510(k) · Cleared
Recalled · Class II · 2025PRIMA Humeral System and SMR Glenosphere Ø42
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 Feb 25, 2022 as substantially equivalent to K190290 (Encore Medical L.P., 2019) and 6 other predicates after a 176-day review. Its family tree reaches back 18 generations to 1991. 1 of the 188 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 25, 2022
- Review
- 176 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 2
- Predicates
- 7
Its longest line of descent runs back 18 generations to K911686 (1991). 185 ancestors in all, the oldest K790987 (1979). 2 later devices descend from it, 2 citing it directly. 1 of the 188 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 14 generations between
- 3 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- 2 generations backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- 1 generation backK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
- This deviceK212800 PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 2022
- Descendant · cites it directly · 1 of its ownK233712 PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. · 2024
- Descendant · cites it directly · 0 of its ownK251184 AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder…Encore Medical L.P. · 2025
Show all 18 generations
- Root · 18 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 17 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 16 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 15 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 14 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 13 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 12 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 11 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 10 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 9 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 8 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 7 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 6 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 5 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 4 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- 3 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- 2 generations backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- 1 generation backK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
- This deviceK212800 PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 2022
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder4 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −17 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −16 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −15 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −14 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −13 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −12 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −11 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −10 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −9 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −8 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −7 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −6 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −5 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −4 | K132285 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2013 | — |
| −3 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015 | — |
| −2 | K190521 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2019 | — |
| −1 | K201315 | PERFORM Humeral System – Stem | Tornier, Inc. | 2020 | 1 |
| 0 (this device) | K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | Lima Corporate S.P.A. | 2022 | — |
| +1 | K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | 2024 | — |
| +1 | K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System… | Encore Medical L.P. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 8 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 10 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 5 | 0 |
| 2005 | 9 | 0 |
| 2006 | 11 | 0 |
| 2007 | 8 | 0 |
| 2008 | 10 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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? (7)
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 |
|---|---|---|---|
| * | K190290 | AltiVate Reverse Humeral Stem, 48mmSummary page 12…DJO: • DJO, AltiVate Anatomic™ AltiVate Reverse Humeral Shoulder System (K162024) Stem (K190290) • DJO, AltiVate Reverse Humeral Stem, AltiVate Reverse Small… | 2019 |
| * | K162024 | AltiVate Anatomic Shoulder SystemSummary page 12…tional predicate devices DJO: • DJO, AltiVate Anatomic™ AltiVate Reverse Humeral Shoulder System (K162024) Stem (K190290) • DJO, AltiVate Reverse Humeral Stem… | 2016 |
| * | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Summary page 12…ivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert (K172351), PRIMA • DJO, AltiVate Anatomic to Humeral System… | 2017 |
| * | K173073 | AltiVate Anatomic to Reverse Conversion ModuleSummary page 12…• DJO, AltiVate Anatomic to Humeral System Reverse Conversion Module (K173073) • TORNIER, Aequalis Ascend Flex… | 2017 |
| * | K122698 | Aequalis Ascend Flex Shoulder SystemSummary page 12…(K173073) • TORNIER, Aequalis Ascend Flex (K122698) • TORNIER, PERFORM Humeral… | 2013 |
| * | K201315 | PERFORM Humeral System – StemSummary page 12…(K122698) • TORNIER, PERFORM Humeral System – Stem (K201315) The following predicate devices were chosen for the subject SMR Glenosphere Ø42: Product Primary predicate d… | 2020 |
| * | K110598 | SMR Reverse Shoulder SystemSummary page 8…on, the PRIMA Stem is coupled with a Glenosphere through a Reverse Tray and a Reverse Insert. PRIMA Stem is compatible with already cleared SMR Glenospheres Ø36 and Ø40 (K110598, K142139, K163397). In addition, PRIMA Stem is compatible with the new SMR Glenosphere Ø42 (CoCrMo), subject of the present 510(k… | 2011 |
| † | K133349 | SMR TT Metal Back Glenoid | 2014 |
| † | K081016 | Smith & Nephew, Inc., Promos Reverse Shoulder System | 2008 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| May 19, 2025 | Class II | Z-2025-2025 | Process design | There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing. |
| May 19, 2025 | Class II | Z-2024-2025 | Process design | There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing. |
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 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 54 of the 185 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K233712 (Lima Corporate S.P.A., 2024) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K190290.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
PRIMA Humeral System 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 Stem is intended for use in cementless and cemented applications, at the discretion of the surgeon. The PRIMA Anatomic implant…
Read the full statement (576 words)
PRIMA Humeral System
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 Stem is 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 Stem is intended as conversion surgery from anatomic to reverse, where the PRIMA 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
- reverse insert.
The PRIMA Humeral System is intended to be used with all SMR glenoid implants.
SMR Glenosphere Ø42
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.
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/K212800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212800: PRIMA Humeral System and SMR Glenosphere Ø42.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212800
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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