510(k) · Cleared
ClearedSMR Reverse HP Shoulder 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 Jul 3, 2025 as substantially equivalent to K223876 (Lima Corporate S.P.A., 2023) after a 203-day review. Its family tree reaches back 19 generations to 1991. 1 of the 205 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jul 3, 2025
- Review
- 203 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K911686 (1991). 203 ancestors in all, the oldest K790987 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 205 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 deviceK243826 SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 2025
- Descendant · cites it directly · 0 of its ownK252352 SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A. · 2026
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 deviceK243826 SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 2025
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder6 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A. · 2026 · cites it directly0descendants
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) | K243826 | SMR Reverse HP Shoulder System | Lima Corporate S.P.A. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K223876 | SMR Shoulder SystemSummary page 6…cemented prosthesis Class: II Product Codes: PHX Primary Predicate: LimaCorporate SMR Shoulder System (K223876) Reference Devices: LimaCorporate SMR Reverse System (K100858/K110598/K142139) LimaCorpor… | 2023 |
| † | K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral… | 2010 |
| † | K110598 | SMR Reverse Shoulder System | 2011 |
| † | K142139 | SMR 40MM Glenosphere | 2014 |
| † | K112898 | Delta TT Cups, Delta TT Liners, Bone Screws | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | 2026 | 0 |
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 34 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 68 of the 203 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K252352 (Lima Corporate S.P.A., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K223876.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 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…
Read the full statement (359 words)
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 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 Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.
R=Reverse
*NOTE:
» When considering the humeral side, SMR Glenosphere @42 can be coupled only with PRIMA Humeral System.
» 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 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.
* Glenosphere size must be chose according to clinical case, considering both joint dimension and soft tissues quality. In case of small shoulder join and/or stiff joint a smaller, surgeon should be prepared to use smaller glenosphere, such as 36 mm CoCrMo one.
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/K243826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243826: SMR Reverse HP Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243826
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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