510(k) Report

510(k) · Cleared

Cleared

Arrow Reverse Shoulder System

K112193510(k) TraditionalCleared Jul 12, 2012349-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

Fournitures Hospitalieres Industrie · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Jul 12, 2012 as substantially equivalent to K053274 (Zimmer GmbH, 2006) and 4 other predicates after a 349-day review. Its family tree reaches back 10 generations to 1991. 10 later devices descend from it.

Decided
Jul 12, 2012
Review
349 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
5

Its longest line of descent runs back 10 generations to K911686 (1991). 61 ancestors in all, the oldest K790987 (1979). 10 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2007: 1 other ancestor2006: 3 other ancestors2005: 5 other ancestors2004: 3 other ancestors2003: 2 other ancestors2000: 6 other ancestors2001: 5 other ancestors1999: 5 other ancestors1998: 3 other ancestors1996: 5 other ancestors1995: 2 other ancestors1992: 1 other ancestor1994: 1 other ancestor1987: 2 other ancestors1980: 2 other ancestors1979: 1 other ancestor1993: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor2015: 2 descendants cleared2023: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2025: 2 descendants cleared2024: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant 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 · recalledK073688 · Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw · Exactech, Inc. · 2008 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 10 other ancestors3 generations back: 22 other ancestors4 generations back: 7 other ancestors5 generations back: 9 other ancestors 1 generation forward: 8 descendants2 generations forward: 2 descendants K073688 · 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
  1. Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 6 generations between
  3. 3 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  4. 2 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  5. 1 generation backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  6. This deviceK112193 Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie · 2012
  7. Descendant · cites it directly · 5 of its ownK142778 ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie · 2015
  8. Descendant · cites it directly · 4 of its ownK162068 ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017
  9. Descendant · cites it directly · 4 of its ownK150568 ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie · 2015
  10. Descendant · cites it directly · 3 of its ownK171789 ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018
  11. Descendant · cites it directly · 2 of its ownK202024 ARROW Short Stem Humeral SystemFH Industrie · 2021
Show all 10 generations
  1. Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 9 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 8 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 7 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 6 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 5 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 4 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 3 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 2 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 1 generation backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. This deviceK112193 Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie · 2012

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2015: 22017: 12018: 12021: 12023: 12024: 12025: 22026: 1
2015high 2 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 10 · See all
  • K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie · 2015 · cites it directly5descendants
  • K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017 · cites it directly4descendants
  • K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie · 2015 · cites it directly4descendants
  • K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018 · cites it directly3descendants
  • K202024ARROW Short Stem Humeral SystemFH Industrie · 2021 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−9K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−8K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−7K021478Delta ShoulderDepuy, Inc.2003—
−6K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−5K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−4K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−3K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−2K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−1K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
0 (this device)K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie2012—
+1K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie2015—
+1K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie2017—
+1K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie2015—
+1K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie2018—
+1K202024ARROW Short Stem Humeral SystemFH Industrie2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198720
198910
199210
199310
199410
199520
199650
199830
199950
200060
200150
200320
200430
200550
200630
200710
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201710
201810
202110
202310
202410
202520
202610
FIG. 1 — Lineage of K112193, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (5)

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
*K053274Anatomical Shoulder Inverse/Reverse
Summary page 5
…Information on devices to which substantial equivalence is claimed: Manufacturer: Zimmer . Device Trade Name: Anatomical Shoulder® Inverse/Reverse . system 510 (K): K053274 Manufacturer: Exactech, Inc. - Device Trade Name: Equinoxe™ Reverse Shoulder system 510 (K): K073688/K063569 Manufacturer: De…
Zimmer GmbH20063
*K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw
Summary page 5
…ade Name: Anatomical Shoulder® Inverse/Reverse . system 510 (K): K053274 Manufacturer: Exactech, Inc. - Device Trade Name: Equinoxe™ Reverse Shoulder system 510 (K): K073688/K063569 Manufacturer: Depuy Device Trade Name: Delta Xtend™ Reverse Shoulder system. 510 (K): K062250 Manufacturer: Fournitur…
Exactech, Inc.20081
*K063569Equinoxe Reverse Shoulder System
Summary page 5
…: Anatomical Shoulder® Inverse/Reverse . system 510 (K): K053274 Manufacturer: Exactech, Inc. - Device Trade Name: Equinoxe™ Reverse Shoulder system 510 (K): K073688/K063569 Manufacturer: Depuy Device Trade Name: Delta Xtend™ Reverse Shoulder system. 510 (K): K062250 Manufacturer: Fournitures Hospi…
Exactech, Inc.200713
*K062250Delta Xtend Reverse Shoulder System
Summary page 5
…Device Trade Name: Equinoxe™ Reverse Shoulder system 510 (K): K073688/K063569 Manufacturer: Depuy Device Trade Name: Delta Xtend™ Reverse Shoulder system. 510 (K): K062250 Manufacturer: Fournitures Hospitaliéres Industrie ARROW?® Anatomical shoulder system K093599 S-5. Device Description: The ARR…
DePuy Orthopaedics, Inc.20078
*K093599Arrow Anatomical Shoulder System
Summary page 5
…Depuy Device Trade Name: Delta Xtend™ Reverse Shoulder system. 510 (K): K062250 Manufacturer: Fournitures Hospitaliéres Industrie ARROW?® Anatomical shoulder system K093599 S-5. Device Description: The ARROW® reverse shoulder system is a shoulder joint prosthesis, composed of the following elements…
Fournitures Hospitalieres Industrie2010—

Also cleared against K053274: 12 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155
K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174
K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154
K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183
K202024ARROW Short Stem Humeral SystemFH Industrie20212
K253345JARVIS Diaphyseal Stem StandardFH Industrie20251
K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241
K232226ARROW Off-Centred Humeral InsertFH Industrie20230

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 21 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
  • 17 of the 61 ancestors have a recall of any class.
  • Of its descendants, K142778 (Fournitures Hospitalieres Industrie, 2015) has gone furthest, with 5 descendants of its own.
  • 12 other devices also cite its predicate K053274.

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. 2012, 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 ARROW® reverse shoulder prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented of cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for 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 K053274

12 other devices cite the same predicate.

  • K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH · 2017
  • K150488Humelock II Reversible Shoulder SystemFx Solutions · 2015
  • K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
  • K142139SMR 40MM GlenosphereLima Corporate S.P.A. · 2014
  • K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
  • K120374Seviin Reverse ShoulderIngen Orthopedics, LLC · 2012

More from Fournitures Hospitalieres Industrie

24 FDA decisions under this applicant name. See the company

  • K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018
  • K163148BePOD® Foot ScrewsFournitures Hospitalieres Industrie · 2017
  • K163710BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie · 2017
  • K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017
  • K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie · 2017

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/K112193 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112193: Arrow 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/K112193

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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