| K-number | K254003 |
| Device name | JARVIS Metaphyseal Stem |
| Applicant | FH Industrie |
| Product code | PHX |
| Device class | Class II |
| Decision date | Jan 9, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3660 |
The JARVIS Metaphyseal Stem is a shoulder joint prosthesis component designed for various shoulder conditions including humeral head necrosis, osteoarthritis, and rheumatoid polyarthritis. It is intended for use as part of a modular shoulder replacement system and can be used in simple humeral, total anatomical, and reverse shoulder prosthesis configurations depending on the patient's condition and rotator cuff function.
The device features optimized leading edges for easier impaction during surgery and includes suture holes for soft tissue reattachment. It is manufactured from medical-grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3 with a pure titanium plasma spray coating per ASTM F1580. The overall geometry falls within the range of the predicate device and maintains identical body pressfit characteristics.
ASTM F-136/ISO 5832-3 (titanium alloy material specifications) and ASTM F1580 (plasma spray coating specifications).
The indications for use, materials, and overall technology are identical to the predicate device (ARROW Short Stem). Although the subject device includes optimized leading edges and suture holes, engineering analysis determined these modifications do not introduce new worst-case conditions. The overall geometry remains within the predicate's range with identical pressfit, so previously performed testing on the predicate applies and no new mechanical testing was needed.
View the full FDA submission: accessdata.fda.gov