I.T.S. GmbH: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “I.T.S. GmbH” (first 2013, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 122 days. Since 2017 the median was 122 days, against 104 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 2 | 115 |
| 2014 | 2 | 99 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 520 |
| 2023 | 0 | — |
| 2024 | 1 | 138 |
| 2025 | 0 | — |
| 2026 | 2 | 96 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name I.T.S. GmbH took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 6 | 6 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
Review panels
- Orthopedic (8)
Most recent I.T.S. GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L | HRS | 2026-06-16 | 85 |
| K260054 | I.T.S. PRS Phoenix II | HRS | 2026-04-24 | 106 |
| K233134 | I.T.S. INS Proximal Femur Nail | HSB | 2024-02-12 | 138 |
| K210935 | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) | HRS | 2022-08-31 | 520 |
| K142418 | I.T.S. Hand Locking Plates System - HLS | HRS | 2014-09-26 | 29 |
| K132945 | CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL | HSB | 2014-03-07 | 169 |
| K131722 | I.T.S. EXTREMITY FIXATION SYSTEMS | HRS | 2013-08-07 | 56 |
| K130008 | DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING | HRS | 2013-06-25 | 174 |
Recalls
18 product recalls in 2 recall events; 17 initiated in the last five years. Most recent: 2026-01-23.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under I.T.S. GmbH?
FDA lists 8 510(k) clearances under the applicant name “I.T.S. GmbH” (first 2013, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by I.T.S. GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name I.T.S. GmbH is 122 days. Since 2017: 122 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under I.T.S. GmbH?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 6); HSB (Rod, Fixation, Intramedullary And Accessories, 2).
Next steps
- See all 8 I.T.S. GmbH clearances with predicates and recalls
- Run predicate analysis for product code HRS, I.T.S. GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.