510(k) · Cleared
ClearedSMR TT Metal Back 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 Jun 3, 2014 as substantially equivalent to K113254 (Lima Corporate S.P.A., 2012) and 3 other predicates after a 216-day review. Its family tree reaches back 12 generations to 1991. 1 of the 110 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it.
- Decided
- Jun 3, 2014
- Review
- 216 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K911686 (1991). 89 ancestors in all, the oldest K790987 (1979). 20 later devices descend from it, 6 citing it directly. 1 of the 110 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations between
- 3 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 2 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 1 generation backK120174 Deput Delta Xtend Reverse ShoulderDepuy France · 2012 · Recalled
- This deviceK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
- Descendant · cites it directly · 12 of its ownK191746 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019
- Descendant · cites it directly · 12 of its ownK163397 SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2017 · Recalled
- Descendant · 2 generations on · 11 of its ownK200171 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020
- Descendant · 2 generations on · 8 of its ownK210717 Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021
- Descendant · 2 generations on · 8 of its ownK190911 Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
Show all 12 generations
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 11 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 10 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 9 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 8 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 5 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 4 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 3 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 2 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 1 generation backK120174 Deput Delta Xtend Reverse ShoulderDepuy France · 2012 · Recalled
- This deviceK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations back · 2008
Most influential descendants
Showing 5 of 20 · See all- K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019 · cites it directly12descendants
- K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2017 · cites it directly12descendants
- K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020 · 2 generations on11descendants
- K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021 · 2 generations on8descendants
- K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −11 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −8 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −5 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −4 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −3 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −2 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −1 | K120174 | Deput Delta Xtend Reverse Shoulder | Depuy France | 2012 | 2 |
| 0 (this device) | K133349 | SMR TT Metal Back Glenoid | Lima Corporate S.P.A. | 2014 | — |
| +1 | K191746 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2019 | — |
| +1 | K163397 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2017 | 1 |
| +2 | K200171 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2020 | — |
| +2 | K210717 | Bone Screws dia. 5,0 mm | Lima Corporate S.P.A. | 2021 | — |
| +2 | K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K113254 | SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsSummary page 4…noid is nearly identical to the design of the SMR Modular Glenoid component cleared for use in anatomic shoulder replacement as part of the SMR Anatomic Shoulder System (K113254) and for use in reverse shoulder replacement as part of the SMR Reverse Shoulder System (K110598) except that the subject device… | 2012 |
| * | K120174 | Deput Delta Xtend Reverse ShoulderSummary page 5…oid is intended for uncemented use with the addition of screws for fixation. SMR Modutar Glenoids (Limacorporate, K113254): Delta Xtend Reverse Shoulder System (DePuy, K120174); Aequalis Reversed Shoulder Prosthesis (Tomier, K100142-K081059). C ble Feat Predicate Device(s): The SMR TT Metal Back Glenoi… | 2012 |
| * | K100142 | Aequalis Reversed Shoulder ProsthesisSummary page 5…crews for fixation. SMR Modutar Glenoids (Limacorporate, K113254): Delta Xtend Reverse Shoulder System (DePuy, K120174); Aequalis Reversed Shoulder Prosthesis (Tomier, K100142-K081059). C ble Feat Predicate Device(s): The SMR TT Metal Back Glenoid is similar to the predicate devices in terms of intende… | 2010 |
| * | K081059 | Aequalis Reversed Shoulder ProsthesisSummary page 5…r fixation. SMR Modutar Glenoids (Limacorporate, K113254): Delta Xtend Reverse Shoulder System (DePuy, K120174); Aequalis Reversed Shoulder Prosthesis (Tomier, K100142-K081059). C ble Feat Predicate Device(s): The SMR TT Metal Back Glenoid is similar to the predicate devices in terms of intended use, i… | 2008 |
What descends from it? (20)
See all 206 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 27 of the 89 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K191746 (Lima Corporate S.P.A., 2019) has gone furthest, with 12 descendants of its own.
- 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. 2014, 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 TT Metal Back Glenoid is intended for use in total primary or revision shoulder joint replacement with either the SMR Anatomic Shoulder System or the SMR Reverse 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…
Read the full statement (200 words)
The SMR TT Metal Back Glenoid is intended for use in total primary or revision shoulder joint replacement with either the SMR Anatomic Shoulder System or the SMR Reverse 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);
When used as part of the SMR Anatomic Shoulder System, the SMR TT Metal Back Glenoid is intended for use with bone cement and should be used without bone screws.
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabling shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
When used as part of the SMR Reverse Shoulder System, the SMR TT Metal Back Glenoid is intended for uncemented use with the addition of screws for fixation.
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/K133349 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133349: SMR TT Metal Back Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133349
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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