510(k) · Cleared
ClearedSMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral 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 Jan 22, 2026 as substantially equivalent to K243826 (Lima Corporate S.P.A., 2025) after a 177-day review. Its family tree reaches back 20 generations to 1991. 1 of the 205 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 22, 2026
- Review
- 177 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K911686 (1991). 204 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 205 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 16 generations between
- 3 generations backK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
- 2 generations backK223876 SMR Shoulder SystemLima Corporate S.P.A. · 2023
- 1 generation backK243826 SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 2025
- This deviceK252352 SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A. · 2026
Show all 20 generations
- Root · 20 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 19 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 18 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 17 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 16 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 15 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 14 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 13 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 12 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 11 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 10 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 9 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 8 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 7 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 6 generations backK191963 SMR Finned Short StemsLima Corporate S.P.A. · 2019
- 5 generations backK200171 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020
- 4 generations backK210717 Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021
- 3 generations backK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
- 2 generations backK223876 SMR Shoulder SystemLima Corporate S.P.A. · 2023
- 1 generation backK243826 SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 2025
- This deviceK252352 SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A. · 2026
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder7 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −19 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −18 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −17 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −16 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −15 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −14 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −13 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −12 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −11 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −10 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −9 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −8 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −7 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −6 | K191963 | SMR Finned Short Stems | Lima Corporate S.P.A. | 2019 | — |
| −5 | K200171 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2020 | — |
| −4 | K210717 | Bone Screws dia. 5,0 mm | Lima Corporate S.P.A. | 2021 | — |
| −3 | K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022 | — |
| −2 | K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023 | — |
| −1 | K243826 | SMR Reverse HP Shoulder System | Lima Corporate S.P.A. | 2025 | — |
| 0 (this device) | K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | Lima Corporate S.P.A. | 2026 | — |
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 | 14 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 13 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 11 | 0 |
| 2004 | 9 | 0 |
| 2005 | 10 | 0 |
| 2006 | 12 | 0 |
| 2007 | 9 | 0 |
| 2008 | 8 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 7 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K243826 | SMR Reverse HP Shoulder SystemSummary page 16…pany Device name Cleared via 1 LimaCorporate SMR Reverse HP Shoulder System K243826 (Primary S.p.A. Predicate) 2 Exatech, INC. Exactech Equinoxe Reverse Shoulder… | 2025 |
| † | K150458 | Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere | 2015 |
| † | K222427 | PRIMA TT Glenoid | 2022 |
| † | K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | 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 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 68 of the 204 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 (796 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.
The PRIMA Glenoid 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 PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.
The PRIMA Humeral System is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature patients. 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 PRIMA Short Stem and PRIMA Short Stem Plus are intended for use in cementless and cemented applications, at the discretion of the surgeon.
The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to:
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis),
• Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis,
• Avascular necrosis of the humeral head,
• Traumatic/post-traumatic arthritis,
• Fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains,
• Post-fracture deformity with intact rotator cuff, where adequate fixation can be achieved and adequate bone stock remains,
• Cuff tear arthropathy (CTA Heads only).
The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e. in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy).
Revision surgery with retention of the PRIMA Short Stem and PRIMA Short Stem Plus are intended as conversion surgery from anatomic to reverse, where the stem is stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses.
The PRIMA reverse implant is indicated for patients suffering from pain and disability due to:
• Rotator cuff tear arthropathy,
• Osteoarthritis with rotator cuff tear,
• Rheumatoid arthritis with rotator cuff tear,
• Massive irreparable rotator cuff tear,
• Avascular necrosis of the humeral head,
• Correction of functional deformity, where adequate fixation can be achieved and adequate bone stock remains,
• Fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains.
The PRIMA Humeral System consists of the following single use components:
• Anatomic configuration:
- Stem
- adaptor for humeral heads.
• Reverse configuration:
- stem
- reverse tray and polyethylene reverse insert, or
- metallic reverse insert.
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/K252352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252352: SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252352
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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