510(k) Report

510(k) · Cleared

Recalled · Class I · 2020

Comprehensive Reverse Shoulder

K080642510(k) TraditionalCleared Jul 9, 2008125-day reviewClass II21 CFR 888.3660Recalls 17 (1 Class I)

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

Biomet, Inc. · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Jul 9, 2008 as substantially equivalent to K072804 (Biomet Manufacturing Corp, 2007) and 6 other predicates after a 125-day review. Its family tree reaches back 10 generations to 1991. 1 of the 224 devices in its family, counting itself, has a Class I recall. 172 later devices descend from it. It has been recalled 17 times, including a Class I recall.

Decided
Jul 9, 2008
Review
125 days
Class
Class II
Product code
PHX
Recalls
17 (1 Class I)
Predicates
7

Its longest line of descent runs back 10 generations to K911686 (1991). 51 ancestors in all, the oldest K790987 (1979). 172 later devices descend from it, 24 citing it directly. 1 of the 224 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 2 other ancestors2005: 6 other ancestors2004: 1 other ancestor2003: 2 other ancestors1999: 4 other ancestors2001: 3 other ancestors2000: 2 other ancestors1998: 3 other ancestors1995: 2 other ancestors1994: 1 other ancestor1992: 2 other ancestors1987: 2 other ancestors1996: 4 other ancestors1993: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor1980: 2 other ancestors1979: 1 other ancestor2021: 21 descendants cleared2013: 8 descendants cleared2024: 13 descendants cleared2010: 3 descendants cleared2011: 3 descendants cleared2023: 13 descendants cleared2012: 5 descendants cleared2017: 9 descendants cleared2018: 9 descendants cleared2026: 18 descendants cleared2020: 13 descendants cleared2014: 6 descendants cleared2022: 16 descendants cleared2016: 4 descendants cleared2019: 13 descendants cleared2025: 15 descendants cleared2015: 3 descendants 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 · recalledK073688 · Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw · Exactech, Inc. · 2008 · recalled19801990200020102020
  1. Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 6 generations between
  3. 3 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  4. 2 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  5. 1 generation backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  6. This deviceK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008
  7. Descendant · cites it directly · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  8. Descendant · 2 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  9. Descendant · 3 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  10. Descendant · cites it directly · 69 of its ownK120121 Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc. · 2012 · Recalled
  11. Descendant · cites it directly · 61 of its ownK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
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 backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 5 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 4 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 3 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 2 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 1 generation backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. This deviceK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008

Showing 5 of 172 descendants. See all descendants

Descendants cleared per year

2010: 32011: 32012: 52013: 82014: 62015: 32016: 42017: 92018: 92019: 132020: 132021: 212022: 162023: 132024: 132025: 152026: 18
2010high 21 (2021) · low 3 (2010)2026

Most influential descendants

Showing 5 of 172 · See all
  • K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · cites it directly108descendants
  • K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on97descendants
  • K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · 3 generations on96descendants
  • K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc. · 2012 · cites it directly69descendants
  • K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010 · cites it directly61descendants
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—
−6K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−5K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−4K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−3K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−2K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−1K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
0 (this device)K080642Comprehensive Reverse ShoulderBiomet, Inc.2008—
+1K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
+2K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
+3K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
+1K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.20124
+1K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198720
198910
199220
199310
199410
199520
199640
199830
199940
200020
200130
200320
200410
200560
200620
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201030
201130
201250
201380
201460
201530
201640
201790
201890
2019130
2020130
2021210
2022160
2023130
2024130
2025150
2026180
FIG. 1 — Lineage of K080642, 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.

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? (7)

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
*K072804Comprehensive RS Shoulder System
Summary page 4
…, semi-constrained, cemented prosthesis (21 CFR 888.3660) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Comprehensive® RS Shoulder Biomet, Inc. K072804 Anatomical Shoulder™ Inverse/Reverse Zimmer, Inc. K053274 Equinoxe® Reverse Shoulder System Exactech K063569, KO73688 Encore Rev…
Biomet Manufacturing Corp2007—
*K053274Anatomical Shoulder Inverse/Reverse
Summary page 4
…Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Comprehensive® RS Shoulder Biomet, Inc. K072804 Anatomical Shoulder™ Inverse/Reverse Zimmer, Inc. K053274 Equinoxe® Reverse Shoulder System Exactech K063569, KO73688 Encore Reverse Shoulder Prosthesis Encore Medical K041066, K051075 Tr…
Zimmer GmbH20063
*K063569Equinoxe Reverse Shoulder System
Summary page 4
…alence Is Claimed: Comprehensive® RS Shoulder Biomet, Inc. K072804 Anatomical Shoulder™ Inverse/Reverse Zimmer, Inc. K053274 Equinoxe® Reverse Shoulder System Exactech K063569, KO73688 Encore Reverse Shoulder Prosthesis Encore Medical K041066, K051075 Trabecular Metal™ Reverse Shoulder Zimmer, Inc. K0529…
Exactech, Inc.200713
*K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
*K041066Encore Reverse Shoulder Prosthesis
Summary page 4
…Anatomical Shoulder™ Inverse/Reverse Zimmer, Inc. K053274 Equinoxe® Reverse Shoulder System Exactech K063569, KO73688 Encore Reverse Shoulder Prosthesis Encore Medical K041066, K051075 Trabecular Metal™ Reverse Shoulder Zimmer, Inc. K052906 Device Description: The Comprehensive® Reverse Shoulder is inte…
Encore Medical L.P.20054
*K051075Encore Reverse Shoulder Prosthesis
Summary page 4
…al Shoulder™ Inverse/Reverse Zimmer, Inc. K053274 Equinoxe® Reverse Shoulder System Exactech K063569, KO73688 Encore Reverse Shoulder Prosthesis Encore Medical K041066, K051075 Trabecular Metal™ Reverse Shoulder Zimmer, Inc. K052906 Device Description: The Comprehensive® Reverse Shoulder is intended for…
Encore Medical L.P.20055
*K052906Zimmer Trabecular Metal Reverse Shoulder System
Summary page 4
…oxe® Reverse Shoulder System Exactech K063569, KO73688 Encore Reverse Shoulder Prosthesis Encore Medical K041066, K051075 Trabecular Metal™ Reverse Shoulder Zimmer, Inc. K052906 Device Description: The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configu…
Zimmer, Inc.200512

Also cleared against K072804: 2 other devices →

What descends from it? (172)

See all 172

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

NumberDeviceApplicantDecidedDescendants
K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108
K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.201269
K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061
K120174Deput Delta Xtend Reverse ShoulderDepuy France201241
K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235
K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131
K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp201325
K193373Comprehensive® Reverse ShoulderBiomet, Inc.202020
K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp201820
K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 17, 2020Class IIZ-2144-2020Process controlPotential presence of elevated endotoxin levels that exceed the specification limit
Mar 13, 2020Class IIZ-1750-2020Under Investigation by firmThere were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
Feb 17, 2017Class IIZ-1859-2017Process designEndotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Dec 20, 2016Class IZ-1103-2017Device DesignHigher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
May 15, 2013Class IIZ-1548-2013Device DesignBiomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin…
Apr 22, 2011Not classifiedZ-2541-2011Employee errorThe firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.
Apr 22, 2011Not classifiedZ-2544-2011Employee errorThe firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.
Apr 22, 2011Not classifiedZ-2548-2011Employee errorThe firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.
Apr 22, 2011Not classifiedZ-2549-2011Employee errorThe firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.
Apr 22, 2011Not classifiedZ-2547-2011Employee errorThe firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.
Apr 22, 2011Not classifiedZ-2546-2011Employee errorThe firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.
Apr 22, 2011Not classifiedZ-2545-2011Employee errorThe firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.
Apr 22, 2011Not classifiedZ-2550-2011Employee errorThe firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.
Apr 22, 2011Not classifiedZ-2542-2011Employee errorThe firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.
Apr 22, 2011Not classifiedZ-2543-2011Employee errorThe firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.
Sep 13, 2010Not classifiedZ-0712-2011PendingThe firm received complaints regarding fracturing of the device.
Sep 13, 2010Not classifiedZ-0713-2011PendingThe firm received complaints regarding fracturing of the device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 9 months on median.
  • 17 of the 51 ancestors have a recall of any class.
  • Of its descendants, K110599 (Tornier, Inc., 2011) has gone furthest, with 108 descendants of its own.
  • 2 other devices also cite its predicate K072804.

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. 2008, 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 Comprehensive® Reverse Shoulder is 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…

Read the full statement (154 words)

The Comprehensive® Reverse Shoulder is 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.

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.

Intertok® 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 biological fixation applications.

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

Cite this page

510(k) Report. “K080642: Comprehensive Reverse Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080642

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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