510(k) · Cleared
ClearedHumeral Short Stem System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shoulder Innovations, Inc. · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Oct 23, 2018 as substantially equivalent to K060692 (Biomet Manufacturing Corp, 2006) after a 309-day review. Its family tree reaches back 5 generations to 1980. 3 later devices descend from it.
- Decided
- Oct 23, 2018
- Review
- 309 days
- Class
- Class II
- Product code
- MBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K800494 (1980). 25 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 4 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 3 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 2 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- 1 generation backK060692 Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · Recalled
- This deviceK173824 Humeral Short Stem SystemShoulder Innovations, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK192365 Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK241817 InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK262173 N22 Offset Humeral HeadShoulder Innovations, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See all- K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc. · 2019 · cites it directly2descendants
- K241817InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025 · 2 generations on1descendant
- K262173N22 Offset Humeral HeadShoulder Innovations, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −4 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −3 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −2 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| −1 | K060692 | Comprehensive Primary Shoulder Stems | Biomet Manufacturing Corp | 2006 | 6 |
| 0 (this device) | K173824 | Humeral Short Stem System | Shoulder Innovations, Inc. | 2018 | — |
| +1 | K192365 | Shoulder Innovations Total Shoulder System | Shoulder Innovations, Inc. | 2019 | — |
| +2 | K241817 | InSet Total Shoulder System | Shoulder Innovations, Inc. | 2025 | — |
| +3 | K262173 | N22 Offset Humeral Head | Shoulder Innovations, Inc. | 2026 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K060692 | Comprehensive Primary Shoulder StemsSummary page 4…ction 888.3690 – Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. Product Code: HSD Substantially K060692, Biomet Comprehensive® Primary Shoulder Equivalent Device: Stems… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192365 | Shoulder Innovations Total Shoulder System | 2019 | 2 |
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 38 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 25 ancestors have a recall of any class.
- Of its descendants, K192365 (Shoulder Innovations, Inc., 2019) has gone furthest, with 2 descendants of its own.
- 14 other devices also cite its predicate K060692.
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. 2018, 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?
The Shoulder Innovations Total Shoulder System is intended for use as an
orthopedic implant for partial or total shoulder arthroplasty to treat the following:
1. significant disability in degenerative, rheumatoid, or traumatic disease of the
glenohumeral joint;
2. avascular necrosis of the humeral head.
The assembled humeral component may be used alone for hemiarthroplasty or
combined with the glenoid component for total shoulder arthroplasty.
The Total Shoulder System components are intended for single use only. The
glenoid component is intended for cemented fixation only; the humeral stem may
be implanted by press-fit or cement fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173824: Humeral Short Stem System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173824
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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