510(k) · Cleared
ClearedIdentity Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Jun 12, 2024 as substantially equivalent to K213856 (Zimmer, Inc., 2022) and 3 other predicates after a 75-day review. Its family tree reaches back 18 generations to 1991. 1 of the 151 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jun 12, 2024
- Review
- 75 days
- Class
- Class II
- Product code
- MBF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 18 generations to K911686 (1991). 149 ancestors in all, the oldest K790987 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 151 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 14 generations between
- 3 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- 2 generations backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- 1 generation backK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
- This deviceK240876 Identity Shoulder SystemZimmer, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253592 Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral…Zimmer, Inc. · 2026
Show all 18 generations
- Root · 18 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 17 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 16 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 15 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 14 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 13 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 12 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 11 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 10 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 9 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 8 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 7 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 6 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 5 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 4 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- 3 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- 2 generations backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- 1 generation backK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
- This deviceK240876 Identity Shoulder SystemZimmer, Inc. · 2024
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −17 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −16 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −15 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −14 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −13 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −12 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −11 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −10 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −9 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −8 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −7 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −6 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −5 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −4 | K132285 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2013 | — |
| −3 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015 | — |
| −2 | K190521 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2019 | — |
| −1 | K201315 | PERFORM Humeral System – Stem | Tornier, Inc. | 2020 | 1 |
| 0 (this device) | K240876 | Identity Shoulder System | Zimmer, Inc. | 2024 | — |
| +1 | K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity… | Zimmer, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 9 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 7 | 0 |
| 2006 | 12 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K213856 | Identity Shoulder SystemSummary page 5…MBF, KWT, KWS, HSD, PHX, PAO I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K213856 Identity Shoulder System MBF K201315 PERFORM Humeral System — Stem PAO K220914 Tornier Perform Humeral System — Fracture PHX K181… | 2022 |
| * | K201315 | PERFORM Humeral System – StemSummary page 5…lly Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K213856 Identity Shoulder System MBF K201315 PERFORM Humeral System — Stem PAO K220914 Tornier Perform Humeral System — Fracture PHX K181611 Comprehensive Reverse Shoulder Sy… | 2020 |
| * | K220914 | Tornier Perform Humeral System – FractureSummary page 5…92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K213856 Identity Shoulder System MBF K201315 PERFORM Humeral System — Stem PAO K220914 Tornier Perform Humeral System — Fracture PHX K181611 Comprehensive Reverse Shoulder System PHX Device Description Summary 21 CFR… | 2022 |
| * | K181611 | Comprehensive Reverse Shoulder SystemSummary page 5…dicate is listed first) Product Code K213856 Identity Shoulder System MBF K201315 PERFORM Humeral System — Stem PAO K220914 Tornier Perform Humeral System — Fracture PHX K181611 Comprehensive Reverse Shoulder System PHX Device Description Summary 21 CFR 807.92(a)(4) The Identity Shoulder System cleared pr… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral… | 2026 | 0 |
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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 35 of the 149 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K253592 (Zimmer, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K213856.
How does its category compare?
All MBF devicesMBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MBF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBF
144in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBF
255in 2025
MAUDE reports naming product code MBF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 1 | — | 1 | 16 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 1 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 49 |
| 2016 | 0 | — | 0 | 85 |
| 2017 | 2 | — | 1 | 193 |
| 2018 | 1 | — | 1 | 99 |
| 2019 | 2 | — | 2 | 47 |
| 2020 | 2 | — | 0 | 24 |
| 2021 | 1 | — | 0 | 36 |
| 2022 | 4 | 164 | 8 | 114 |
| 2023 | 4 | 144 | 1 | 143 |
| 2024 | 2 | — | 0 | 164 |
| 2025 | 2 | — | 0 | 255 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Hemiarthoplasty/Conventional Total Application: * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. * Rheumatoid arthritis. * Correction of functional deformity. * Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. * Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Optional use in…
Read the full statement (258 words)
Hemiarthoplasty/Conventional Total Application:
* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
* Rheumatoid arthritis.
* Correction of functional deformity.
* Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
* Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Reverse Application:
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 assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).
The Titanium Humeral Head and 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 humeral head or Glenospheres is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240876 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240876: Identity 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/K240876
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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