510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Equinoxe Reverse Shoulder System

K063569510(k) TraditionalCleared Feb 23, 200786-day reviewClass II21 CFR 888.3660Recalls 13

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 23, 2007 as substantially equivalent to K021478 (Depuy, Inc., 2003) and 11 other predicates after an 86-day review. Its family tree reaches back 8 generations to 1991. 1 of the 230 devices in its family, counting itself, has a Class I recall. 190 later devices descend from it. It has been recalled 13 times.

Decided
Feb 23, 2007
Review
86 days
Class
Class II
Product code
PHX
Recalls
13
Predicates
12

Its longest line of descent runs back 8 generations to K911686 (1991). 39 ancestors in all, the oldest K790987 (1979). 190 later devices descend from it, 16 citing it directly. 1 of the 230 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 ancestor2017: 11 descendants cleared2010: 5 descendants cleared2018: 11 descendants cleared2012: 7 descendants cleared2008: 3 descendants cleared, 1 with a Class I recall12019: 14 descendants cleared2024: 13 descendants cleared2011: 4 descendants cleared2020: 14 descendants cleared2023: 13 descendants cleared2015: 6 descendants cleared2021: 21 descendants cleared2013: 9 descendants cleared2026: 18 descendants cleared2025: 15 descendants cleared2014: 6 descendants cleared2022: 16 descendants cleared2016: 4 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) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 6 other ancestors3 generations back: 7 other ancestors4 generations back: 11 other ancestors 1 generation forward: 16 descendants, 1 with a Class I recall12 generations forward: 33 descendants3 generations forward: 36 descendants4 generations forward: 28 descendants5 generations forward: 24 descendants6 generations forward: 29 descendants7 generations forward: 20 descendants8 generations forward: 4 descendants K060704 · 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 · 8 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 7 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 6 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 5 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 4 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 3 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 2 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 1 generation backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. This deviceK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007
  10. Descendant · cites it directly · 177 of its ownK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. Descendant · cites it directly · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. Descendant · 2 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. Descendant · 3 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  14. Descendant · 4 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled

Showing 5 of 190 descendants. See all descendants

Descendants cleared per year

2008: 32010: 52011: 42012: 72013: 92014: 62015: 62016: 42017: 112018: 112019: 142020: 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 190 · See all
  • K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc. · 2008 · cites it directly177descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−7K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−6K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−5K021478Delta ShoulderDepuy, Inc.2003—
−4K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−3K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−2K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−1K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
0 (this device)K063569Equinoxe Reverse Shoulder SystemExactech, Inc.2007—
+1K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
+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

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
200831
201050
201140
201270
201390
201460
201560
201640
2017110
2018110
2019140
2020140
2021210
2022160
2023130
2024130
2025150
2026180
FIG. 1 — Lineage of K063569, 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? (12)

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 1
…CER 888.3660, Class II, Product Code KWS) Legally Marketed Devices to Which Substantial Equivalence Is Claimed * Depuy Delta III Reverse Shoulder (#1(021478, #K050315, #K(062116) * Tornier Reverse Shoulder (#1(030941, #1(041873,41(050316) * Zimmer BF Reverse Shoulder…
Depuy, Inc.2003—
*K050315Delta Humeral Cups
Summary page 1
…3660, Class II, Product Code KWS) Legally Marketed Devices to Which Substantial Equivalence Is Claimed * Depuy Delta III Reverse Shoulder (#1(021478, #K050315, #K(062116) * Tornier Reverse Shoulder (#1(030941, #1(041873,41(050316) * Zimmer BF Reverse Shoulder (#K(052906…
DePuy Orthopaedics, Inc.2005—
*K062116Delta Cta Reverse Shoulder System Humeral Heads
Summary page 1
…II, Product Code KWS) Legally Marketed Devices to Which Substantial Equivalence Is Claimed * Depuy Delta III Reverse Shoulder (#1(021478, #K050315, #K(062116) * Tornier Reverse Shoulder (#1(030941, #1(041873,41(050316) * Zimmer BF Reverse Shoulder (#K(052906, #K060704)…
DePuy Orthopaedics, Inc.2006—
*K030941Aequalis Reversed Shoulder Prosthesis
Summary page 1
…Devices to Which Substantial Equivalence Is Claimed * Depuy Delta III Reverse Shoulder (#1(021478, #K050315, #K(062116) * Tornier Reverse Shoulder (#1(030941, #1(041873,41(050316) * Zimmer BF Reverse Shoulder (#K(052906, #K060704) * Zirmmer Anaitornica Reverse Shoulder…
Tornier2004—
*K041873Aequalis Reversed Shoulder Prosthesis
Summary page 1
…Which Substantial Equivalence Is Claimed * Depuy Delta III Reverse Shoulder (#1(021478, #K050315, #K(062116) * Tornier Reverse Shoulder (#1(030941, #1(041873,41(050316) * Zimmer BF Reverse Shoulder (#K(052906, #K060704) * Zirmmer Anaitornica Reverse Shoulder (#K(053274…
Tornier2004—
*K050316Aequalis Reversed Shoulder Prosthesis
Summary page 1
…stantial Equivalence Is Claimed * Depuy Delta III Reverse Shoulder (#1(021478, #K050315, #K(062116) * Tornier Reverse Shoulder (#1(030941, #1(041873,41(050316) * Zimmer BF Reverse Shoulder (#K(052906, #K060704) * Zirmmer Anaitornica Reverse Shoulder (#K(053274)…
Tornier2005—
*K052906Zimmer Trabecular Metal Reverse Shoulder System
Summary page 1
…elta III Reverse Shoulder (#1(021478, #K050315, #K(062116) * Tornier Reverse Shoulder (#1(030941, #1(041873,41(050316) * Zimmer BF Reverse Shoulder (#K(052906, #K060704) * Zirmmer Anaitornica Reverse Shoulder (#K(053274) * Encore Reverse Shoulder (#1(041066, #1(051075,…
Zimmer, Inc.200512
*K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM
Summary page 1
…Reverse Shoulder (#1(021478, #K050315, #K(062116) * Tornier Reverse Shoulder (#1(030941, #1(041873,41(050316) * Zimmer BF Reverse Shoulder (#K(052906, #K060704) * Zirmmer Anaitornica Reverse Shoulder (#K(053274) * Encore Reverse Shoulder (#1(041066, #1(051075, 1(052086)…
Zimmer, Inc.200610
*K053274Anatomical Shoulder Inverse/Reverse
Summary page 1
…Tornier Reverse Shoulder (#1(030941, #1(041873,41(050316) * Zimmer BF Reverse Shoulder (#K(052906, #K060704) * Zirmmer Anaitornica Reverse Shoulder (#K(053274) * Encore Reverse Shoulder (#1(041066, #1(051075, 1(052086) Device Description The Equinoxetm Reverse S…
Zimmer GmbH20063
*K041066Encore Reverse Shoulder Prosthesis
Summary page 1
…41(050316) * Zimmer BF Reverse Shoulder (#K(052906, #K060704) * Zirmmer Anaitornica Reverse Shoulder (#K(053274) * Encore Reverse Shoulder (#1(041066, #1(051075, 1(052086) Device Description The Equinoxetm Reverse Shoulder System includes a reverse semi-constrai…
Encore Medical L.P.20054
*K051075Encore Reverse Shoulder Prosthesis
Summary page 1
…* Zimmer BF Reverse Shoulder (#K(052906, #K060704) * Zirmmer Anaitornica Reverse Shoulder (#K(053274) * Encore Reverse Shoulder (#1(041066, #1(051075, 1(052086) Device Description The Equinoxetm Reverse Shoulder System includes a reverse semi-constrained prosthe…
Encore Medical L.P.20055
*K052086Encore Reverse Shoulder Prosthesis Humeral Stem Adapter
Summary page 1
…Zimmer BF Reverse Shoulder (#K(052906, #K060704) * Zirmmer Anaitornica Reverse Shoulder (#K(053274) * Encore Reverse Shoulder (#1(041066, #1(051075, 1(052086) Device Description The Equinoxetm Reverse Shoulder System includes a reverse semi-constrained prosthesis for…
Encore Medical, Inc.2005—

Also cleared against K021478: 18 other devices →

What descends from it? (190)

See all 190

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

NumberDeviceApplicantDecidedDescendants
K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.2008177
K080642Comprehensive Reverse Shoulder Class IBiomet, Inc.2008172
K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.201031
K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130
K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210
K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.20107
K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.20185
K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.20184
K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154
K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 15, 2025Class IIZ-2561-2025Process designReverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Mar 6, 2024Class IIZ-1422-2024Nonconforming 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-1418-2024Nonconforming 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-1425-2024Nonconforming 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-1423-2024Nonconforming 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-1424-2024Nonconforming 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-1419-2024Nonconforming 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.
Aug 24, 2020Class IIZ-3019-2020Labeling Change ControlExactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
Aug 24, 2020Class IIZ-3020-2020Labeling Change ControlExactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
Aug 21, 2018Class IIZ-0012-2019Under Investigation by firmThe Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.
Oct 25, 2016Class IIZ-0900-2017Component design/selectionDisengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
Jun 15, 2012Class IIZ-2117-2012Labeling 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…

The 5 latest of 13 recalls; the web page lists all.

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 9 months on median.
  • 12 of the 39 ancestors have a recall of any class.
  • Of its descendants, K073688 (Exactech, Inc., 2008) has gone furthest, with 177 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 Exactech EquinoxeTM Reverse Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The EquinoxeTM Reverse Shoulder is also indicated for failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

Indications for use as stated in the FDA summary.

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 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/K063569 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063569: Equinoxe Reverse 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/K063569

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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