510(k) · Cleared
ClearedSMR Shoulder System- Revision Stems
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 28, 2011 as substantially equivalent to K100858 (Lima-Lto S.P.A., 2010) and 3 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1991. 33 later devices descend from it.
- Decided
- Jul 28, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K911686 (1991). 29 ancestors in all, the oldest K800494 (1980). 33 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 4 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 3 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 2 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 1 generation backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- This deviceK111212 SMR Shoulder System- Revision StemsLima 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 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · 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 |
|---|---|---|---|---|---|
| −5 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −4 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −3 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −2 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −1 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| 0 (this device) | K111212 | SMR Shoulder System- Revision Stems | 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 |
|---|---|---|
| 1980 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 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? (4)
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…used to help initially seat the body on the stem taper. SMR Revision Stems can be used for anatomical (when coupled with trauma and election humeral bodies, cleared via K100858 and K 0 1263) shoulder replacements. SMR Revision cemented stems are intended to be used with bone cement; SMR Revision uncemente… | 2010 |
| * | K101263 | Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Summary page 2…ropaty; * Revision of a failed primary component. Predicate Devices: * SMR Shoulder System (Lima-Lto, K100858) and SMVR Uncemented Shoulder System (Lima-Lto, K101263); * Global FX humeral stem (DePuy, K98454 1);, * Aequalis Reversed Shoulder Prosthesis (Tornier, K03094 1); Comparable Fea… | 2011 |
| * | K984541 | Global FX Humeral Stem, Global Advantage Humeral HeadSummary page 2…onent. Predicate Devices: * SMR Shoulder System (Lima-Lto, K100858) and SMVR Uncemented Shoulder System (Lima-Lto, K101263); * Global FX humeral stem (DePuy, K98454 1);, * Aequalis Reversed Shoulder Prosthesis (Tornier, K03094 1); Comparable Features to Predicate Device(s): The SMR Revision… | 1999 |
| * | K030941 | Aequalis Reversed Shoulder ProsthesisSummary page 2…00858) and SMVR Uncemented Shoulder System (Lima-Lto, K101263); * Global FX humeral stem (DePuy, K98454 1);, * Aequalis Reversed Shoulder Prosthesis (Tornier, K03094 1); Comparable Features to Predicate Device(s): The SMR Revision stems are similar to the predicate devices in terms of intended u… | 2004 |
What descends from it? (33)
See all 334 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 20 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 7 of the 29 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 SMVR Revision Stems are indicated for the treatment of fractures or revision of a failed primary component in total or hemi-shoulder replacement.
The components are intended for use in cemented and uncemented applications according to their labeled indication.
Total or hemi-shoulder replacement 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;
Revision of a failed primary component.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111212: SMR Shoulder System- Revision Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111212
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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