510(k) Report

510(k) · Cleared

Cleared

Arthrex Univers Revers Modular Glenoid System

K191960510(k) SpecialCleared Dec 23, 2019153-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

Arthrex, Inc. · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Dec 23, 2019 as substantially equivalent to K173900 (Arthrex, Inc., 2018) after a 153-day review. Its family tree reaches back 14 generations to 1991.

Decided
Dec 23, 2019
Review
153 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
1

Its longest line of descent runs back 14 generations to K911686 (1991). 45 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 3 other ancestors2005: 1 other ancestor2003: 2 other ancestors2009: 1 other ancestor2008: 2 other ancestors2007: 2 other ancestors2001: 3 other ancestors1999: 3 other ancestors1995: 1 other ancestor2004: 2 other ancestors2000: 4 other ancestors1998: 1 other ancestor1980: 2 other ancestors1996: 1 other ancestor1992: 1 other ancestor1987: 1 other ancestor1993: 1 other ancestorReference device: K142863 · Univers Rivers Shoulder Prosthesis System · Arthrex, Inc. · 2014Reference device: K161782 · Arthrex Univers Revers Shoulder Prosthesis System · Arthrex, Inc. · 2016Reference device: K171841 · Arthrex Shoulder System · Arthrex, Inc. · 2018K911686 · 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. · 2003×2: 2 generations cleared close together, K030941 (2004), K041873 (2004) K050316 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2005K061439 · Aequalis Reversed Prosthesis · Tornier · 2006K071948 · Aequalis Reversed Adapter · Tornier · 2007K082120 · Aequalis Reversed Fracture Shoulder Prothesis · Tornier · 2008K100142 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2010K130129 · Univers Revers Shoulder Prosthesis System · Arthrex, Inc. · 2013K142863 · Univers Rivers Shoulder Prosthesis System · Arthrex, Inc. · 2014K173900 · Arthrex Univers Revers Modular Glenoid System · Arthrex, Inc. · 201819801990200020102020
Other ancestors, by generation 3 generations back: 1 other ancestor4 generations back: 2 other ancestors5 generations back: 10 other ancestors6 generations back: 13 other ancestors7 generations back: 4 other ancestors8 generations back: 1 other ancestor K173900 · Arthrex Univers Revers Modular Glenoid System · Arthrex, Inc. · 2018K142863 · Univers Rivers Shoulder Prosthesis System · Arthrex, Inc. · 2014K130129 · Univers Revers Shoulder Prosthesis System · Arthrex, Inc. · 2013K100142 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2010K082120 · Aequalis Reversed Fracture Shoulder Prothesis · Tornier · 2008K071948 · Aequalis Reversed Adapter · Tornier · 2007K061439 · Aequalis Reversed Prosthesis · Tornier · 2006K050316 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2005K041873 · 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
  1. Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 10 generations between
  3. 3 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
  4. 2 generations backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
  5. 1 generation backK173900 Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. · 2018
  6. This deviceK191960 Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. · 2019
Show all 14 generations
  1. Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 8 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
  8. 7 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
  9. 6 generations backK071948 Aequalis Reversed AdapterTornier · 2007
  10. 5 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
  11. 4 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
  12. 3 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
  13. 2 generations backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
  14. 1 generation backK173900 Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. · 2018
  15. This deviceK191960 Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−13K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−12K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−11K021478Delta ShoulderDepuy, Inc.2003—
−10K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−9K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−8K050316Aequalis Reversed Shoulder ProsthesisTornier2005—
−7K061439Aequalis Reversed ProsthesisTornier2006—
−6K071948Aequalis Reversed AdapterTornier2007—
−5K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008—
−4K100142Aequalis Reversed Shoulder ProsthesisTornier2010—
−3K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.2013—
−2K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.2014—
−1K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.2018—
0 (this device)K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198020
198710
199210
199310
199510
199610
199810
199930
200040
200130
200320
200420
200510
200630
200720
200820
200910
FIG. 1 — Lineage of K191960, 1991–2019Source: 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
*K173900Arthrex Univers Revers Modular Glenoid System
Summary page 4
…ssification Name 21 CFR 888.3660: Prosthesis, Shoulder, semi-constrained metal/polymer, cemented Regulatory Class II Predicate Device K173900: Arthrex Univers Revers Modular Glenoid System Reference Device K142863: Univers Revers Shoulder Prosthesis System…
Arthrex, Inc.2018—
†K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.2014—
†K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.2016—
†K171841Arthrex Shoulder SystemArthrex, Inc.2018—

Also cleared against K173900: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
  • 6 of the 45 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K173900.

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. 2019, 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 Arthrex Univers Revers Modular Glenoid System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The Arthrex Univers Revers Modular Glenoid System is indicated…

Read the full statement (113 words)

The Arthrex Univers Revers Modular Glenoid System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The Arthrex Univers Revers Modular Glenoid System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The Arthrex Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.

Indications for use as stated in the FDA summary.

Also cleared against K173900

4 other devices cite the same predicate.

  • K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc. · 2026
  • K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc. · 2021
  • K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
  • K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc. · 2020

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026

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/K191960 · printed Nov 4, 2026

Cite this page

510(k) Report. “K191960: Arthrex Univers Revers Modular Glenoid System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K191960

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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