510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral Liner

K093275510(k) SpecialCleared May 27, 2010220-day reviewClass II21 CFR 888.3660Recalls 3

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

Exactech, Inc. · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on May 27, 2010 as substantially equivalent to K063569 (Exactech, Inc., 2007) after a 220-day review. Its family tree reaches back 9 generations to 1991. 31 later devices descend from it. It has been recalled 3 times.

Decided
May 27, 2010
Review
220 days
Class
Class II
Product code
PHX
Recalls
3
Predicates
1

Its longest line of descent runs back 9 generations to K911686 (1991). 40 ancestors in all, the oldest K790987 (1979). 31 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 2 other ancestors2005: 5 other ancestors2004: 1 other ancestor2003: 1 other ancestor2000: 1 other ancestor1999: 3 other ancestors1995: 2 other ancestors2001: 2 other ancestors1998: 2 other ancestors1980: 2 other ancestors1996: 4 other ancestors1993: 1 other ancestor1992: 1 other ancestor1989: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestor1979: 1 other ancestor2018: 3 descendants cleared2011: 1 descendant cleared2020: 2 descendants cleared2023: 6 descendants cleared2017: 1 descendant cleared2013: 1 descendant cleared2026: 5 descendants cleared2025: 5 descendants cleared2019: 1 descendant cleared2021: 2 descendants cleared2024: 2 descendants cleared2022: 2 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 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 7 other ancestors3 generations back: 6 other ancestors4 generations back: 7 other ancestors5 generations back: 11 other ancestors 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 7 descendants4 generations forward: 4 descendants5 generations forward: 3 descendants6 generations forward: 3 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant K063569 · 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. · 1991−50+5
  1. Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 5 generations between
  3. 3 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  4. 2 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  5. 1 generation backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  6. This deviceK093275 Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and…Exactech, Inc. · 2010
  7. Descendant · cites it directly · 30 of its ownK110708 Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM…Exactech, Inc. · 2011
  8. Descendant · 2 generations on · 20 of its ownK172502 Comprehensive Augmented Glenoid Components, Comprehensive Standard…Biomet Manufacturing Corp · 2018 · Recalled
  9. Descendant · 3 generations on · 12 of its ownK191746 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019
  10. Descendant · 3 generations on · 11 of its ownK200171 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020
  11. Descendant · 4 generations on · 8 of its ownK210717 Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021
Show all 9 generations
  1. Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 8 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 7 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 6 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 5 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 4 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 3 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 2 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 1 generation backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. This deviceK093275 Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and…Exactech, Inc. · 2010

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2011: 12013: 12017: 12018: 32019: 12020: 22021: 22022: 22023: 62024: 22025: 52026: 5
2011high 6 (2023) · low 0 (2012)2026

Most influential descendants

Showing 5 of 31 · See all
  • K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc. · 2011 · cites it directly30descendants
  • K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp · 2018 · 2 generations on20descendants
  • K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019 · 3 generations on12descendants
  • K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020 · 3 generations on11descendants
  • K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021 · 4 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−8K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−7K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−6K021478Delta ShoulderDepuy, Inc.2003—
−5K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−4K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−3K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−2K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−1K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
0 (this device)K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010—
+1K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere /…Exactech, Inc.2011—
+2K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp20181
+3K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.2019—
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.2020—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198710
198910
199210
199310
199520
199640
199820
199930
200010
200120
200310
200410
200550
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201310
201710
201830
201910
202020
202120
202220
202360
202420
202550
202650
FIG. 1 — Lineage of K093275, 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? (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
*K063569Equinoxe Reverse Shoulder System
Summary page 4
…88.3660, Class I, Product Code KWS) Information on devices to which Substantial equivalence is claimed: 510(k) Trade or Proprietary or Model Name Manufacturer Number ' K063569 Equinoxe Reverse Shoulder System Exactech, Inc. Indications for Use: koq3235 (2/3) Exactech® Equinoxe® Reverse…
Exactech, Inc.200713

Also cleared against K063569: 15 other devices →

What descends from it? (31)

See all 31

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

NumberDeviceApplicantDecidedDescendants
K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130
K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.20185
K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.20232
K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 6, 2024Class IIZ-1417-2024Nonconforming Material/ComponentThe packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer…
Mar 6, 2024Class IIZ-1416-2024Nonconforming Material/ComponentThe packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer…
Nov 21, 2023Class IIZ-0579-2024Packaging change controlExactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 9 months on median.
  • 13 of the 40 ancestors have a recall of any class.
  • Of its descendants, K110708 (Exactech, Inc., 2011) has gone furthest, with 30 descendants of its own.
  • 15 other devices also cite its predicate K063569.

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. 2010, 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 Equiinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

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 K063569

15 other devices cite the same predicate.

  • K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc. · 2024
  • K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc. · 20231 recall
  • K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc. · 2020
  • K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc. · 20191 recall
  • K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners…Exactech, Inc. · 20183 recalls
  • K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc. · 20183 recalls

More from Exactech, Inc.

207 FDA decisions under this applicant name. See the company

  • K260583Equinoxe® Shoulder SystemExactech, Inc. · 2026
  • K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc. · 2025
  • K243448Equinoxe® Shoulder SystemExactech, Inc. · 2025
  • K243275Equinoxe® Scapula Fracture SystemExactech, Inc. · 2025
  • K243839Alteon® HA Femoral StemsExactech, Inc. · 2025

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/K093275 · printed Nov 5, 2026

Cite this page

510(k) Report. “K093275: Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093275

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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