510(k) · Cleared
ClearedSMR Shoulder System - 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 Jul 15, 2011 as substantially equivalent to K100858 (Lima-Lto S.P.A., 2010) and 2 other predicates after a 109-day review. Its family tree reaches back 4 generations to 1987. 34 later devices descend from it.
- Decided
- Jul 15, 2011
- Review
- 109 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K873073 (1987). 18 ancestors in all. 34 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK873073 Kirschner Neer-Iii Proximal HumerusKirschner Medical Corp. · 1987
- 3 generations backK961260 Kirschner Sholders with Titanium Plasma SprayBiomet, Inc. · 1997
- 2 generations backK992525 Acumed Modular Shoulder SystemAcu Med, Inc. · 2000 · Recalled
- 1 generation backK100858 Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder…Lima-Lto S.P.A. · 2010 · Recalled
- This deviceK110847 SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A. · 2011
- Descendant · cites it directly · 31 of its ownK113254 SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular…Lima Corporate S.P.A. · 2012
- Descendant · 2 generations on · 20 of its ownK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
- Descendant · cites it directly · 14 of its ownK130642 SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2013
- Descendant · cites it directly · 13 of its ownK153722 SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2016
- Descendant · 3 generations on · 12 of its ownK191746 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A. · 2012 · cites it directly31descendants
- K133349SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014 · 2 generations on20descendants
- K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2013 · cites it directly14descendants
- K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2016 · cites it directly13descendants
- K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K873073 | Kirschner Neer-Iii Proximal Humerus | Kirschner Medical Corp. | 1987 | — |
| −3 | K961260 | Kirschner Sholders with Titanium Plasma Spray | Biomet, Inc. | 1997 | — |
| −2 | K992525 | Acumed Modular Shoulder System | Acu Med, Inc. | 2000 | 1 |
| −1 | K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System -… | Lima-Lto S.P.A. | 2010 | 2 |
| 0 (this device) | K110847 | SMR Shoulder System - Cta Humeral Heads | Lima Corporate S.P.A. | 2011 | — |
| +1 | K113254 | SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular… | Lima Corporate S.P.A. | 2012 | — |
| +2 | K133349 | SMR TT Metal Back Glenoid | Lima Corporate S.P.A. | 2014 | — |
| +1 | K130642 | SMR 3-Pegs Glenoids | Lima Corporate S.P.A. | 2013 | — |
| +1 | K153722 | SMR 3-Pegs Glenoids | Lima Corporate S.P.A. | 2016 | — |
| +3 | K191746 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Summary page 1…the glenoid component (total arthroplasty). The articulating surface is polished. The only difference between the SMR CTA Humeral Heads and the humeral heads cleared in K100858 is the addition of a lateral flange to better accommodate the rotator cuff tear arthropaty patient. The SMR CIA Humeral Heads are… | 2010 |
| * | K101263 | Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Summary page 1…, the SMR CTA Humeral Heads are coupled with glenoid components. Humeral stems, humeral bodies, adaptor tapers and glenoid components are the same cleared in K100858 and K101263. SMR CTA Humeral Reads can be used with both cemented and uncemented stems. Glenoid components are intended for cemented use only… | 2011 |
| * | K000575 | Global Advantage Extended Humeral HeadSummary page 3…icate Devices: SMR Shoulder System (Limacorporate, K100858) and SMR Uncemented Shoulder System (Limacorporate, K1O01263); Global Advantage Extended Humeral Heads (DePuy, K000575). Comparable Features to Predicate Device(s): The SMR CTA humeral heads are similar to the predicate devices in terms of intende… | 2000 |
What descends from it? (34)
See all 344 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 5 companies; a new generation was cleared every 9.5 years on median.
- 6 of the 18 ancestors have a recall of any class.
- Of its descendants, K113254 (Lima Corporate S.P.A., 2012) has gone furthest, with 31 descendants of its own.
- 8 other devices also cite its predicate K100858.
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. 2011, 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 disability 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 as stated in the FDA summary.
https://510kreport.com/device/K110847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110847: SMR Shoulder System - Cta Humeral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110847
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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