510(k) Report

510(k) · Cleared

Cleared

Limacorporate SMR Reverse Shoulder System

K113523510(k) SpecialCleared Dec 20, 201121-day reviewClass II21 CFR 888.3660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lima Corporate S.P.A. · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Dec 20, 2011 as substantially equivalent to K110598 (Lima Corporate S.P.A., 2011) after a 21-day review. Its family tree reaches back 10 generations to 1991. 10 later devices descend from it.

Decided
Dec 20, 2011
Review
21 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K911686 (1991). 31 ancestors in all, the oldest K800494 (1980). 10 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2006: 1 other ancestor2007: 1 other ancestor2005: 1 other ancestor2004: 3 other ancestors2003: 1 other ancestor2001: 3 other ancestors1999: 4 other ancestors1995: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1980: 2 other ancestors1992: 1 other ancestor2013: 1 descendant cleared2016: 1 descendant cleared2018: 2 descendants cleared2019: 1 descendant cleared2022: 1 descendant cleared2024: 2 descendants cleared2021: 1 descendant cleared2025: 1 descendant clearedK911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K021478 · Delta Shoulder · Depuy, Inc. · 2003×2: 2 generations cleared close together, K062116 (2006), K062250 (2007) ×2: 2 generations cleared close together, K071379 (2007), K073676 (2008) K091751 · Depuy Delta Xtend Reverse Shoulder XLK Cup · DePuy Orthopaedics, Inc. · 2009K110598 · SMR Reverse Shoulder System · Lima Corporate S.P.A. · 2011 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 4 other ancestors4 generations back: 8 other ancestors5 generations back: 6 other ancestors6 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 4 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K110598 · SMR Reverse Shoulder System · Lima Corporate S.P.A. · 2011 · recalledK091751 · Depuy Delta Xtend Reverse Shoulder XLK Cup · DePuy Orthopaedics, Inc. · 2009K073676 · Depuy Delta Xtend Reverse Shoulder High Mobility Cup · DePuy Orthopaedics, Inc. · 2008K071379 · Delta Xtend Reverse Shoulder Modular Stem · DePuy Orthopaedics, Inc. · 2007K062250 · Delta Xtend Reverse Shoulder System · DePuy Orthopaedics, Inc. · 2007 · recalledK062116 · Delta Cta Reverse Shoulder System Humeral Heads · DePuy Orthopaedics, Inc. · 2006K021478 · Delta Shoulder · Depuy, Inc. · 2003K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991−10−50+5
  1. Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 6 generations between
  3. 3 generations backK073676 Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc. · 2008
  4. 2 generations backK091751 Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc. · 2009
  5. 1 generation backK110598 SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011 · Recalled
  6. This deviceK113523 Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011
  7. Descendant · cites it directly · 9 of its ownK130050 Titan Reverse Shoulder SystemAscension Orthopedic · 2013
  8. Descendant · 2 generations on · 8 of its ownK161189 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2016
  9. Descendant · 3 generations on · 4 of its ownK190588 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2019
  10. Descendant · 3 generations on · 3 of its ownK173717 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018
  11. Descendant · 4 generations on · 2 of its ownK181999 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018
Show all 10 generations
  1. Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 9 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 8 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 7 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 6 generations backK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
  6. 5 generations backK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
  7. 4 generations backK071379 Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc. · 2007
  8. 3 generations backK073676 Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc. · 2008
  9. 2 generations backK091751 Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc. · 2009
  10. 1 generation backK110598 SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011 · Recalled
  11. This deviceK113523 Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2013: 12016: 12018: 22019: 12021: 12022: 12024: 22025: 1
2013high 2 (2018) · low 0 (2014)2026

Most influential descendants

Showing 5 of 10 · See all
  • K130050Titan Reverse Shoulder SystemAscension Orthopedic · 2013 · cites it directly9descendants
  • K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2016 · 2 generations on8descendants
  • K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2019 · 3 generations on4descendants
  • K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018 · 3 generations on3descendants
  • K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−9K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−8K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−7K021478Delta ShoulderDepuy, Inc.2003—
−6K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc.2006—
−5K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20078
−4K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc.2007—
−3K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc.2008—
−2K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc.2009—
−1K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.20111
0 (this device)K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.2011—
+1K130050Titan Reverse Shoulder SystemAscension Orthopedic2013—
+2K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation2016—
+3K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation2019—
+3K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation2018—
+4K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198020
199210
199510
199810
199940
200010
200130
200310
200430
200510
200610
200710
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201610
201820
201910
202110
202210
202420
202510
FIG. 1 — Lineage of K113523, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K110598SMR Reverse Shoulder System
Summary page 4
…er | KWS Shoulder joint metal/polymer semi-constrained System cemented prosthesis per 21 CFR 888.3660 Description: The SMR Reverse Shoulder System (cleared via 510(k): K110598) consists of a humeral stem, a reverse humeral body, a reverse liner, a metal-back glenoid, a glenosphere and a connector with sc…
Lima Corporate S.P.A.20111

Also cleared against K110598: 11 other devices →

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130050Titan Reverse Shoulder SystemAscension Orthopedic20139

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

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.
  • 10 of the 31 ancestors have a recall of any class.
  • Of its descendants, K130050 (Ascension Orthopedic, 2013) has gone furthest, with 9 descendants of its own.
  • 11 other devices also cite its predicate K110598.

How does its category compare?

All PHX devices

PHX 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

2007: 52008: 62009: 12010: 82011: 122012: 122013: 82014: 122015: 42016: 42017: 112018: 142019: 92020: 132021: 212022: 92023: 92024: 92025: 92026 (partial year): 18
2007high 21 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PHX

72in 2025

2007: 97 days median2008: 79 days median2010: 124 days median2011: 94 days median2012: 114 days median2013: 143 days median2014: 110 days median2015: 206 days median2016: 132 days median2017: 141 days median2018: 127 days median2019: 144 days median2020: 143 days median2021: 143 days median2022: 198 days median2023: 154 days median2024: 139 days median2025: 72 days median2026 (partial year): 130 days median
2007high 206 (2015) · low 72 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PHX

3in 2025

2015: 22018: 12019: 32020: 32021: 82023: 72024: 12025: 32026 (partial year): 7
2007high 8 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PHX

2,848in 2025

2015: 142016: 52017: 252018: 3232019: 5042020: 9862021: 1,4042022: 1,3422023: 1,4012024: 2,1422025: 2,848
2007high 2,848 (2025) · low 0 (2007)2025

MAUDE reports naming product code PHX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200759700
200867900
20091—00
2010812400
2011129400
20121211400
2013814300
20141211000
20154206214
2016413205
201711141025
2018141271323
201991443504
2020131433986
20212114381,404
2022919801,342
2023915471,401
2024913912,142
202597232,848
2026181307—

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 SMR Reverse Shoulder System humeral bodies, cemented non-finned humeral stems and cemented revision stems are intended…

Read the full statement (112 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.

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 Reverse Shoulder System humeral bodies, cemented non-finned humeral stems and cemented revision stems are intended for cemented use. The SMR Reverse Shoulder System humeral bodies, finned humeral stems and uncemented revision stems are intended for cementless use. The SMR Reverse Shoulder System metal-backed glenoids and glenospheres are intended for uncemented press-fit use only with the addition of screws for fixation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K110598

11 other devices cite the same predicate.

  • K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA…Encore Medical L.P. · 2025
  • K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 20222 recalls
  • K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021
  • K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021
  • K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
  • K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A. · 2019

More from Lima Corporate S.P.A.

64 FDA decisions under this applicant name. See the company

  • K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A. · 2026
  • K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A. · 2025
  • K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 2025
  • K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A. · 2025
  • K243615Physica Porous Femoral ComponentsLima Corporate S.P.A. · 2024

Recent decisions in PHX

The PHX category page

  • K263421Veritas Shoulder Systemrestor3d, inc. · 2026
  • K263086AltiVate Reverse® Glenosphere with RAVN™ TechnologyEncore Medical L.P. · 2026
  • K260556Veritas Shoulder SystemRestor3D · 2026
  • K261683Augment Off-Axis Instrument SystemZimmer, Inc. · 2026
  • K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.) · 2026

https://510kreport.com/device/K113523 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113523: Limacorporate 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/K113523

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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