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 Sep 15, 2022 as substantially equivalent to K193038 (Biomet Manufacturing Corp, 2020) after a 279-day review. Its family tree reaches back 6 generations to 1980. 4 later devices descend from it.
- Decided
- Sep 15, 2022
- Review
- 279 days
- Class
- Class II
- Product code
- MBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K800494 (1980). 26 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 5 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 4 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 3 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- 2 generations backK060692 Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · Recalled
- 1 generation backK193038 Comprehensive Shoulder SystemBiomet Manufacturing Corp · 2020 · Recalled
- This deviceK213856 Identity Shoulder SystemZimmer, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK240876 Identity Shoulder SystemZimmer, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK253592 Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral…Zimmer, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251098 Identity Revision Humeral StemsZimmer, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK250848 Identity Shoulder SystemZimmer, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K240876Identity Shoulder SystemZimmer, Inc. · 2024 · cites it directly1descendant
- K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc. · 2026 · 2 generations on0descendants
- K251098Identity Revision Humeral StemsZimmer, Inc. · 2025 · cites it directly0descendants
- K250848Identity Shoulder SystemZimmer, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −5 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −4 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −3 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| −2 | K060692 | Comprehensive Primary Shoulder Stems | Biomet Manufacturing Corp | 2006 | 6 |
| −1 | K193038 | Comprehensive Shoulder System | Biomet Manufacturing Corp | 2020 | 1 |
| 0 (this device) | K213856 | Identity Shoulder System | Zimmer, Inc. | 2022 | — |
| +1 | K240876 | Identity Shoulder System | Zimmer, Inc. | 2024 | — |
| +2 | K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity… | Zimmer, Inc. | 2026 | — |
| +1 | K251098 | Identity Revision Humeral Stems | Zimmer, Inc. | 2025 | — |
| +1 | K250848 | Identity Shoulder System | Zimmer, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 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.
Planning a device in MBF? 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? (1)
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 |
|---|---|---|---|
| * | K193038 | Comprehensive Shoulder SystemSummary page 5…cemented prosthesis (21 CFR 888.3660) Predicate Device(s): Primary Predicate Device K193038 Comprehensive Shoulder System Reference Devices K… | 2020 |
| † | K193373 | Comprehensive® Reverse Shoulder | 2020 |
| † | K181611 | Comprehensive Reverse Shoulder System | 2018 |
| † | K193099 | Anatomical Shoulder System | 2020 |
| † | K103404 | ANA0TOMICAL Shoulder TM Combined System | 2011 |
| † | K840643 | Harris-Galante Porous Total Hip Sys | 1984 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 42 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 6 of the 26 ancestors have a recall of any class.
- Of its descendants, K240876 (Zimmer, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K193038.
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. 2022, 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 (257 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 not recommended for patients who lack suspected material sensitivity to cobalt alloy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213856: Identity Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213856
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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