510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate

K172502510(k) TraditionalCleared Jan 3, 2018138-day reviewClass II21 CFR 888.3660Recalls 1

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

Biomet Manufacturing Corp · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Jan 3, 2018 as substantially equivalent to K120121 (Biomet, Inc., 2012) and 3 other predicates after a 138-day review. Its family tree reaches back 13 generations to 1991. 1 of the 97 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it. It has been recalled once.

Decided
Jan 3, 2018
Review
138 days
Class
Class II
Product code
PHX
Recalls
1
Predicates
4

Its longest line of descent runs back 13 generations to K911686 (1991). 76 ancestors in all, the oldest K790987 (1979). 20 later devices descend from it, 6 citing it directly. 1 of the 97 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2011: 1 other ancestor2010: 1 other ancestor2008: 2 other ancestors2007: 1 other ancestor2006: 4 other ancestors2005: 7 other ancestors2003: 2 other ancestors2004: 1 other ancestor2001: 3 other ancestors2000: 5 other ancestors1999: 4 other ancestors1998: 3 other ancestors1994: 6 other ancestors1992: 2 other ancestors1987: 2 other ancestors2002: 2 other ancestors1997: 1 other ancestor1996: 6 other ancestors1995: 2 other ancestors1993: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor1980: 2 other ancestors1979: 1 other ancestor2023: 5 descendants cleared2020: 1 descendant cleared2019: 1 descendant cleared2026: 4 descendants cleared2021: 2 descendants cleared2025: 4 descendants cleared2022: 2 descendants cleared2024: 1 descendant clearedK911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991×2: 2 generations cleared close together, K984541 (1999), K992065 (1999) ×3: 3 generations cleared close together, K021478 (2003), K030941 (2004), K041873 (2004) ×2: 2 generations cleared close together, K052906 (2005), K060704 (2006) K063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalled×2: 2 generations cleared close together, K073688 (2008), K080642 (2008) K093803 · Bio-Modular Reverse Sholder · Biomet Manufacturing Corp · 2010K131353 · Comprehensive Reverse Shoulder - Titanium Glenosphere · Biomet Manufacturing Corp · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors3 generations back: 20 other ancestors4 generations back: 14 other ancestors5 generations back: 20 other ancestors 1 generation forward: 6 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K131353 · Comprehensive Reverse Shoulder - Titanium Glenosphere · Biomet Manufacturing Corp · 2013K093803 · Bio-Modular Reverse Sholder · Biomet Manufacturing Corp · 2010K080642 · Comprehensive Reverse Shoulder · Biomet, Inc. · 2008 · Class I recallK073688 · Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw · Exactech, Inc. · 2008 · recalledK063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalledK060704 · Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM · Zimmer, Inc. · 2006 · recalledK052906 · Zimmer Trabecular Metal Reverse Shoulder System · Zimmer, Inc. · 2005 · recalledK041873 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K030941 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K021478 · 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 · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 9 generations between
  3. 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  4. 2 generations backK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
  5. 1 generation backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
  6. This deviceK172502 Comprehensive Augmented Glenoid Components, Comprehensive Standard…Biomet Manufacturing Corp · 2018
  7. Descendant · cites it directly · 12 of its ownK191746 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019
  8. Descendant · cites it directly · 11 of its ownK200171 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020
  9. Descendant · 2 generations on · 8 of its ownK210717 Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021
  10. Descendant · 3 generations on · 7 of its ownK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
  11. Descendant · 4 generations on · 3 of its ownK223876 SMR Shoulder SystemLima Corporate S.P.A. · 2023
Show all 13 generations
  1. Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 12 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 11 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 10 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 9 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 8 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 7 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 6 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 5 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 4 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 2 generations backK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
  13. 1 generation backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
  14. This deviceK172502 Comprehensive Augmented Glenoid Components, Comprehensive Standard…Biomet Manufacturing Corp · 2018

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2019: 12020: 12021: 22022: 22023: 52024: 12025: 42026: 4
2019high 5 (2023) · low 1 (2019)2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulderdirect predicate · 2008

Most influential descendants

Showing 5 of 20 · See all
  • K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019 · cites it directly12descendants
  • K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020 · cites it directly11descendants
  • K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021 · 2 generations on8descendants
  • K220792SMR Reverse LinerLima Corporate S.P.A. · 2022 · 3 generations on7descendants
  • K223876SMR Shoulder SystemLima Corporate S.P.A. · 2023 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−12K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−11K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−10K021478Delta ShoulderDepuy, Inc.2003—
−9K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−8K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−7K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−6K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−5K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−4K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−3K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−2K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp2010—
−1K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp2013—
0 (this device)K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018—
+1K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.2019—
+1K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.2020—
+2K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.2021—
+3K220792SMR Reverse LinerLima Corporate S.P.A.2022—
+4K223876SMR Shoulder SystemLima Corporate S.P.A.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198720
198910
199110
199220
199310
199460
199520
199660
199710
199830
199940
200050
200130
200220
200320
200410
200570
200640
200710
200820
201010
201110
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202010
202120
202220
202350
202410
202540
202640
FIG. 1 — Lineage of K172502, 1991–2026Source: 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.

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. #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? (4)

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
*K120121Comprehensive Reverse Shoulder-Mini Baseplate
Summary page 4
…evice(s): Device Manufacturer 510(k) Number Comprehensive Reverse Shoulder –Mini Biomet, Inc. K120121 Baseplate Comprehensive Reverse Shoulder Biomet, Inc. K080642 Equinoxe Reverse Total…
Biomet, Inc.20124
*K080642Comprehensive Reverse Shoulder
Summary page 4
…Comprehensive Reverse Shoulder –Mini Biomet, Inc. K120121 Baseplate Comprehensive Reverse Shoulder Biomet, Inc. K080642 Equinoxe Reverse Total Shoulder System Exactech, Inc. K110708 Comprehensive Reverse Shoulder – Titaniu…
Biomet, Inc.2008Class I
*K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…
Summary page 4
…Baseplate Comprehensive Reverse Shoulder Biomet, Inc. K080642 Equinoxe Reverse Total Shoulder System Exactech, Inc. K110708 Comprehensive Reverse Shoulder – Titanium Biomet, Inc K131353 Glenosphere…
Exactech, Inc.2011—
*K131353Comprehensive Reverse Shoulder - Titanium Glenosphere
Summary page 4
…K080642 Equinoxe Reverse Total Shoulder System Exactech, Inc. K110708 Comprehensive Reverse Shoulder – Titanium Biomet, Inc K131353 Glenosphere K172502 p. 2/3 P…
Biomet Manufacturing Corp2013—

Also cleared against K120121: 8 other devices →

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912
K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011
K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213
K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231
K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260
K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 21, 2019Class IIZ-0520-2020Environmental controlElevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
  • 25 of the 76 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K191746 (Lima Corporate S.P.A., 2019) has gone furthest, with 12 descendants of its own.
  • 8 other devices also cite its predicate K120121.

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. 2018, 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?

Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or…

Read the full statement (212 words)

Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biclogical fixation applications.

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 K120121

8 other devices cite the same predicate.

  • K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics · 2026
  • K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2023
  • K213459Glenoid Reconstruction SystemMedacta International S.A. · 2022
  • K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2021
  • K193373Comprehensive® Reverse ShoulderBiomet, Inc. · 20202 recalls
  • K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp · 20161 recall

More from Biomet Manufacturing Corp

201 FDA decisions under this applicant name. See the company

  • P010014/S119Cementless Oxford Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S118Oxford Partial Knee Anatomic Vivacit-E Meniscal BearingsBiomet Manufacturing Corp · 2026
  • P010014/S117Oxford™ Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S112Oxford Partial Knee System; Cementless Oxford™Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S116Oxford® Partial Knee SystemBiomet Manufacturing Corp · 2026

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/K172502 · printed Nov 5, 2026

Cite this page

510(k) Report. “K172502: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172502

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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