510(k) Report

510(k) · Cleared

Cleared

ARROW Off-Centred Humeral Insert

K232226510(k) SpecialCleared Aug 29, 202333-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

FH Industrie · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Aug 29, 2023 as substantially equivalent to K112193 (Fournitures Hospitalieres Industrie, 2012) and 4 other predicates after a 33-day review. Its family tree reaches back 16 generations to 1991. 1 of the 119 devices in its family, counting itself, has a Class I recall.

Decided
Aug 29, 2023
Review
33 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
5

Its longest line of descent runs back 16 generations to K911686 (1991). 118 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 119 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2015: 2 other ancestors2012: 4 other ancestors2017: 1 other ancestor2010: 2 other ancestors2009: 2 other ancestors2008: 4 other ancestors2007: 5 other ancestors2006: 10 other ancestors2005: 6 other ancestors2004: 5 other ancestors2011: 2 other ancestors2003: 6 other ancestors2001: 9 other ancestors2000: 8 other ancestors1999: 6 other ancestors1998: 3 other ancestors1996: 6 other ancestors1995: 2 other ancestors1994: 1 other ancestor1992: 2 other ancestors1987: 5 other ancestors1980: 2 other ancestors1979: 1 other ancestor2002: 1 other ancestor1997: 1 other ancestor1993: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor1991: 2 other ancestors1988: 1 other ancestorReference device: K093599 · Arrow Anatomical Shoulder System · Fournitures Hospitalieres Industrie · 2010K911686 · 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) ×2: 2 generations cleared close together, K110599 (2011), K112615 (2011) K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalledK132285 · Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2013K171789 · ARROW Reverse Porous Glenoid · Fournitures Hospitalieres Industrie · 201819801990200020102020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 15 other ancestors3 generations back: 32 other ancestors4 generations back: 22 other ancestors5 generations back: 16 other ancestors6 generations back: 10 other ancestors7 generations back: 2 other ancestors8 generations back: 2 other ancestors9 generations back: 1 other ancestor K171789 · ARROW Reverse Porous Glenoid · Fournitures Hospitalieres Industrie · 2018K132285 · Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2013K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalledK112615 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K110599 · 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. · 1991−15−10−50
  1. Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 12 generations between
  3. 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  4. 2 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
  5. 1 generation backK171789 ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018
  6. This deviceK232226 ARROW Off-Centred Humeral InsertFH Industrie · 2023
Show all 16 generations
  1. Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 15 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 14 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 13 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 12 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 11 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 10 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 9 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 8 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 7 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 6 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 5 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. 4 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  14. 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  15. 2 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
  16. 1 generation backK171789 ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018
  17. This deviceK232226 ARROW Off-Centred Humeral InsertFH Industrie · 2023

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder4 generations back · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−15K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−14K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−13K021478Delta ShoulderDepuy, Inc.2003—
−12K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−11K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−10K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−9K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−8K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−7K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−6K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−5K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−3K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
−2K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2013—
−1K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie2018—
0 (this device)K232226ARROW Off-Centred Humeral InsertFH Industrie2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198750
198810
198910
199120
199220
199310
199410
199520
199660
199710
199830
199960
200080
200190
200210
200360
200450
200560
2006100
200750
200840
200920
201020
201120
201240
201520
201710
FIG. 1 — Lineage of K232226, 1991–2023Source: 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.

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? (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
*K112193Arrow Reverse Shoulder System
Summary page 4
…PHX Device Description: The ARROW Off-Centered Humeral Insert is used for reverse shoulder prosthesis, with implants of Arrow Reverse Shoulder System (K112193 and K150568), similar to the standard version. This is a modification of the standard ARROW reverse prosthesis (K112193), with th…
Fournitures Hospitalieres Industrie2012—
*K150568ARROW Humeral stems size 6 and 16
Summary page 4
…PHX Device Description: The ARROW Off-Centered Humeral Insert is used for reverse shoulder prosthesis, with implants of Arrow Reverse Shoulder System (K112193 and K150568), similar to the standard version. This is a modification of the standard ARROW reverse prosthesis (K112193), with the purpose of…
Fournitures Hospitalieres Industrie2015—
*K122698Aequalis Ascend Flex Shoulder System
Summary page 5
…Primary Predicate: • FH Industrie: Arrow Reverse Shoulder System – K112193 and K150568 Secondary Predicates: • Tornier Aequalis ASCEND FLEX Shoulder System– K122698 • FH Industrie: Arrow reverse Porous Glenoid: K171789 • Tornier Aequalis Reversed Shoulder System – K132285 Instrument…
Tornier S.A.S.20132
*K171789ARROW Reverse Porous Glenoid
Summary page 5
…ulder System – K112193 and K150568 Secondary Predicates: • Tornier Aequalis ASCEND FLEX Shoulder System– K122698 • FH Industrie: Arrow reverse Porous Glenoid: K171789 • Tornier Aequalis Reversed Shoulder System – K132285 Instrument Biocompatibility Reference Device: ARROW Anatomical Should…
Fournitures Hospitalieres Industrie2018—
*K132285Aequalis Reversed Shoulder Prosthesis
Summary page 5
…Tornier Aequalis ASCEND FLEX Shoulder System– K122698 • FH Industrie: Arrow reverse Porous Glenoid: K171789 • Tornier Aequalis Reversed Shoulder System – K132285 Instrument Biocompatibility Reference Device: ARROW Anatomical Shoulder System – K093599 The Indications for Use, Materials, an…
Tornier S.A.S.2013—
†K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie2010—

Also cleared against K112193: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

What does this lineage say?

  • The line of descent spans 32 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
  • 27 of the 118 ancestors have a recall of any class; 1 has a Class I recall.
  • 7 other devices also cite its predicate K112193.

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. 2023, 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 Off-Centred Humeral Insert is designed for the following indications:

REVERSE PROSTHESIS (POROUS GLENOID IMPLANT)

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 or cementless application while the porous 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 K112193

7 other devices cite the same predicate.

  • K253345JARVIS Diaphyseal Stem StandardFH Industrie · 2025
  • K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2024
  • K202024ARROW Short Stem Humeral SystemFH Industrie · 2021
  • K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018
  • K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017
  • K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie · 2015

More from FH Industrie

9 FDA decisions under this applicant name. See the company

  • K254003JARVIS Metaphyseal StemFH Industrie · 2026
  • K253345JARVIS Diaphyseal Stem StandardFH Industrie · 2025
  • K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2025
  • K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2024
  • K220758e-Ortho Shoulder Software v1.1FH Industrie · 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/K232226 · printed Nov 6, 2026

Cite this page

510(k) Report. “K232226: ARROW Off-Centred Humeral Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232226

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