510(k) · Cleared
ClearedJARVIS Metaphyseal Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FH Industrie · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Jan 9, 2026 as substantially equivalent to K202024 (FH Industrie, 2021) and 1 other predicate after a 25-day review. Its family tree reaches back 19 generations to 1991. 1 of the 166 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 9, 2026
- Review
- 25 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K911686 (1991). 165 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 166 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 15 generations between
- 3 generations backK190290 AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019
- 2 generations backK202024 ARROW Short Stem Humeral SystemFH Industrie · 2021
- 1 generation backK253345 JARVIS Diaphyseal Stem StandardFH Industrie · 2025
- This deviceK254003 JARVIS Metaphyseal StemFH Industrie · 2026
Show all 19 generations
- Root · 19 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 18 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 17 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 16 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 15 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 14 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 13 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 12 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 11 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 10 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 9 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 8 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 7 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 6 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 5 generations backK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
- 4 generations backK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
- 3 generations backK190290 AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019
- 2 generations backK202024 ARROW Short Stem Humeral SystemFH Industrie · 2021
- 1 generation backK253345 JARVIS Diaphyseal Stem StandardFH Industrie · 2025
- This deviceK254003 JARVIS Metaphyseal StemFH Industrie · 2026
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −18 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −17 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −16 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −15 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −14 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −13 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −12 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −11 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −10 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −9 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −8 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −7 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −6 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −5 | K141990 | Encore Humeral Shoulder Stem | Encore Medical L.P. | 2014 | 3 |
| −4 | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate… | Encore Medical L.P. | 2017 | 3 |
| −3 | K190290 | AltiVate Reverse Humeral Stem, 48mm | Encore Medical L.P. | 2019 | — |
| −2 | K202024 | ARROW Short Stem Humeral System | FH Industrie | 2021 | — |
| −1 | K253345 | JARVIS Diaphyseal Stem Standard | FH Industrie | 2025 | — |
| 0 (this device) | 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 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K202024 | ARROW Short Stem Humeral SystemSummary page 6…ed prosthesis) Panel: Orthopedic Product Code: PHX, HSD, KWS Primary Predicate: FH Industrie: ARROW Short Stem – K202024 Additional Predicate: FH Industrie – JARVIS Diaphyseal Stem Standard – K253345 Device Description: The JARVIS Metap… | 2021 |
| * | K253345 | JARVIS Diaphyseal Stem StandardSummary page 6…PHX, HSD, KWS Primary Predicate: FH Industrie: ARROW Short Stem – K202024 Additional Predicate: FH Industrie – JARVIS Diaphyseal Stem Standard – K253345 Device Description: The JARVIS Metaphyseal Stem is modification to the metaphysis component of the Arrow Short Stem prosthesi… | 2025 |
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
- 46 of the 165 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K202024.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PHX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHX
72in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHX
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHX
2,848in 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 (257 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 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 and JARVIS 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.
At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation. Metaphyseal stems and diaphyseal stems are intended for use without cement. The glenoid bases (metal-back or porous) are intended for cementless use with the addition of cortical and cancellous bone screws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254003: JARVIS Metaphyseal Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254003
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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