510(k) · Cleared
ClearedSMR Modular Glenoid
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 May 28, 2015 as substantially equivalent to K113254 (Lima Corporate S.P.A., 2012) and 2 other predicates after a 196-day review. Its family tree reaches back 13 generations to 1991. 1 of the 91 devices in its family, counting itself, has a Class I recall.
- Decided
- May 28, 2015
- Review
- 196 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K911686 (1991). 90 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 91 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations between
- 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 2 generations backK120174 Deput Delta Xtend Reverse ShoulderDepuy France · 2012 · Recalled
- 1 generation backK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
- This deviceK143256 SMR Modular GlenoidLima Corporate S.P.A. · 2015
Show all 13 generations
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 11 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 10 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 9 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 6 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 5 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 4 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 2 generations backK120174 Deput Delta Xtend Reverse ShoulderDepuy France · 2012 · Recalled
- 1 generation backK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
- This deviceK143256 SMR Modular GlenoidLima Corporate S.P.A. · 2015
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −12 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −9 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −6 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −5 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −4 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −3 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −2 | K120174 | Deput Delta Xtend Reverse Shoulder | Depuy France | 2012 | 2 |
| −1 | K133349 | SMR TT Metal Back Glenoid | Lima Corporate S.P.A. | 2014 | — |
| 0 (this device) | K143256 | SMR Modular Glenoid | Lima Corporate S.P.A. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K113254 | SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsSummary page 5…eplacement, is intended for use with bone cement and should be used without bone screws. Predicate Devices: SMR Metal Back Glenoid and liners (Limacorporate, K113254); SMR TT Metal Back Glenoid and liners (Limacorporate, K133349); Bio-modular Shoulder System (Biomet, K030710… | 2012 |
| * | K133349 | SMR TT Metal Back GlenoidSummary page 5…ut bone screws. Predicate Devices: SMR Metal Back Glenoid and liners (Limacorporate, K113254); SMR TT Metal Back Glenoid and liners (Limacorporate, K133349); Bio-modular Shoulder System (Biomet, K030710). Comparable Features to Predicate Device(s): The new sizes of the li… | 2014 |
| * | K030710 | Bio-Modular Shoulder SystemSummary page 5…Back Glenoid and liners (Limacorporate, K113254); SMR TT Metal Back Glenoid and liners (Limacorporate, K133349); Bio-modular Shoulder System (Biomet, K030710). Comparable Features to Predicate Device(s): The new sizes of the liners are identical in design, materials, function, and in… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 12 months on median.
- 27 of the 90 ancestors have a recall of any class; 1 has a Class I recall.
- 5 other devices also cite its predicate K113254.
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 SMR Modular Glenoid and liner is intended for use in total primary or revision shoulder joint replacement with the SMR Anatomic Shoulder System. The SMR Anatomic Shoulder System 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…
Read the full statement (119 words)
The SMR Modular Glenoid and liner is intended for use in total primary or revision shoulder joint replacement with the SMR Anatomic Shoulder System.
The SMR Anatomic Shoulder System 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;
• Revision of a failed primary implant;
• Cuff tear arthropathy (CTA Heads only).
The SMR Metal Backed Glenoid/Liner construct when used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143256: SMR Modular Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143256
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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