Inc. · 2024
  6. This deviceK253592 Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral…Zimmer, Inc. · 2026
Show all 19 generations
  1. Root · 19 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 18 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 17 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 16 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 15 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 14 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 13 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 12 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 11 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 10 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 9 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 8 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. 7 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  14. 6 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  15. 5 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
  16. 4 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
  17. 3 generations backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
  18. 2 generations backK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
  19. 1 generation backK240876 Identity Shoulder SystemZimmer, Inc. · 2024
  20. This deviceK253592 Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral…Zimmer, Inc. · 2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder2 generations back · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−18K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−17K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−16K021478Delta ShoulderDepuy, Inc.2003—
−15K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−14K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−13K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−12K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−11K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−10K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−9K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−8K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−7K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−6K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
−5K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2013—
−4K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2015—
−3K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2019—
−2K201315PERFORM Humeral System – StemTornier, Inc.20201
−1K240876Identity Shoulder SystemZimmer, Inc.2024—
0 (this device)K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity…Zimmer, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198750
198810
198910
199130
199220
199310
199460
199540
199680
199730
199860
199960
2000100
200190
200240
200360
200430
200580
2006140
200770
200880
200920
201030
201150
201280
201340
201440
201620
201810
202030
202220
202410
FIG. 1 — Lineage of K253592, 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.

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 MBF device

  1. #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 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? (6)

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
*K240876Identity Shoulder System
Summary page 5
…de(s) MBF, KWT, KWS, HSD, PHX | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K240876 Identity Shoulder System MBF K193373 Comprehensive Reverse Shoulder PHX K181611 Comprehensive Reverse(Mini) Shoulder System PHX K…
Zimmer, Inc.2024—
*K193373Comprehensive® Reverse Shoulder
Summary page 5
…lly Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K240876 Identity Shoulder System MBF K193373 Comprehensive Reverse Shoulder PHX K181611 Comprehensive Reverse(Mini) Shoulder System PHX K121543 Zimmer Trabecular Metal Revers…
Biomet, Inc.20202
*K181611Comprehensive Reverse Shoulder System
Summary page 5
…2(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K240876 Identity Shoulder System MBF K193373 Comprehensive Reverse Shoulder PHX K181611 Comprehensive Reverse(Mini) Shoulder System PHX K121543 Zimmer Trabecular Metal Reverse Shoulder System KWT K233481 Altivate Reve…
Biomet Manufacturing Corp2018—
*K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral Stems
Summary page 5
…ate is listed first) Product Code K240876 Identity Shoulder System MBF K193373 Comprehensive Reverse Shoulder PHX K181611 Comprehensive Reverse(Mini) Shoulder System PHX K121543 Zimmer Trabecular Metal Reverse Shoulder System KWT K233481 Altivate Reverse Glenoid PHX K200209 Persona Personalized Knee System…
Zimmer, Inc.2012—
*K233481AltiVate Reverse® Glenoid
Summary page 5
…System MBF K193373 Comprehensive Reverse Shoulder PHX K181611 Comprehensive Reverse(Mini) Shoulder System PHX K121543 Zimmer Trabecular Metal Reverse Shoulder System KWT K233481 Altivate Reverse Glenoid PHX K200209 Persona Personalized Knee System JWH Device Description Summary 21 CFR 807.92(a)(4) This su…
Encore Medical L.P.20248
*K200209Persona Personalized Knee System
Summary page 5
…rse Shoulder PHX K181611 Comprehensive Reverse(Mini) Shoulder System PHX K121543 Zimmer Trabecular Metal Reverse Shoulder System KWT K233481 Altivate Reverse Glenoid PHX K200209 Persona Personalized Knee System JWH Device Description Summary 21 CFR 807.92(a)(4) This submission is seeking approval of Allia…
Zimmer, Inc.2020—

What descends from it?

No later submission names this one as a predicate yet.

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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 35 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
  • 52 of the 173 ancestors have a recall of any class; 1 has a Class I recall.

How does its category compare?

All MBF devices

MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · MBF

2in 2025

2007: 22008: 12009: 12012: 22013: 12014: 12017: 22018: 12019: 22020: 22021: 12022: 42023: 42024: 22025: 22026 (partial year): 1
2007high 4 (2022) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBF

144in 2023

2022: 164 days median2023: 144 days median
2007high 164 (2022) · low 144 (2023)2026

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

Recalls per year · MBF

1in 2023

2009: 12017: 12018: 12019: 22022: 82023: 1
2007high 8 (2022) · low 0 (2007)2026

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

Adverse event reports per year · MBF

255in 2025

2007: 22008: 72009: 162010: 242011: 322012: 302013: 402014: 282015: 492016: 852017: 1932018: 992019: 472020: 242021: 362022: 1142023: 1432024: 1642025: 255
2007high 255 (2025) · low 2 (2007)2025

MAUDE reports naming product code MBF, 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—02
20081—07
20091—116
20100—024
20110—032
20122—030
20131—040
20141—028
20150—049
20160—085
20172—1193
20181—199
20192—247
20202—024
20211—036
202241648114
202341441143
20242—0164
20252—0255
20261—0—

What is it indicated for?

Zimmer Biomet Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision…

Read the full statement (154 words)

Zimmer Biomet Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The titanium Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium Glenospheres is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The humeral components are indicated for either cemented or uncemented (biological fixation).

Compatible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

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

More from Zimmer, Inc.

524 FDA decisions under this applicant name. See the company

  • P060037/S100NexGen® LPS-Flex/LPS Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • K262955OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
  • P060037/S099NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • P060037/S097Creep Pressure Test Update for the Nexgen LPS Bearing KneeZimmer, Inc. · 2026
  • P060037/S098Nexgen LPS Femoral and Tibial Knee componentsZimmer, Inc. · 2026

Recent decisions in MBF

The MBF category page

  • K251098Identity Revision Humeral StemsZimmer, Inc. · 2025
  • K250848Identity Shoulder SystemZimmer, Inc. · 2025
  • K240876Identity Shoulder SystemZimmer, Inc. · 2024
  • K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. · 2024
  • K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2023

https://510kreport.com/device/K253592 · printed Nov 4, 2026

Cite this page

510(k) Report. “K253592: Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253592

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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