510(k) · Cleared

Cleared

ARROW Short Stem Humeral System

K202024510(k) TraditionalCleared Nov 30, 2021496-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 Nov 30, 2021 as substantially equivalent to K112193 (Fournitures Hospitalieres Industrie, 2012) and 7 other predicates after a 496-day review. Its family tree reaches back 17 generations to 1991. 1 of the 166 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided: Nov 30, 2021
Review: 496 days
Class: Class II
Product code: PHX
Recalls: None
Predicates: 8

Its longest line of descent runs back 17 generations to K911686 (1991). 163 ancestors in all, the oldest K790987 (1979). 2 later devices descend from it, 2 citing it directly. 1 of the 166 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 17 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
13 generations between
3 generations backK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
2 generations backK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
1 generation backK190290 AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019
This deviceK202024 ARROW Short Stem Humeral SystemFH Industrie · 2021
Descendant · cites it directly · 1 of its ownK253345 JARVIS Diaphyseal Stem StandardFH Industrie · 2025
Descendant · cites it directly · 0 of its ownK254003 JARVIS Metaphyseal StemFH Industrie · 2026

Show all 17 generations

Root · 17 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
16 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
15 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
14 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
13 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
12 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
11 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
10 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
9 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
8 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
7 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
6 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
5 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
4 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
3 generations backK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
2 generations backK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
1 generation backK190290 AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019
This deviceK202024 ARROW Short Stem Humeral SystemFH Industrie · 2021

Class I recalls in this family

K080642 Comprehensive Reverse Shoulderdirect predicate · 2008

Most influential descendants

Showing 2 of 2 · See all

K253345JARVIS Diaphyseal Stem StandardFH Industrie · 2025 · cites it directly1descendant
K254003JARVIS Metaphyseal StemFH Industrie · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−17	K911686	Global Total Shoulder, Uncement Humeral Hemi-Shoul	Depuy, Inc.	1991	—
−16	K984541	Global FX Humeral Stem, Global Advantage Humeral Head	DePuy Orthopaedics, Inc.	1999	—
−15	K992065	Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…	DePuy Orthopaedics, Inc.	1999	—
−14	K021478	Delta Shoulder	Depuy, Inc.	2003	—
−13	K030941	Aequalis Reversed Shoulder Prosthesis	Tornier	2004	—
−12	K041873	Aequalis Reversed Shoulder Prosthesis	Tornier	2004	—
−11	K052906	Zimmer Trabecular Metal Reverse Shoulder System	Zimmer, Inc.	2005	12
−10	K060704	Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM	Zimmer, Inc.	2006	10
−9	K063569	Equinoxe Reverse Shoulder System	Exactech, Inc.	2007	13
−8	K073688	Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw	Exactech, Inc.	2008	1
−7	K080642	Comprehensive Reverse Shoulder	Biomet, Inc.	2008	Class I
−6	K110599	Aequalis Ascend Modular Reverse Shoulder System	Tornier, Inc.	2011	—
−5	K112615	Aequalis Ascend Modular Reverse Shoulder System	Tornier, Inc.	2011	—
−4	K122698	Aequalis Ascend Flex Shoulder System	Tornier S.A.S.	2013	2
−3	K141990	Encore Humeral Shoulder Stem	Encore Medical L.P.	2014	3
−2	K172351	AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate…	Encore Medical L.P.	2017	3
−1	K190290	AltiVate Reverse Humeral Stem, 48mm	Encore Medical L.P.	2019	—
0 (this device)	K202024	ARROW Short Stem Humeral System	FH Industrie	2021	—
+1	K253345	JARVIS Diaphyseal Stem Standard	FH Industrie	2025	—
+1	K254003	JARVIS Metaphyseal Stem	FH Industrie	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1980	2	0
1981	1	0
1986	1	0
1987	5	0
1988	1	0
1989	1	0
1991	2	0
1992	5	0
1993	3	0
1994	3	0
1995	8	0
1996	6	0
1997	3	0
1998	7	0
1999	6	0
2000	9	0
2001	9	0
2002	3	0
2003	8	0
2004	6	0
2005	8	0
2006	10	0
2007	7	0
2008	7	0
2009	2	0
2010	4	0
2011	5	0
2012	5	0
2013	3	0
2014	2	0
2015	1	0
2016	1	0
2017	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0
2026	1	0

FIG. 1 — Lineage of K202024, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (8)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K112193	Arrow Reverse Shoulder System Summary page 6 …to indications for use, design, dimension, and materials to the following devices, previously cleared by the FDA: Primary Predicate: FH Industrie, Arrow Humeral Stem - K112193 Additional Predicates: • FH Industrie, Arrow Humeral Stem - K093599, K150569 • Exactech, Equinoxe Preserve Stem – K1…	Fournitures Hospitalieres Industrie	2012	—
*	K093599	Arrow Anatomical Shoulder System Summary page 6 …devices, previously cleared by the FDA: Primary Predicate: FH Industrie, Arrow Humeral Stem - K112193 Additional Predicates: • FH Industrie, Arrow Humeral Stem - K093599, K150569 • Exactech, Equinoxe Preserve Stem – K162726 • DJO, Altivate Preserve – K190290 • Biomet, Comprehensiv…	Fournitures Hospitalieres Industrie	2010	—
*	K150568	ARROW Humeral stems size 6 and 16 Our reading of the summary gave K150569, FDA’s number for LaparoVue (Buffalo Filter, LLC). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “FH Industrie, Arrow Humeral Stem”.	Fournitures Hospitalieres Industrie	2015	—
*	K162726	Exactech® Equinoxe® Preserve Stem Summary page 6 …FH Industrie, Arrow Humeral Stem - K112193 Additional Predicates: • FH Industrie, Arrow Humeral Stem - K093599, K150569 • Exactech, Equinoxe Preserve Stem – K162726 • DJO, Altivate Preserve – K190290 • Biomet, Comprehensive Micro – K060692, K080642 • Depuy Delta III – K021478…	Exactech, Inc.	2017	1
*	K190290	AltiVate Reverse Humeral Stem, 48mm Summary page 6 …3 Additional Predicates: • FH Industrie, Arrow Humeral Stem - K093599, K150569 • Exactech, Equinoxe Preserve Stem – K162726 • DJO, Altivate Preserve – K190290 • Biomet, Comprehensive Micro – K060692, K080642 • Depuy Delta III – K021478 Reference devices /Biocompatiblity Pred…	Encore Medical L.P.	2019	—
*	K060692	Comprehensive Primary Shoulder Stems Summary page 6 …, Arrow Humeral Stem - K093599, K150569 • Exactech, Equinoxe Preserve Stem – K162726 • DJO, Altivate Preserve – K190290 • Biomet, Comprehensive Micro – K060692, K080642 • Depuy Delta III – K021478 Reference devices /Biocompatiblity Predicates: Fournitures Hospitalieres Industrie: A…	Biomet Manufacturing Corp	2006	6
*	K080642	Comprehensive Reverse Shoulder Summary page 6 …umeral Stem - K093599, K150569 • Exactech, Equinoxe Preserve Stem – K162726 • DJO, Altivate Preserve – K190290 • Biomet, Comprehensive Micro – K060692, K080642 • Depuy Delta III – K021478 Reference devices /Biocompatiblity Predicates: Fournitures Hospitalieres Industrie: ARROW Glen…	Biomet, Inc.	2008	Class I
*	K021478	Delta Shoulder Summary page 6 …• Exactech, Equinoxe Preserve Stem – K162726 • DJO, Altivate Preserve – K190290 • Biomet, Comprehensive Micro – K060692, K080642 • Depuy Delta III – K021478 Reference devices /Biocompatiblity Predicates: Fournitures Hospitalieres Industrie: ARROW Glenoid base porous (K162068, K171789)…	Depuy, Inc.	2003	—
†	K162068	ARROW Anatomical Porous glenoid	Fournitures Hospitalieres Industrie	2017	—
†	K171789	ARROW Reverse Porous Glenoid	Fournitures Hospitalieres Industrie	2018	—

Also cleared against K112193: 7 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K253345	JARVIS Diaphyseal Stem Standard	FH Industrie	2025	1
K254003	JARVIS Metaphyseal Stem	FH Industrie	2026	0

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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 30 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
46 of the 163 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K253345 (FH Industrie, 2025) has gone furthest, with 1 descendant of its own.
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. 2021, this device’s year, is highlighted.

FDA decisions per year · PHX

9in 2025

2007high 21 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PHX

72in 2025

2007high 206 (2015) · low 72 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PHX

3in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	5	97	0	0
2008	6	79	0	0
2009	1	—	0	0
2010	8	124	0	0
2011	12	94	0	0
2012	12	114	0	0
2013	8	143	0	0
2014	12	110	0	0
2015	4	206	2	14
2016	4	132	0	5
2017	11	141	0	25
2018	14	127	1	323
2019	9	144	3	504
2020	13	143	3	986
2021	21	143	8	1,404
2022	9	198	0	1,342
2023	9	154	7	1,401
2024	9	139	1	2,142
2025	9	72	3	2,848
2026	18	130	7	—

What is it indicated for?

The prostheses from FH Industrie are designed for specific indications such as: SIMPLE HUMERAL PROSTHESIS - Humeral head necrosis without injury to the glenoid cavity. - Extensive humeral head cartilage damage without injury to the glenoid cavity - Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant. - Rheumatoid polyarthritis with thin rotator cuff. - Off-centred osteoarthritis with irreparable cuff, and with…

Read the full statement (263 words)

The prostheses from FH Industrie are designed for specific indications such as:

SIMPLE HUMERAL PROSTHESIS

- Humeral head necrosis without injury to the glenoid cavity.

- Extensive humeral head cartilage damage without injury to the glenoid cavity

- Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.

- Rheumatoid polyarthritis with thin rotator cuff.

- Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.

TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH 4 PEGS)

- Centred glenohumeral osteoarthritis with functional rotator cuff

- Rheumatoid polyarthritis with functional rotator cuff

- Post-traumatic sequela, functional rotator cuff with glenoid injury.

TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)

- Centred glenohumeral osteoarthritis

- Rheumatoid polyarthritis

- Post-traumatic sequela with glenoid injury

- Revision for glenoid loosening

- Glenoid bone loss, where bone graft is needed

A functional rotator cuff is necessary to use this device

REVERSE PROSTHESIS (METAL-BACK OR 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.

For all types of prosthesis, the glenoid baseplate (metal-back or porous) is intended for cementless use with the addition of bone screws for fixation, the humeral short stem (metaphyseal stem and diaphyseal stem) is intended for cementless use.

At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K202024 · printed Nov 6, 2026

Cite this page

510(k) Report. “K202024: ARROW Short Stem Humeral System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202024

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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