510(k) · Cleared
Recalled · Class II · 2023SMR Hybrid Glenoid System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Jun 29, 2017 as substantially equivalent to K130642 (Lima Corporate S.P.A., 2013) and 7 other predicates after a 206-day review. Its family tree reaches back 13 generations to 1991. 1 of the 120 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it. It has been recalled once.
- Decided
- Jun 29, 2017
- Review
- 206 days
- Class
- Class II
- Product code
- MBF
- Recalls
- 1
- Predicates
- 8
Its longest line of descent runs back 13 generations to K911686 (1991). 107 ancestors in all, the oldest K790987 (1979). 12 later devices descend from it, 4 citing it directly. 1 of the 120 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 deviceK163397 SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2017
- Descendant · cites it directly · 8 of its ownK190911 Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
- 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
- Descendant · 4 generations on · 1 of its ownK243826 SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 2025
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 deviceK163397 SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations back · 2008
Most influential descendants
Showing 5 of 12 · See all- K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019 · 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
- K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 2025 · 4 generations on1descendant
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) | K163397 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2017 | — |
| +1 | K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate | 2019 | — |
| +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 |
| +4 | K243826 | SMR Reverse HP Shoulder System | Lima Corporate S.P.A. | 2025 | — |
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 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 MBF device
- #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K130642 | SMR 3-Pegs GlenoidsSummary page 8…K163397 page 4 of 4 Predicate Devices: SMR 3-Pegs Glenoid, Limacorporate (K130642, K153722) Comprehensive Modular Hybrid Glenoid, Biomet Orthopedics, Inc. (K060694) Trabecular Metal Glenoid, Zimmer (K0… | 2013 |
| * | K153722 | SMR 3-Pegs GlenoidsSummary page 8…e 8 === K163397 page 4 of 4 Predicate Devices: SMR 3-Pegs Glenoid, Limacorporate (K130642, K153722) Comprehensive Modular Hybrid Glenoid, Biomet Orthopedics, Inc. (K060694) Trabecular Metal Glenoid, Zimmer (K071090)… | 2016 |
| * | K060694 | Modular Hybrid GlenoidSummary page 8…K163397 page 4 of 4 Predicate Devices: SMR 3-Pegs Glenoid, Limacorporate (K130642, K153722) Comprehensive Modular Hybrid Glenoid, Biomet Orthopedics, Inc. (K060694) Trabecular Metal Glenoid, Zimmer (K071090) SMR TT Metal Back, Limacorporate (K133349) SMR Glenospheres with conne… | 2006 |
| * | K071090 | Trabecular Metal Glenoid- B/F Complete Shoulder SolutionSummary page 8…SMR 3-Pegs Glenoid, Limacorporate (K130642, K153722) Comprehensive Modular Hybrid Glenoid, Biomet Orthopedics, Inc. (K060694) Trabecular Metal Glenoid, Zimmer (K071090) SMR TT Metal Back, Limacorporate (K133349) SMR Glenospheres with connector and Screw, Limacorporate (K110598, K1… | 2007 |
| * | K133349 | SMR TT Metal Back GlenoidSummary page 8…722) Comprehensive Modular Hybrid Glenoid, Biomet Orthopedics, Inc. (K060694) Trabecular Metal Glenoid, Zimmer (K071090) SMR TT Metal Back, Limacorporate (K133349) SMR Glenospheres with connector and Screw, Limacorporate (K110598, K142139) Bio-Modular Shoulder System, Biomet… | 2014 |
| * | K110598 | SMR Reverse Shoulder SystemSummary page 8…(K060694) Trabecular Metal Glenoid, Zimmer (K071090) SMR TT Metal Back, Limacorporate (K133349) SMR Glenospheres with connector and Screw, Limacorporate (K110598, K142139) Bio-Modular Shoulder System, Biomet Orthopedics, Inc. (K030710) Summary of technology comparison: The inten… | 2011 |
| * | K142139 | SMR 40MM GlenosphereSummary page 8…Trabecular Metal Glenoid, Zimmer (K071090) SMR TT Metal Back, Limacorporate (K133349) SMR Glenospheres with connector and Screw, Limacorporate (K110598, K142139) Bio-Modular Shoulder System, Biomet Orthopedics, Inc. (K030710) Summary of technology comparison: The intended use, design… | 2014 |
| * | K030710 | Bio-Modular Shoulder SystemSummary page 8…imacorporate (K133349) SMR Glenospheres with connector and Screw, Limacorporate (K110598, K142139) Bio-Modular Shoulder System, Biomet Orthopedics, Inc. (K030710) Summary of technology comparison: The intended use, design, and materials of the SMR Hybrid Glenoid System are substantially eq… | 2003 |
What descends from it? (12)
See all 124 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 21, 2023 | Class II | Z-1317-2023 | Process control | Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the… |
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 26 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 34 of the 107 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K190911 (Limacorporate, 2019) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K130642.
How does its category compare?
All MBF devicesMBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MBF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBF
144in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBF
255in 2025
MAUDE reports naming product code MBF, 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 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 1 | — | 1 | 16 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 1 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 49 |
| 2016 | 0 | — | 0 | 85 |
| 2017 | 2 | — | 1 | 193 |
| 2018 | 1 | — | 1 | 99 |
| 2019 | 2 | — | 2 | 47 |
| 2020 | 2 | — | 0 | 24 |
| 2021 | 1 | — | 0 | 36 |
| 2022 | 4 | 164 | 8 | 114 |
| 2023 | 4 | 144 | 1 | 143 |
| 2024 | 2 | — | 0 | 164 |
| 2025 | 2 | — | 0 | 255 |
| 2026 | 1 | — | 0 | — |
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 (576 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 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 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.
*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.
« 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 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 Hybrid Glenoid Reverse Baseplate. The SMR Hybrid Glenoid Reverse Baseplate is intended for uncemented use with the addition of screws for fixation.
« The Dia. 50, 52 and 54 mm Humeral Heads with + 3mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).
The Dia. 52 and 54 mm Humeral Heads with + 2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).
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/K163397 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163397: SMR Hybrid Glenoid System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163397
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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