Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FH Industrie — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
496 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254003 | JARVIS Metaphyseal Stem | FH Industrie | 2026-01-09 | 25 | 0 |
| K253345 | JARVIS Diaphyseal Stem Standard | FH Industrie | 2025-10-29 | 29 | 0 |
| K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2025-08-28 | 27 | 0 |
| K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2024-11-25 | 117 | 0 |
| K232226 | ARROW Off-Centred Humeral Insert | FH Industrie | 2023-08-29 | 33 | 0 |
| K220758 | e-Ortho Shoulder Software v1.1 | FH Industrie | 2022-09-30 | 199 | 0 |
| K202024 | ARROW Short Stem Humeral System | FH Industrie | 2021-11-30 | 496 | 0 |
| K200127 | TELEGRAPH® EVOLUTION Humeral Nailing System | FH Industrie | 2020-10-01 | 254 | 0 |
| K201928 | e-Ortho Shoulder Software | FH Industrie | 2020-09-30 | 82 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda