FH Industrie: FDA clearances and approvals
FH Industrie has 9 FDA 510(k) clearances (first 2020, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time: 82 days. Since 2017 its median was 82 days, against 130 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 2 | 168 |
| 2021 | 1 | 496 |
| 2022 | 1 | 199 |
| 2023 | 1 | 33 |
| 2024 | 1 | 117 |
| 2025 | 2 | 28 |
| 2026 | 1 | 25 |
Review time against the same product codes
Since 2017, FH Industrie's cleared 510(k)s took a median 82 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 6 | 6 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
Review panels
- Orthopedic (7)
- Radiology (2)
Most recent FH Industrie 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254003 | JARVIS Metaphyseal Stem | PHX | 2026-01-09 | 25 |
| K253345 | JARVIS Diaphyseal Stem Standard | PHX | 2025-10-29 | 29 |
| K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis | PHX | 2025-08-28 | 27 |
| K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | PHX | 2024-11-25 | 117 |
| K232226 | ARROW Off-Centred Humeral Insert | PHX | 2023-08-29 | 33 |
| K220758 | e-Ortho Shoulder Software v1.1 | LLZ | 2022-09-30 | 199 |
| K202024 | ARROW Short Stem Humeral System | PHX | 2021-11-30 | 496 |
| K200127 | TELEGRAPH® EVOLUTION Humeral Nailing System | HSB | 2020-10-01 | 254 |
| K201928 | e-Ortho Shoulder Software | LLZ | 2020-09-30 | 82 |
Recalls
openFDA lists no recalls under a recalling firm named FH Industrie.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does FH Industrie have?
FH Industrie has 9 FDA 510(k) clearances (first 2020, latest 2026), across 3 product codes in 2 review panels.
How long does FDA take to clear FH Industrie's 510(k)s?
The median time from FDA receipt to decision across FH Industrie's cleared 510(k)s is 82 days. Since 2017: 82 days, versus 130 days for all cleared 510(k)s in the same product codes.
What devices does FH Industrie make?
Its most frequent FDA product codes are PHX (Shoulder Prosthesis, Reverse Configuration, 6); LLZ (System, Image Processing, Radiological, 2); HSB (Rod, Fixation, Intramedullary And Accessories, 1).
Has FH Industrie had device recalls?
openFDA lists no recalls under a recalling firm name matching FH Industrie. Related entities may recall under other names.
Next steps
- See all 9 FH Industrie clearances with predicates and recalls
- Run predicate analysis for product code PHX, FH Industrie's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.