510(k) Report

510(k) · Cleared

Cleared

SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws

K113254510(k) TraditionalCleared Feb 24, 2012113-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 Feb 24, 2012 as substantially equivalent to K110598 (Lima Corporate S.P.A., 2011) and 7 other predicates after a 113-day review. Its family tree reaches back 10 generations to 1991. 31 later devices descend from it.

Decided
Feb 24, 2012
Review
113 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
8

Its longest line of descent runs back 10 generations to K911686 (1991). 51 ancestors in all, the oldest K800494 (1980). 31 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 3 other ancestors2010: 1 other ancestor2008: 2 other ancestors2003: 2 other ancestors1999: 5 other ancestors2007: 1 other ancestor2006: 1 other ancestor2004: 3 other ancestors2001: 4 other ancestors2000: 3 other ancestors1998: 2 other ancestors1994: 1 other ancestor1992: 2 other ancestors1987: 3 other ancestors2005: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors1988: 1 other ancestor1980: 2 other ancestors2013: 1 descendant cleared2016: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2019: 3 descendants cleared2018: 1 descendant cleared2023: 6 descendants cleared2021: 5 descendants cleared2017: 2 descendants cleared2022: 3 descendants cleared2020: 1 descendant cleared2026: 2 descendants cleared2025: 3 descendants cleared2024: 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 1 generation back: 7 other ancestors2 generations back: 17 other ancestors3 generations back: 11 other ancestors4 generations back: 6 other ancestors 1 generation forward: 6 descendants2 generations forward: 6 descendants3 generations forward: 8 descendants4 generations forward: 3 descendants5 generations forward: 4 descendants6 generations forward: 3 descendants7 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 deviceK113254 SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular…Lima Corporate S.P.A. · 2012
  7. Descendant · cites it directly · 20 of its ownK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
  8. Descendant · cites it directly · 13 of its ownK153722 SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2016
  9. Descendant · 2 generations on · 12 of its ownK191746 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019
  10. Descendant · 2 generations on · 12 of its ownK163397 SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2017 · Recalled
  11. Descendant · 3 generations on · 11 of its ownK200171 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020
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 deviceK113254 SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular…Lima Corporate S.P.A. · 2012

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12015: 12016: 12017: 22018: 12019: 32020: 12021: 52022: 32023: 62024: 12025: 32026: 2
2013high 6 (2023) · low 1 (2013)2026

Most influential descendants

Showing 5 of 31 · See all
  • K133349SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014 · cites it directly20descendants
  • K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2016 · cites it directly13descendants
  • K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019 · 2 generations on12descendants
  • K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2017 · 2 generations on12descendants
  • K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020 · 3 generations on11descendants
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)K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular…Lima Corporate S.P.A.2012—
+1K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.2014—
+1K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.2016—
+2K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.2019—
+2K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.20171
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198020
198730
198810
199220
199410
199520
199610
199710
199820
199950
200030
200140
200320
200430
200510
200610
200710
200820
201010
201130

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201510
201610
201720
201810
201930
202010
202150
202230
202360
202410
202530
202620
FIG. 1 — Lineage of K113254, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (8)

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 5
…eplacement, is intended for uncemented use with the addition of screws for fixation. Predicate Devices: " SMR Reverse Shoulder System metal-back glenoid (Limacorporate, K1 10598), SMR Shoulder System (Limacorporate, K100858); SMR Uncemented Shoulder System (Limacorporate, K101263); SMR CTA Humeral Heads (L…
Lima Corporate S.P.A.20111
*K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…
Summary page 5
…the addition of screws for fixation. Predicate Devices: " SMR Reverse Shoulder System metal-back glenoid (Limacorporate, K1 10598), SMR Shoulder System (Limacorporate, K100858); SMR Uncemented Shoulder System (Limacorporate, K101263); SMR CTA Humeral Heads (Limacorporate, K110847); - SMR Revision Stems (…
Lima-Lto S.P.A.20102
*K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…
Summary page 5
…" SMR Reverse Shoulder System metal-back glenoid (Limacorporate, K1 10598), SMR Shoulder System (Limacorporate, K100858); SMR Uncemented Shoulder System (Limacorporate, K101263); SMR CTA Humeral Heads (Limacorporate, K110847); - SMR Revision Stems (Limacorporate, K111212); Bio-modular Shoulder System (Bio…
Lima-Lto S.P.A.2011—
*K110847SMR Shoulder System - Cta Humeral Heads
Summary page 5
…d (Limacorporate, K1 10598), SMR Shoulder System (Limacorporate, K100858); SMR Uncemented Shoulder System (Limacorporate, K101263); SMR CTA Humeral Heads (Limacorporate, K110847); - SMR Revision Stems (Limacorporate, K111212); Bio-modular Shoulder System (Biomet, K030710, K992119); Metal-backed Revision Gl…
Lima Corporate S.P.A.2011—
*K111212SMR Shoulder System- Revision Stems
Summary page 5
…m (Limacorporate, K100858); SMR Uncemented Shoulder System (Limacorporate, K101263); SMR CTA Humeral Heads (Limacorporate, K110847); - SMR Revision Stems (Limacorporate, K111212); Bio-modular Shoulder System (Biomet, K030710, K992119); Metal-backed Revision Glenoid (Encore - DJO, K081448). | Comparable Fe…
Lima Corporate S.P.A.2011—
*K030710Bio-Modular Shoulder System
Summary page 5
…lder System (Limacorporate, K101263); SMR CTA Humeral Heads (Limacorporate, K110847); - SMR Revision Stems (Limacorporate, K111212); Bio-modular Shoulder System (Biomet, K030710, K992119); Metal-backed Revision Glenoid (Encore - DJO, K081448). | Comparable Features to Predicate Device(s): The SMR Modular…
Biomet, Inc.20031
*K992119Bio-Modular Shoulder System
Summary page 5
…em (Limacorporate, K101263); SMR CTA Humeral Heads (Limacorporate, K110847); - SMR Revision Stems (Limacorporate, K111212); Bio-modular Shoulder System (Biomet, K030710, K992119); Metal-backed Revision Glenoid (Encore - DJO, K081448). | Comparable Features to Predicate Device(s): The SMR Modular Glenoid i…
Biomet, Inc.19991
*K081448Encore Shoulder Revision Glenoid
Summary page 5
…acorporate, K110847); - SMR Revision Stems (Limacorporate, K111212); Bio-modular Shoulder System (Biomet, K030710, K992119); Metal-backed Revision Glenoid (Encore - DJO, K081448). | Comparable Features to Predicate Device(s): The SMR Modular Glenoid is similar to the predicate devices in terms of intende…
Encore Medical L.P.20081

Also cleared against K110598: 11 other devices →

What descends from it? (31)

See all 31

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420
K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613
K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.20138
K172456Bone Screws 6.5mmLima Corporate S.P.A.20181
K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190
K143256SMR Modular GlenoidLima Corporate S.P.A.20150

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 21 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
  • 15 of the 51 ancestors have a recall of any class.
  • Of its descendants, K133349 (Lima Corporate S.P.A., 2014) has gone furthest, with 20 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. 2012, 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 Modular Glenoid is intended for use in total primary or revision shoulder joint replacement with either the SMR Anatomic Shoulder System or the SMR Reverse Shoulder system. The SMR Anatomic Shoulder System is indicated for 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…

Read the full statement (207 words)

The SMR Modular Glenoid is intended for use in total primary or revision shoulder joint replacement with either the SMR Anatomic Shoulder System or the SMR Reverse Shoulder system.

The SMR Anatomic Shoulder System is indicated for 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;

. Cuff tear arthropathy (CTA Heads only);

In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic

Shoulder Replacement, is intended for use with bone cement and should be used without bone

SCIEWS. :

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 (disabling

. 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 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.

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/K113254 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113254: SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113254

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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