510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw

K073688510(k) SpecialCleared Feb 29, 200863-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

Exactech, Inc. · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Feb 29, 2008 as substantially equivalent to K063569 (Exactech, Inc., 2007) after a 63-day review. Its family tree reaches back 9 generations to 1991. 1 of the 218 devices in its family, counting itself, has a Class I recall. 177 later devices descend from it. It has been recalled once.

Decided
Feb 29, 2008
Review
63 days
Class
Class II
Product code
PHX
Recalls
1
Predicates
1

Its longest line of descent runs back 9 generations to K911686 (1991). 40 ancestors in all, the oldest K790987 (1979). 177 later devices descend from it, 4 citing it directly. 1 of the 218 devices in this family, counting this one, has a Class I recall.

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 ancestor2010: 3 descendants cleared2012: 6 descendants cleared2015: 5 descendants cleared2008: 1 descendant cleared, 1 with a Class I recall12021: 21 descendants cleared2013: 8 descendants cleared2024: 13 descendants cleared2011: 3 descendants cleared2023: 13 descendants cleared2017: 10 descendants cleared2018: 9 descendants cleared2026: 18 descendants cleared2020: 13 descendants cleared2025: 15 descendants cleared2014: 6 descendants cleared2022: 16 descendants cleared2016: 4 descendants cleared2019: 13 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 descendants, 1 with a Class I recall12 generations forward: 31 descendants3 generations forward: 34 descendants4 generations forward: 28 descendants5 generations forward: 24 descendants6 generations forward: 29 descendants7 generations forward: 21 descendants8 generations forward: 6 descendants 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 deviceK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008
  7. Descendant · cites it directly · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  8. Descendant · 2 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  9. Descendant · 3 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  10. Descendant · 4 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  11. Descendant · 2 generations on · 69 of its ownK120121 Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc. · 2012 · Recalled
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 deviceK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008

Showing 5 of 177 descendants. See all descendants

Descendants cleared per year

2008: 12010: 32011: 32012: 62013: 82014: 62015: 52016: 42017: 102018: 92019: 132020: 132021: 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 177 · 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
−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)K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.2008—
+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
198710
198910
199210
199310
199520
199640
199820
199930
200010
200120
200310
200410
200550
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200811
201030
201130
201260
201380
201460
201550
201640
2017100
201890
2019130
2020130
2021210
2022160
2023130
2024130
2025150
2026180
FIG. 1 — Lineage of K073688, 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? (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 5
…888.3660, Class 11, Product Code KWS) Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or Proprietaar or Model Name Manufacturer K063569 Exactech Equinoxe' " Reverse Shoulder System Exactech, Inc. Indications for Use: The Exactech Equinoxe™ Reverse Shoulder System…
Exactech, Inc.200713

Also cleared against K063569: 15 other devices →

What descends from it? (177)

See all 177

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

NumberDeviceApplicantDecidedDescendants
K080642Comprehensive Reverse Shoulder Class IBiomet, Inc.2008172
K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210
K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154
K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.20102

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 15, 2012Class IIZ-2118-2012Labeling False and MisleadingExactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that…

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 17 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, K080642 (Biomet, Inc., 2008) has gone furthest, with 172 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. 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 Exactech Equinoxe™ Reverse Shoulder System is indicated to relieve pain and restore

function in skeletally mature individuals with degenerative diseases of the glenchumeral joint and

a grossly deficient, irreparable rotator cuff. The Equinoxe™ Reverse Shoulder is also indicated for

falled 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/K073688 · printed Nov 5, 2026

Cite this page

510(k) Report. “K073688: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073688

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