510(k) Report

510(k) · Cleared

Cleared

Aequalis Ascend Modular Reverse Shoulder System

K112615510(k) SpecialCleared Oct 11, 201133-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

Tornier, Inc. · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Oct 11, 2011 as substantially equivalent to K110599 (Tornier, Inc., 2011) after a 33-day review. Its family tree reaches back 12 generations to 1991. 1 of the 193 devices in its family, counting itself, has a Class I recall. 97 later devices descend from it.

Decided
Oct 11, 2011
Review
33 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
1

Its longest line of descent runs back 12 generations to K911686 (1991). 95 ancestors in all, the oldest K790987 (1979). 97 later devices descend from it, 1 citing it directly. 1 of the 193 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2008: 4 other ancestors2007: 5 other ancestors2005: 6 other ancestors2009: 1 other ancestor2006: 9 other ancestors2004: 3 other ancestors2003: 6 other ancestors2001: 7 other ancestors2000: 6 other ancestors1999: 5 other ancestors1995: 2 other ancestors2002: 1 other ancestor1998: 3 other ancestors1997: 1 other ancestor1991: 2 other ancestors1987: 5 other ancestors1979: 1 other ancestor1996: 5 other ancestors1994: 1 other ancestor1993: 1 other ancestor1992: 2 other ancestors1988: 1 other ancestor1980: 2 other ancestors1989: 1 other ancestor1986: 1 other ancestor2013: 2 descendants cleared2015: 1 descendant cleared2026: 13 descendants cleared2023: 10 descendants cleared2022: 13 descendants cleared2019: 7 descendants cleared2014: 3 descendants cleared2017: 4 descendants cleared2025: 12 descendants cleared2021: 9 descendants cleared2018: 3 descendants cleared2016: 1 descendant cleared2020: 9 descendants cleared2024: 10 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 · recalled×2: 2 generations cleared close together, K073688 (2008), K080642 (2008) K110599 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 7 other ancestors3 generations back: 23 other ancestors4 generations back: 23 other ancestors5 generations back: 21 other ancestors6 generations back: 8 other ancestors7 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 16 descendants3 generations forward: 39 descendants4 generations forward: 27 descendants5 generations forward: 9 descendants6 generations forward: 2 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant K110599 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K080642 · Comprehensive Reverse Shoulder · Biomet, Inc. · 2008 · Class I recallK073688 · Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw · Exactech, Inc. · 2008 · recalledK063569 · 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. · 1991−10−50+5
  1. Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 8 generations between
  3. 3 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  4. 2 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  5. 1 generation backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  6. This deviceK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  7. Descendant · cites it directly · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  8. Descendant · 2 generations on · 29 of its ownK140082 Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014
  9. Descendant · 2 generations on · 26 of its ownK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
  10. Descendant · 2 generations on · 20 of its ownK163669 Humeris ShoulderFx Solutions · 2017
  11. Descendant · 2 generations on · 20 of its ownK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
Show all 12 generations
  1. Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 11 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 10 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 9 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 8 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 7 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 6 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 5 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 4 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 3 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 2 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 1 generation backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. This deviceK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011

Showing 5 of 97 descendants. See all descendants

Descendants cleared per year

2013: 22014: 32015: 12016: 12017: 42018: 32019: 72020: 92021: 92022: 132023: 102024: 102025: 122026: 13
2013high 13 (2022) · low 1 (2015)2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder2 generations back · 2008

Most influential descendants

Showing 5 of 97 · See all
  • K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · cites it directly96descendants
  • K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014 · 2 generations on29descendants
  • K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013 · 2 generations on26descendants
  • K163669Humeris ShoulderFx Solutions · 2017 · 2 generations on20descendants
  • K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2015 · 2 generations on20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−11K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−10K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−9K021478Delta ShoulderDepuy, Inc.2003—
−8K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−7K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−6K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−5K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−4K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−3K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−2K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−1K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
0 (this device)K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
+1K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
+2K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.2014—
+2K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2013—
+2K163669Humeris ShoulderFx Solutions2017—
+2K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198750
198810
198910
199120
199220
199310
199410
199520
199650
199710
199830
199950
200060
200170
200210
200360
200430
200560
200690
200750
200840
200910
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201430
201510
201610
201740
201830
201970
202090
202190
2022130
2023100
2024100
2025120
2026130
FIG. 1 — Lineage of K112615, 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? (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
*K110599Aequalis Ascend Modular Reverse Shoulder System
Summary page 5
…ation panel: Orthopedic Product code: KWT; KWS; HSD 5) ally Marketed Device to which Equivalence is Claimed: . Tornier Aequalis Ascend Modular Reverse Shoulder System: K110599 6) Device description The Aequalis Ascend Modular Reverse shoulder prosthesis is a component of semi- constrained reverse shoul…
Tornier, Inc.2011—

Also cleared against K110599: 1 other device →

What descends from it? (97)

See all 97

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201396

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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 9 months on median.
  • 24 of the 95 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K122698 (Tornier S.A.S., 2013) has gone furthest, with 96 descendants of its own.
  • 1 other device also cites its predicate K110599.

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. 2011, 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 Aequalis Ascend Modular Reverse Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: Rheumatoid arthritis Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) Correction of functional deformity Fractures of the humeral head Traumatic arthritis Revision of the devices if…

Read the full statement (199 words)

The Aequalis Ascend Modular Reverse Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

Rheumatoid arthritis

Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)

Correction of functional deformity

Fractures of the humeral head

Traumatic arthritis

Revision of the devices if sufficient bone stock remains

The Reverse Metaphysis and Assembly Screw or the Reverse Metaphysis, Reverse Spacer, and Reverse Spacer Assembly Screw are indicated for use as components of the Aequalis Ascend Modular Reverse total shoulder replacement and for transformation of the Aequalis Ascend Anatomic shoulder into a reverse shoulder prosthesis without the removal of the Diaphyseal stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if:

The Diaphyseal stem is well fixed

The patient has a functional deltoid muscle

The arthropathy is associated with a massive and non-repairable rotator cuff-tear.

All components are single use

The humeral stem is intended for cemented or cementless use

The glenoid implant is anchored to the bone with 4 screws and is for non-cemented 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 K110599

1 other device cites the same predicate.

  • K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc. · 2012

More from Tornier, Inc.

52 FDA decisions under this applicant name. See the company

  • K260721Tornier Perform Advanced GlenoidTornier, Inc. · 2026
  • K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc. · 2026
  • K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 20251 recall
  • K230352Tornier Humeral Nail and Tornier Long Humeral NailTornier, Inc. · 2023
  • K220914Tornier Perform Humeral System – FractureTornier, Inc. · 2022

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/K112615 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112615: Aequalis Ascend Modular 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/K112615

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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