510(k) · Cleared
ClearedSMR TT Augmented Glenoid System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Nov 22, 2019 as substantially equivalent to K133349 (Lima Corporate S.P.A., 2014) and 2 other predicates after a 144-day review. Its family tree reaches back 14 generations to 1991. 1 of the 129 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Nov 22, 2019
- Review
- 144 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K911686 (1991). 116 ancestors in all, the oldest K790987 (1979). 12 later devices descend from it, 2 citing it directly. 1 of the 129 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations between
- 3 generations backK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
- 2 generations backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- 1 generation backK172502 Comprehensive Augmented Glenoid Components, Comprehensive Standard…Biomet Manufacturing Corp · 2018 · Recalled
- This deviceK191746 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019
- Descendant · cites it directly · 11 of its ownK200171 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020
- Descendant · cites it directly · 8 of its ownK210717 Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021
- Descendant · 2 generations on · 7 of its ownK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
- Descendant · 3 generations on · 3 of its ownK223876 SMR Shoulder SystemLima Corporate S.P.A. · 2023
- Descendant · 3 generations on · 2 of its ownK222427 PRIMA TT GlenoidLima Corporate S.P.A. · 2022 · Recalled
Show all 14 generations
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 7 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 6 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 5 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 4 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 3 generations backK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
- 2 generations backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- 1 generation backK172502 Comprehensive Augmented Glenoid Components, Comprehensive Standard…Biomet Manufacturing Corp · 2018 · Recalled
- This deviceK191746 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019
Showing 5 of 12 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 12 · See all- K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020 · cites it directly11descendants
- K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021 · cites it directly8descendants
- K220792SMR Reverse LinerLima Corporate S.P.A. · 2022 · 2 generations on7descendants
- K223876SMR Shoulder SystemLima Corporate S.P.A. · 2023 · 3 generations on3descendants
- K222427PRIMA TT GlenoidLima Corporate S.P.A. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −13 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −10 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −7 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −6 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −5 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −4 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −3 | K093803 | Bio-Modular Reverse Sholder | Biomet Manufacturing Corp | 2010 | — |
| −2 | K131353 | Comprehensive Reverse Shoulder - Titanium Glenosphere | Biomet Manufacturing Corp | 2013 | — |
| −1 | K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate… | Biomet Manufacturing Corp | 2018 | 1 |
| 0 (this device) | K191746 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2019 | — |
| +1 | K200171 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2020 | — |
| +1 | K210717 | Bone Screws dia. 5,0 mm | Lima Corporate S.P.A. | 2021 | — |
| +2 | K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022 | — |
| +3 | K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023 | — |
| +3 | K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | 2022 | 3 |
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 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 9 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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 PHX device
- #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 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 |
|---|---|---|---|
| * | K133349 | SMR TT Metal Back GlenoidSummary page 8…increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric). Predicate Devices: • SMR TT Metal Back Glenoid (Limacorporate, K133349) • Aequalis PerFORM and PerFORM+ Reversed Glenoids (Tornier Inc., K161742) • Comprehensive Augmented Glenoid (Biomet Manufa… | 2014 |
| * | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidSummary page 8…oncentric and eccentric). Predicate Devices: • SMR TT Metal Back Glenoid (Limacorporate, K133349) • Aequalis PerFORM and PerFORM+ Reversed Glenoids (Tornier Inc., K161742) • Comprehensive Augmented Glenoid (Biomet Manufacturing Corp, K172502) Summary of technology comparison: The intended use, d… | 2016 |
| * | K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Summary page 8…id (Limacorporate, K133349) • Aequalis PerFORM and PerFORM+ Reversed Glenoids (Tornier Inc., K161742) • Comprehensive Augmented Glenoid (Biomet Manufacturing Corp, K172502) Summary of technology comparison: The intended use, design, and materials of the SMR TT Augmented Glenoid System are substantia… | 2018 |
What descends from it? (12)
See all 122 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 28 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 36 of the 116 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K200171 (Lima Corporate S.P.A., 2020) has gone furthest, with 11 descendants of its own.
- 5 other devices also cite its predicate K133349.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PHX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHX
72in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHX
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHX
2,848in 2025
MAUDE reports naming product code PHX, 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 | 5 | 97 | 0 | 0 |
| 2008 | 6 | 79 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 8 | 124 | 0 | 0 |
| 2011 | 12 | 94 | 0 | 0 |
| 2012 | 12 | 114 | 0 | 0 |
| 2013 | 8 | 143 | 0 | 0 |
| 2014 | 12 | 110 | 0 | 0 |
| 2015 | 4 | 206 | 2 | 14 |
| 2016 | 4 | 132 | 0 | 5 |
| 2017 | 11 | 141 | 0 | 25 |
| 2018 | 14 | 127 | 1 | 323 |
| 2019 | 9 | 144 | 3 | 504 |
| 2020 | 13 | 143 | 3 | 986 |
| 2021 | 21 | 143 | 8 | 1,404 |
| 2022 | 9 | 198 | 0 | 1,342 |
| 2023 | 9 | 154 | 7 | 1,401 |
| 2024 | 9 | 139 | 1 | 2,142 |
| 2025 | 9 | 72 | 3 | 2,848 |
| 2026 | 18 | 130 | 7 | — |
What is it indicated for?
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in 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…
Read the full statement (613 words)
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in 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);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).
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 (disabled 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.
The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.
On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
The constructs and use specifications are listed in the Indications for Use form, including cemented and uncemented use as applicable.
*NOTE:
• In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.
• The SMR Metal Backed Glenoid/Connector/Glenosphere construct, used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
• SMR Lateralized Connectors are not indicated for use with glenoid bone grafting techniques.
• In the US the SMR TT Metal Back Baseplate used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws; while when used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
• If a SMR TT Hybrid Glenoid is in place and revision to a reverse prosthesis is required, the patient can be revised by removing the polyethylene baseplate, leaving the metal peg in place and by connecting it to the SMR TT Hybrid Glenoid Reverse Baseplate. The SMR TT Hybrid Glenoid Reverse Baseplate is intended for uncemented use with the addition of screws for fixation.
• The Dia. 50, 52 and 54mm Humeral Heads with + 3mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric). The Dia. 52 and 54mm Humeral Heads with + 2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191746 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191746: SMR TT Augmented Glenoid System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191746
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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