510(k) · Cleared
ClearedIdentity Revision Humeral Stems
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 Aug 11, 2025 as substantially equivalent to K213856 (Zimmer, Inc., 2022) and 1 other predicate after a 123-day review. Its family tree reaches back 7 generations to 1980.
- Decided
- Aug 11, 2025
- Review
- 123 days
- Class
- Class II
- Product code
- MBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K800494 (1980). 27 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 6 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 5 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 4 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- 3 generations backK060692 Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · Recalled
- 2 generations backK193038 Comprehensive Shoulder SystemBiomet Manufacturing Corp · 2020 · Recalled
- 1 generation backK213856 Identity Shoulder SystemZimmer, Inc. · 2022
- This deviceK251098 Identity Revision Humeral StemsZimmer, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −6 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −5 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −4 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| −3 | K060692 | Comprehensive Primary Shoulder Stems | Biomet Manufacturing Corp | 2006 | 6 |
| −2 | K193038 | Comprehensive Shoulder System | Biomet Manufacturing Corp | 2020 | 1 |
| −1 | K213856 | Identity Shoulder System | Zimmer, Inc. | 2022 | — |
| 0 (this device) | K251098 | Identity Revision Humeral Stems | 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 |
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? (2)
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…de(s) MBF, KWT, KWS, HSD, PHX 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, KWT, K K193038 Comprehensive Shoulder System MBF, KWT, i§ Device Description Summary 21 CFR 807.92(… | 2022 |
| * | K193038 | Comprehensive Shoulder SystemSummary page 5…eted Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K213856 Identity Shoulder System MBF, KWT, K K193038 Comprehensive Shoulder System MBF, KWT, i§ Device Description Summary 21 CFR 807.92(a)(4) The Identity Revision Humeral Stems ar… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 45 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 6 of the 27 ancestors have a recall of any class.
- 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. 2025, 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 (208 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:
Identity Revision Humeral Stem 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 Identity Revision Humeral Stem 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).
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/K251098 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251098: Identity Revision Humeral Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251098
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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