510(k) · Cleared
Recalled · Class II · 2016SMR Reverse 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 Aug 18, 2011 as substantially equivalent to K081016 (Smith & Nephew, Inc., 2008) and 2 other predicates after a 169-day review. Its family tree reaches back 9 generations to 1991. 44 later devices descend from it. It has been recalled once.
- Decided
- Aug 18, 2011
- Review
- 169 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 9 generations to K911686 (1991). 30 ancestors in all, the oldest K800494 (1980). 44 later devices descend from it, 12 citing it directly.
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations between
- 3 generations backK071379 Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc. · 2007
- 2 generations backK073676 Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc. · 2008
- 1 generation backK091751 Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc. · 2009
- This deviceK110598 SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011
- Descendant · cites it directly · 31 of its ownK113254 SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular…Lima Corporate S.P.A. · 2012
- Descendant · 2 generations on · 20 of its ownK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
- Descendant · 2 generations on · 13 of its ownK153722 SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2016
- Descendant · cites it directly · 13 of its ownK142139 SMR 40MM GlenosphereLima Corporate S.P.A. · 2014
- Descendant · 3 generations on · 12 of its ownK191746 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019
Show all 9 generations
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 7 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 6 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 5 generations backK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- 4 generations backK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- 3 generations backK071379 Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc. · 2007
- 2 generations backK073676 Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc. · 2008
- 1 generation backK091751 Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc. · 2009
- This deviceK110598 SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A. · 2012 · cites it directly31descendants
- K133349SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014 · 2 generations on20descendants
- K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2016 · 2 generations on13descendants
- K142139SMR 40MM GlenosphereLima Corporate S.P.A. · 2014 · cites it directly13descendants
- K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −8 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −5 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| −4 | K062250 | Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2007 | 8 |
| −3 | K071379 | Delta Xtend Reverse Shoulder Modular Stem | DePuy Orthopaedics, Inc. | 2007 | — |
| −2 | K073676 | Depuy Delta Xtend Reverse Shoulder High Mobility Cup | DePuy Orthopaedics, Inc. | 2008 | — |
| −1 | K091751 | Depuy Delta Xtend Reverse Shoulder XLK Cup | DePuy Orthopaedics, Inc. | 2009 | — |
| 0 (this device) | K110598 | SMR Reverse Shoulder System | Lima Corporate S.P.A. | 2011 | — |
| +1 | K113254 | SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular… | Lima Corporate S.P.A. | 2012 | — |
| +2 | K133349 | SMR TT Metal Back Glenoid | Lima Corporate S.P.A. | 2014 | — |
| +2 | K153722 | SMR 3-Pegs Glenoids | Lima Corporate S.P.A. | 2016 | — |
| +1 | K142139 | SMR 40MM Glenosphere | Lima Corporate S.P.A. | 2014 | — |
| +3 | K191746 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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.
Planning a device in PHX? 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? (3)
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 |
|---|---|---|---|
| * | K081016 | Smith & Nephew, Inc., Promos Reverse Shoulder SystemSummary page 6…X Reverse Liners X Glenospheres Connectors Metal Back Glenoid Bone screws B Bad Bad Ead KT T S Predicate Devices: : Promos Reverse Shoulder System (Plus Orthopedics, K081016); Inverse/reverse Shoulder System (Zimmer, K053274); Delta Xtend Reverse Shoulder (DePuy, K091751). Comparable Features to Pred… | 2008 |
| * | K053274 | Anatomical Shoulder Inverse/ReverseSummary page 6…ack Glenoid Bone screws B Bad Bad Ead KT T S Predicate Devices: : Promos Reverse Shoulder System (Plus Orthopedics, K081016); Inverse/reverse Shoulder System (Zimmer, K053274); Delta Xtend Reverse Shoulder (DePuy, K091751). Comparable Features to Predicate Device(s): The SMR Reverse Shoulder System i… | 2006 |
| * | K091751 | Depuy Delta Xtend Reverse Shoulder XLK CupSummary page 6…redicate Devices: : Promos Reverse Shoulder System (Plus Orthopedics, K081016); Inverse/reverse Shoulder System (Zimmer, K053274); Delta Xtend Reverse Shoulder (DePuy, K091751). Comparable Features to Predicate Device(s): The SMR Reverse Shoulder System is similar to the predicate devices in terms of i… | 2009 |
What descends from it? (44)
See all 4412 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113254 | SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws | 2012 | 31 |
| K142139 | SMR 40MM Glenosphere | 2014 | 13 |
| K163397 | SMR Hybrid Glenoid System | 2017 | 12 |
| K113523 | Limacorporate SMR Reverse Shoulder System | 2011 | 10 |
| K130050 | Titan Reverse Shoulder System | 2013 | 9 |
| K190911 | Physica KR Liner and SMR Reverse Humeral Liner | 2019 | 8 |
| K200368 | LINK Embrace Shoulder System - Reverse Configuration | 2021 | 3 |
| K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | 2022 | 2 |
| K172456 | Bone Screws 6.5mm | 2018 | 1 |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA… | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2016 | Class II | Z-1711-2016 | Component design/selection | Complaints of intra-operative breakage of the glenosphere impactors/extractors. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 9 of the 30 ancestors have a recall of any class.
- Of its descendants, K113254 (Lima Corporate S.P.A., 2012) has gone furthest, with 31 descendants of its own.
- 5 other devices also cite its predicate K081016.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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.
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 components are intended for use in cemented and uncemented applications, as specified in the following table:
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/K110598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110598: SMR Reverse 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/K110598
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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