510(k) · Cleared
ClearedLimacorporate SMR Cta Humeral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jun 7, 2013 as substantially equivalent to K110847 (Lima Corporate S.P.A., 2011) after a 46-day review. Its family tree reaches back 5 generations to 1987.
- Decided
- Jun 7, 2013
- Review
- 46 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K873073 (1987). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK873073 Kirschner Neer-Iii Proximal HumerusKirschner Medical Corp. · 1987
- 4 generations backK961260 Kirschner Sholders with Titanium Plasma SprayBiomet, Inc. · 1997
- 3 generations backK992525 Acumed Modular Shoulder SystemAcu Med, Inc. · 2000 · Recalled
- 2 generations backK100858 Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder…Lima-Lto S.P.A. · 2010 · Recalled
- 1 generation backK110847 SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A. · 2011
- This deviceK131112 Limacorporate SMR Cta Humeral HeadsLima Corporate S.P.A. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K873073 | Kirschner Neer-Iii Proximal Humerus | Kirschner Medical Corp. | 1987 | — |
| −4 | K961260 | Kirschner Sholders with Titanium Plasma Spray | Biomet, Inc. | 1997 | — |
| −3 | K992525 | Acumed Modular Shoulder System | Acu Med, Inc. | 2000 | 1 |
| −2 | K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System -… | Lima-Lto S.P.A. | 2010 | 2 |
| −1 | K110847 | SMR Shoulder System - Cta Humeral Heads | Lima Corporate S.P.A. | 2011 | — |
| 0 (this device) | K131112 | Limacorporate SMR Cta Humeral Heads | Lima Corporate S.P.A. | 2013 | — |
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 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K110847 | SMR Shoulder System - Cta Humeral HeadsSummary page 1…r HSD Shoulder joint humeral (hemi-shoulder) metallic Prosthesis uncemented prosthesis per 21 CFR 888.3690 Description: The SMR CTA Humeral Heads (clcared via 510(k): K110847) are intended for use with a humcral body — humeral stcm assembly in total or hemi-shoulder joint arthroplasty. The CTA heads arc… | 2011 |
| † | K110598 | SMR Reverse Shoulder System | 2011 |
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 26 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 19 ancestors have a recall of any class.
- 3 other devices also cite its predicate K110847.
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. 2013, 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 SMR CTA Humeral Heads are intended for use with cemented and uncemented SMR humeral body — humeral stem assemblies in total or hemi- shoulder joint arthroplasty. The glenoid is intended for cemented use only. Total and hemi-shoulder replacement utilizing the CTA head is indicated for patients suffering from dnsablllty due to:
. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
. Inflammatory.degenerative joint disease such as rheumatoid arthritis;
* Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
* Cuff tear arthropathy.
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/K131112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131112: Limacorporate SMR Cta Humeral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131112
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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