510(k) Report

510(k) · Cleared

Cleared

Comprehensive RS Shoulder System

K072804510(k) TraditionalCleared Dec 12, 200772-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

Biomet Manufacturing Corp · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Dec 12, 2007 as substantially equivalent to K021478 (Depuy, Inc., 2003) and 9 other predicates after a 72-day review. Its family tree reaches back 7 generations to 1991. 1 of the 214 devices in its family, counting itself, has a Class I recall. 175 later devices descend from it.

Decided
Dec 12, 2007
Review
72 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
10

Its longest line of descent runs back 7 generations to K911686 (1991). 38 ancestors in all, the oldest K790987 (1979). 175 later devices descend from it, 3 citing it directly. 1 of the 214 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2005: 4 other ancestors2003: 1 other ancestor1999: 3 other ancestors2004: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1998: 3 other ancestors1995: 2 other ancestors1994: 1 other ancestor1992: 2 other ancestors1987: 2 other ancestors1980: 2 other ancestors1996: 4 other ancestors1993: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor1979: 1 other ancestor2013: 8 descendants cleared2017: 10 descendants cleared2008: 1 descendant cleared, 1 with a Class I recall12021: 21 descendants cleared2024: 13 descendants cleared2010: 3 descendants cleared2011: 3 descendants cleared2023: 13 descendants cleared2012: 5 descendants cleared2018: 9 descendants cleared2026: 18 descendants cleared2020: 14 descendants cleared2016: 4 descendants cleared2025: 15 descendants cleared2014: 6 descendants cleared2022: 16 descendants cleared2019: 13 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) K052906 · Zimmer Trabecular Metal Reverse Shoulder System · Zimmer, Inc. · 2005 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 12 other ancestors3 generations back: 3 other ancestors4 generations back: 10 other ancestors 1 generation forward: 3 descendants, 1 with a Class I recall12 generations forward: 32 descendants3 generations forward: 40 descendants4 generations forward: 27 descendants5 generations forward: 23 descendants6 generations forward: 28 descendants7 generations forward: 16 descendants8 generations forward: 6 descendants K052906 · 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. · 1991−50+5
  1. Root · 7 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 6 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 5 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 4 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 3 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 2 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 1 generation backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. This deviceK072804 Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007
  9. Descendant · cites it directly · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  10. Descendant · 2 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  11. Descendant · 3 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  12. Descendant · 4 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  13. Descendant · 2 generations on · 69 of its ownK120121 Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc. · 2012 · Recalled

Showing 5 of 175 descendants. See all descendants

Descendants cleared per year

2008: 12010: 32011: 32012: 52013: 82014: 62015: 32016: 42017: 102018: 92019: 132020: 142021: 212022: 162023: 132024: 132025: 152026: 18
2008high 21 (2021) · low 0 (2009)2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shouldercites it directly · 2008

Most influential descendants

Showing 5 of 175 · See all
  • K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · cites it directly172descendants
  • K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on108descendants
  • K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on97descendants
  • K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · 4 generations on96descendants
  • K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc. · 2012 · 2 generations on69descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−6K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−5K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−4K021478Delta ShoulderDepuy, Inc.2003—
−3K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−2K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−1K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
0 (this device)K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007—
+1K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
+2K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.20124

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198720
198910
199220
199310
199410
199520
199640
199830
199930
200010
200110
200310
200410
200540

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200811
201030
201130
201250
201380
201460
201530
201640
2017100
201890
2019130
2020140
2021210
2022160
2023130
2024130
2025150
2026180
FIG. 1 — Lineage of K072804, 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
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What was it cleared against? (10)

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
*K021478Delta Shoulder
Summary page 4
…ned, cemented prosthesis (21 C.F.R. 888.3660) KWS Legally Marketed Devices To Which Substantial Equivalence Is Claimed: ¢ Delta Shoulder and CTA™ Humeral Cups (DePuy) K021478, K0O50315 e Aequalis® Reversed Shoulder Prosthesis (Tomier) K030941, K041873 ¢ Encore reverse Shoulder Prosthesis (Encore) K041…
Depuy, Inc.2003—
*K050315Delta Humeral CupsDePuy Orthopaedics, Inc.2005—
*K030941Aequalis Reversed Shoulder Prosthesis
Summary page 4
…evices To Which Substantial Equivalence Is Claimed: ¢ Delta Shoulder and CTA™ Humeral Cups (DePuy) K021478, K0O50315 e Aequalis® Reversed Shoulder Prosthesis (Tomier) K030941, K041873 ¢ Encore reverse Shoulder Prosthesis (Encore) K041066, K051075 o Zimmer Trabecular Metal™ Reverse Shoulder System K052…
Tornier2004—
*K041873Aequalis Reversed Shoulder Prosthesis
Summary page 4
…Which Substantial Equivalence Is Claimed: ¢ Delta Shoulder and CTA™ Humeral Cups (DePuy) K021478, K0O50315 e Aequalis® Reversed Shoulder Prosthesis (Tomier) K030941, K041873 ¢ Encore reverse Shoulder Prosthesis (Encore) K041066, K051075 o Zimmer Trabecular Metal™ Reverse Shoulder System K052906 ¢ Bi…
Tornier2004—
*K041066Encore Reverse Shoulder Prosthesis
Summary page 4
…ulder and CTA™ Humeral Cups (DePuy) K021478, K0O50315 e Aequalis® Reversed Shoulder Prosthesis (Tomier) K030941, K041873 ¢ Encore reverse Shoulder Prosthesis (Encore) K041066, K051075 o Zimmer Trabecular Metal™ Reverse Shoulder System K052906 ¢ Bio-Modular® Shoulder System (Biomet) K992119, K030710, K…
Encore Medical L.P.20054
*K051075Encore Reverse Shoulder Prosthesis
Summary page 4
…CTA™ Humeral Cups (DePuy) K021478, K0O50315 e Aequalis® Reversed Shoulder Prosthesis (Tomier) K030941, K041873 ¢ Encore reverse Shoulder Prosthesis (Encore) K041066, K051075 o Zimmer Trabecular Metal™ Reverse Shoulder System K052906 ¢ Bio-Modular® Shoulder System (Biomet) K992119, K030710, K043100 D…
Encore Medical L.P.20055
*K052906Zimmer Trabecular Metal Reverse Shoulder System
Summary page 4
…eversed Shoulder Prosthesis (Tomier) K030941, K041873 ¢ Encore reverse Shoulder Prosthesis (Encore) K041066, K051075 o Zimmer Trabecular Metal™ Reverse Shoulder System K052906 ¢ Bio-Modular® Shoulder System (Biomet) K992119, K030710, K043100 Device Description: The Comprehensive® RS Shoulder System is…
Zimmer, Inc.200512
*K992119Bio-Modular Shoulder System
Summary page 4
…1873 ¢ Encore reverse Shoulder Prosthesis (Encore) K041066, K051075 o Zimmer Trabecular Metal™ Reverse Shoulder System K052906 ¢ Bio-Modular® Shoulder System (Biomet) K992119, K030710, K043100 Device Description: The Comprehensive® RS Shoulder System is intended for total shoulder replacement in a reve…
Biomet, Inc.19991
*K030710Bio-Modular Shoulder System
Summary page 4
…ncore reverse Shoulder Prosthesis (Encore) K041066, K051075 o Zimmer Trabecular Metal™ Reverse Shoulder System K052906 ¢ Bio-Modular® Shoulder System (Biomet) K992119, K030710, K043100 Device Description: The Comprehensive® RS Shoulder System is intended for total shoulder replacement in a reverse shoul…
Biomet, Inc.20031
*K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components
Summary page 4
…erse Shoulder Prosthesis (Encore) K041066, K051075 o Zimmer Trabecular Metal™ Reverse Shoulder System K052906 ¢ Bio-Modular® Shoulder System (Biomet) K992119, K030710, K043100 Device Description: The Comprehensive® RS Shoulder System is intended for total shoulder replacement in a reverse shoulder. Int…
Biomet, Inc.20051

Also cleared against K021478: 18 other devices →

What descends from it? (175)

See all 175

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

NumberDeviceApplicantDecidedDescendants
K080642Comprehensive Reverse Shoulder Class IBiomet, Inc.2008172
K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314
K170452Medacta Shoulder SystemMedacta International S.A.201712

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

No FDA recall names this device.

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 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
  • 11 of the 38 ancestors have a recall of any class.
  • Of its descendants, K080642 (Biomet, Inc., 2008) has gone furthest, with 172 descendants of its own.
  • 18 other devices also cite its predicate K021478.

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. 2007, 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® RS Shoulder System 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 deitoid muscle is necessary.

A cemented humeral stem must be used.

The MacroBond®/HA RS Cleats are indicated only for uncemented biological fixation applications. The GT Baseplate components are intended for cementless application with the additicn of screw 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 K021478

18 other devices cite the same predicate.

  • K202024ARROW Short Stem Humeral SystemFH Industrie · 2021
  • K203230Global Shoulder and Delta CTA systemsDepuy Lnc. · 2021
  • K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp. · 2013
  • K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture…Tornier · 2012
  • K103251Duocentric ReversedAston Medical · 2011
  • K082120Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008

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/K072804 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072804: Comprehensive RS 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/K072804

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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