510(k) · Cleared
ClearedArthrex Univers Apex, Size 5 Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Nov 23, 2015 as substantially equivalent to K131633 (Arthrex, Inc., 2013) and 1 other predicate after a 26-day review. Its family tree reaches back 6 generations to 1980. 2 later devices descend from it.
- Decided
- Nov 23, 2015
- Review
- 26 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K800494 (1980). 29 ancestors in all. 2 later devices descend from it, 1 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 backK131633 Arthrex Univers ApexArthrex, Inc. · 2013
- This deviceK153115 Arthrex Univers Apex, Size 5 StemArthrex, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK171841 Arthrex Shoulder SystemArthrex, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK230366 Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView 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 | K131633 | Arthrex Univers Apex | Arthrex, Inc. | 2013 | — |
| 0 (this device) | K153115 | Arthrex Univers Apex, Size 5 Stem | Arthrex, Inc. | 2015 | — |
| +1 | K171841 | Arthrex Shoulder System | Arthrex, Inc. | 2018 | — |
| +2 | K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33 | Arthrex, Inc. | 2023 | — |
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 | 2 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 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 KWS? 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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 |
|---|---|---|---|
| * | K131633 | Arthrex Univers ApexSummary page 4…888.3660 HSD – Prosthesis, Shoulder, Hemi-Humeral, Metal, Uncemented, CFR 888.3690 Predicate Device K131633: Arthrex Univers Apex Stems K103466: Arthrex Size 5 Univers II Stems Purpose of Submission… | 2013 |
| * | K103466 | Arthrex Univers II Shoulder ProsthesisSummary page 4…er, Hemi-Humeral, Metal, Uncemented, CFR 888.3690 Predicate Device K131633: Arthrex Univers Apex Stems K103466: Arthrex Size 5 Univers II Stems Purpose of Submission This special 510(k) premarket notification… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171841 | Arthrex Shoulder System | 2018 | 1 |
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 35 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 29 ancestors have a recall of any class.
- Of its descendants, K171841 (Arthrex, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K131633.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Arthrex Univers Apex, Size 5 Stem is indicated for:
The Arthrex Univers Apex is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153115: Arthrex Univers Apex, Size 5 Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153115
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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