510(k) Report

510(k) · Cleared

Cleared

Aequalis Reversed Shoulder Prosthesis

K030941510(k) TraditionalCleared May 14, 2004416-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 · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on May 14, 2004 as substantially equivalent to K991585 (Biomet, Inc., 1999) and 2 other predicates after a 416-day review. Its family tree reaches back 4 generations to 1991. 1 of the 292 devices in its family, counting itself, has a Class I recall. 280 later devices descend from it.

Decided
May 14, 2004
Review
416 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K911686 (1991). 11 ancestors in all, the oldest K800494 (1980). 280 later devices descend from it, 17 citing it directly. 1 of the 292 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1999: 2 other ancestors1995: 1 other ancestor1980: 2 other ancestors1998: 1 other ancestor1992: 1 other ancestor2011: 10 descendants cleared2019: 17 descendants cleared2015: 7 descendants cleared2013: 15 descendants cleared2005: 2 descendants cleared2006: 4 descendants cleared2007: 3 descendants cleared2008: 6 descendants cleared, 1 with a Class I recall12017: 16 descendants cleared2004: 1 descendant cleared2014: 13 descendants cleared2012: 14 descendants cleared2010: 6 descendants cleared2016: 10 descendants cleared2026: 24 descendants cleared2018: 19 descendants cleared2024: 17 descendants cleared2020: 20 descendants cleared2023: 16 descendants cleared2021: 25 descendants cleared2025: 16 descendants cleared2022: 19 descendants clearedK911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K021478 · Delta Shoulder · Depuy, Inc. · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 17 descendants2 generations forward: 53 descendants, 1 with a Class I recall13 generations forward: 93 descendants4 generations forward: 64 descendants5 generations forward: 35 descendants6 generations forward: 15 descendants7 generations forward: 3 descendants K021478 · 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. · 19910+5
  1. Root · 4 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 3 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 2 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 1 generation backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. This deviceK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. Descendant · cites it directly · 277 of its ownK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. Descendant · cites it directly · 248 of its ownK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
  8. Descendant · 2 generations on · 239 of its ownK053274 Anatomical Shoulder Inverse/ReverseZimmer GmbH · 2006 · Recalled
  9. Descendant · 2 generations on · 216 of its ownK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  10. Descendant · 3 generations on · 207 of its ownK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled

Showing 5 of 280 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 42007: 32008: 62010: 62011: 102012: 142013: 152014: 132015: 72016: 102017: 162018: 192019: 172020: 202021: 252022: 192023: 162024: 172025: 162026: 24
2004high 25 (2021) · low 0 (2009)2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder2 generations on · 2008

Most influential descendants

Showing 5 of 280 · See all
  • K041873Aequalis Reversed Shoulder ProsthesisTornier · 2004 · cites it directly277descendants
  • K050316Aequalis Reversed Shoulder ProsthesisTornier · 2005 · cites it directly248descendants
  • K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH · 2006 · 2 generations on239descendants
  • K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · 2 generations on216descendants
  • K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · 3 generations on207descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−3K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−2K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−1K021478Delta ShoulderDepuy, Inc.2003—
0 (this device)K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
+1K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
+1K050316Aequalis Reversed Shoulder ProsthesisTornier2005—
+2K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH20063
+2K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
+3K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198020
199210
199510
199810
199920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200640
200730
200861
201060
2011100
2012140
2013150
2014130
201570
2016100
2017160
2018190
2019170
2020200
2021250
2022190
2023160
2024170
2025160
2026240
FIG. 1 — Lineage of K030941, 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? (3)

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
*K991585Bipolar Shoulder Prosthesis
Summary page 1
…Tel: 801 233-0075 Fax: 801 233-0089 e-mail: grabarz(ii ntregcon.con1 4.0 Equivalent / Predicate device: BIPOLAR SHOULDER PROSTHESIS, Biomet (K991585), Delta 3 Reversed Shoulder Prosthesis, DePuy (K021478) AEQUALIS Shoulder System, Tornier (K952928)…
Biomet, Inc.1999—
*K021478Delta Shoulder
Cleared while this submission was under review
Summary page 1
…4.0 Equivalent / Predicate device: BIPOLAR SHOULDER PROSTHESIS, Biomet (K991585), Delta 3 Reversed Shoulder Prosthesis, DePuy (K021478) AEQUALIS Shoulder System, Tornier (K952928) liii 1 l'l;tii1 iii;tu IK I 1:iII I. ( . ' I…
Depuy, Inc.2003—
*K952928Aequalis Shoulder System for Total & Hemishoulder Applications
Summary page 1
…BIPOLAR SHOULDER PROSTHESIS, Biomet (K991585), Delta 3 Reversed Shoulder Prosthesis, DePuy (K021478) AEQUALIS Shoulder System, Tornier (K952928) liii 1 l'l;tii1 iii;tu IK I 1:iII I. ( . ' I ji,L II' l…
Tornier1995—

Also cleared against K991585: 6 other devices →

What descends from it? (280)

See all 280

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

NumberDeviceApplicantDecidedDescendants
K041873Aequalis Reversed Shoulder ProsthesisTornier2004277
K050316Aequalis Reversed Shoulder ProsthesisTornier2005248
K061439Aequalis Reversed ProsthesisTornier2006199
K063569Equinoxe Reverse Shoulder SystemExactech, Inc.2007190
K081059Aequalis Reversed Shoulder ProsthesisTornier2008179
K071948Aequalis Reversed AdapterTornier2007178
K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175
K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164
K100142Aequalis Reversed Shoulder ProsthesisTornier2010147
K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133

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 on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • Of its descendants, K041873 (Tornier, 2004) has gone furthest, with 277 descendants of its own.
  • 6 other devices also cite its predicate K991585.

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.

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 Reversed Shoulder Prosthesis is indicated for patients, with a functional deltoid muscle, as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear.

The Aequalis Reversed Shoulder Prosthesis humeral component is intended for cemented use only and the glenoid component is intended for non cemented use with 4 screws for fixation.

Indications for use as stated in the FDA summary.

Also cleared against K991585

6 other devices cite the same predicate.

  • K050316Aequalis Reversed Shoulder ProsthesisTornier · 2005
  • K041873Aequalis Reversed Shoulder ProsthesisTornier · 2004
  • K021478Delta ShoulderDepuy, Inc. · 2003
  • K010827Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 20011 recall
  • K010657Copeland MB Resurfacing Humeral HeadsBiomet Manufacturing, Inc. · 2001
  • K002998Biomet BI-Polar Shoulder SystemBiomet, Inc. · 20001 recall

More from Tornier

44 FDA decisions under this applicant name. See the company

  • K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture…Tornier · 2012
  • K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier · 2012
  • K111902Aequalis Shoulder SystemTornier · 2011
  • K094013HLS Kneetec SystemTornier · 2011
  • K100142Aequalis Reversed Shoulder ProsthesisTornier · 2010

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/K030941 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030941: Aequalis Reversed Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030941

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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