510(k) Report

FDA product code · Orthopedic

Shoulder Prosthesis, Reverse Configuration

PHXClass II21 CFR 888.3660510(k) required207 decisions since 200335 recalls

207 FDA decisions since 2003. 510(k) reviews decided 2021–2025 took a median of 153 days (half between 59 and 205). 35 recalls name this code, 0 of them Class I. The most-cited predicate is K041066, named by 25 later devices.

Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, orthopedic panel

Twenty years of PHX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — PHX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PHX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PHX devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K041066Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 200525cite it
  • K080642Comprehensive Reverse ShoulderBiomet, Inc. · 200824cite it
  • K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. · 201621cite it
  • K021478Delta ShoulderDepuy, Inc. · 200319cite it
  • K051075Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 200519cite it
  • K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 200717cite it

Which PHX devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A. · 202620generations
  • K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA…Encore Medical L.P. · 202520generations
  • K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 202420generations
  • K254003JARVIS Metaphyseal StemFH Industrie · 202619generations
  • K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 202519generations
  • K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 202319generations

What has FDA decided in PHX lately?

  • 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
  • K261016MSS - Humeral reverse liners extensionMedacta International, SA · 2026

All 207 PHX decisions →

What has been recalled in PHX lately?

  • K243643Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard…restor3d Inc. · Jun 30, 2026Class II
  • K241043Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide…Zimmer, Inc. · May 20, 2026Class II
  • K241043Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number…Zimmer, Inc. · May 20, 2026Class II
  • K241043Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number…Zimmer, Inc. · May 20, 2026Class II
  • K241043Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide…Zimmer, Inc. · May 20, 2026Class II
  • K241043Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide…Zimmer, Inc. · May 20, 2026Class II

Related product codes

Other codes under 21 CFR 888.3660.

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