510(k) · Cleared
ClearedSMR 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 Dec 21, 2023 as substantially equivalent to K223876 (Lima Corporate S.P.A., 2023) and 1 other predicate after a 247-day review. Its family tree reaches back 19 generations to 1991. 1 of the 219 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 21, 2023
- Review
- 247 days
- Class
- Class II
- Product code
- MBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K911686 (1991). 218 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 219 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 15 generations between
- 3 generations backK210717 Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021
- 2 generations backK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
- 1 generation backK223876 SMR Shoulder SystemLima Corporate S.P.A. · 2023
- This deviceK231099 SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2023
Show all 19 generations
- Root · 19 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 18 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 17 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 16 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 15 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 14 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 13 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 12 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 11 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 10 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 9 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 8 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 7 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 6 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 5 generations backK191963 SMR Finned Short StemsLima Corporate S.P.A. · 2019
- 4 generations backK200171 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020
- 3 generations backK210717 Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021
- 2 generations backK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
- 1 generation backK223876 SMR Shoulder SystemLima Corporate S.P.A. · 2023
- This deviceK231099 SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2023
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder6 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −18 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −17 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −16 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −15 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −14 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −13 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −12 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −11 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −10 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −9 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −8 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −7 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −6 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −5 | K191963 | SMR Finned Short Stems | Lima Corporate S.P.A. | 2019 | — |
| −4 | K200171 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2020 | — |
| −3 | K210717 | Bone Screws dia. 5,0 mm | Lima Corporate S.P.A. | 2021 | — |
| −2 | K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022 | — |
| −1 | K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023 | — |
| 0 (this device) | K231099 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2023 | — |
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 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 15 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 15 | 0 |
| 2001 | 11 | 0 |
| 2002 | 7 | 0 |
| 2003 | 11 | 0 |
| 2004 | 10 | 0 |
| 2005 | 10 | 0 |
| 2006 | 13 | 0 |
| 2007 | 10 | 0 |
| 2008 | 9 | 0 |
| 2009 | 2 | 0 |
| 2010 | 8 | 0 |
| 2011 | 9 | 0 |
| 2012 | 8 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K223876 | SMR Shoulder SystemSummary page 7…PHX cemented prosthesis per 21 CFR 888.3660 Description: The SMR Hybrid Glenoid System (K223876) is a modular shoulder system intended to be used in combination with previously cleared devices of the SMR Shoulder System. The… | 2023 |
| * | K212356 | Exactech® Equinoxe® Laser Cage GlenoidSummary page 9…redicate) LimaCorporate S.p.A SMR Hybrid Glenoid System K223876 2 Exactech, Inc. Exactech® Equinoxe® Laser Cage Glenoid K212356 Traditional 510(k) – SMR Hybrid Glenoid System Page 3 of 4 (K231099) 19-December-2023… | 2022 |
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 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 75 of the 218 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K223876.
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. 2023, 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 (357 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; in case of SMR Short Stems only if sufficient bone stock remains;
• 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 all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
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/K231099 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231099: SMR Hybrid Glenoid System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231099
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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