510(k) · Cleared
Recalled · 2008Acumed Modular Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acu Med, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Feb 4, 2000 as substantially equivalent to K961260 (Biomet, Inc., 1997) and 1 other predicate after a 191-day review. Its family tree reaches back 2 generations to 1987. 76 later devices descend from it. It has been recalled once.
- Decided
- Feb 4, 2000
- Review
- 191 days
- Class
- Class II
- Product code
- HSD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K873073 (1987). 6 ancestors in all. 76 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK873073 Kirschner Neer-Iii Proximal HumerusKirschner Medical Corp. · 1987
- 1 generation backK961260 Kirschner Sholders with Titanium Plasma SprayBiomet, Inc. · 1997
- This deviceK992525 Acumed Modular Shoulder SystemAcu Med, Inc. · 2000
- Descendant · cites it directly · 38 of its ownK101263 Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR…Lima-Lto S.P.A. · 2011
- Descendant · cites it directly · 37 of its ownK100858 Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder…Lima-Lto S.P.A. · 2010 · Recalled
- Descendant · cites it directly · 34 of its ownK111097 Humelock Cemented Shoulder ProsthesisFx Solutions · 2011 · Recalled
- Descendant · 2 generations on · 34 of its ownK110847 SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A. · 2011
- Descendant · 2 generations on · 33 of its ownK111212 SMR Shoulder System- Revision StemsLima Corporate S.P.A. · 2011
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Lima-Lto S.P.A. · 2011 · cites it directly38descendants
- K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Lima-Lto S.P.A. · 2010 · cites it directly37descendants
- K111097Humelock Cemented Shoulder ProsthesisFx Solutions · 2011 · cites it directly34descendants
- K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A. · 2011 · 2 generations on34descendants
- K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A. · 2011 · 2 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873073 | Kirschner Neer-Iii Proximal Humerus | Kirschner Medical Corp. | 1987 | — |
| −1 | K961260 | Kirschner Sholders with Titanium Plasma Spray | Biomet, Inc. | 1997 | — |
| 0 (this device) | K992525 | Acumed Modular Shoulder System | Acu Med, Inc. | 2000 | — |
| +1 | K101263 | Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder… | Lima-Lto S.P.A. | 2011 | — |
| +1 | K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System -… | Lima-Lto S.P.A. | 2010 | 2 |
| +1 | K111097 | Humelock Cemented Shoulder Prosthesis | Fx Solutions | 2011 | 2 |
| +2 | K110847 | SMR Shoulder System - Cta Humeral Heads | Lima Corporate S.P.A. | 2011 | — |
| +2 | K111212 | SMR Shoulder System- Revision Stems | Lima Corporate S.P.A. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 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 HSD? 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 HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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 |
|---|---|---|---|
| * | K961260 | Kirschner Sholders with Titanium Plasma SpraySummary page 1…Jeffers Labeling/Promotional Materials: See Appendix D Substantial Equivalence: This device is similar in size, materid), and intended use to the Atlas Modular Shoulder (K961260) and the Select Shoulder System (K962224). This device is most simildr in design to the Atlas Modular shoulder in that both devic… | 1997 |
| * | K962224 | Select Shoulder Concentric Humeral Head ComponentsSummary page 1…ee Appendix D Substantial Equivalence: This device is similar in size, materid), and intended use to the Atlas Modular Shoulder (K961260) and the Select Shoulder System (K962224). This device is most simildr in design to the Atlas Modular shoulder in that both devices consist of a bead, body, and stem comp… | 1996 |
What descends from it? (76)
See all 764 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101263 | Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -… | 2011 | 38 |
| K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral… | 2010 | 37 |
| K111097 | Humelock Cemented Shoulder Prosthesis | 2011 | 34 |
| K130759 | Humelock II Cementless Shoulder System | 2013 | 31 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2008 | Not classified | Z-0447-2009 | Labeling mix-ups | The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K101263 (Lima-Lto S.P.A., 2011) has gone furthest, with 38 descendants of its own.
- 2 other devices also cite its predicate K961260.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, 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 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Addresses proximal fractures when used with interlocking screws and arthritis of the shoulder joint.
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/K992525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992525: Acumed Modular 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/K992525
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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