Tecres S.P.A.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Tecres S.P.A.” (first 2005, latest 2025), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 169 days. Since 2017 the median was 194 days, against 88 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 248 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 299 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 90 |
| 2023 | 1 | 630 |
| 2024 | 0 | — |
| 2025 | 1 | 12 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tecres S.P.A. took a median 194 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NDN | Cement, Bone, Vertebroplasty | 5 | 5 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 3 | 3 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 2 | 2 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| LOD | Bone Cement | 2 | 2 |
Review panels
- Orthopedic (14)
Most recent Tecres S.P.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252326 | InterSpace GV Hip Spacer | KWL | 2025-08-06 | 12 |
| K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LV | LOD | 2023-01-09 | 630 |
| K220131 | KYPHON VuE Bone Cement | NDN | 2022-04-18 | 90 |
| K181732 | InterSpace Knee Extra-Large Size, InterSpace Knee ATS | JWH | 2019-04-27 | 299 |
| K122175 | MENDEC SPINE HV, MENDEC SPINE HV SYSTEM | NDN | 2013-03-28 | 248 |
| K112983 | SPACER-S | HSD | 2011-12-12 | 67 |
| K101356 | Spacer-G and Spacer-K | KWL | 2011-09-20 | 494 |
| K092773 | CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST | LOD | 2009-11-24 | 76 |
| K062274 | SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321 | JWH | 2008-05-22 | 654 |
| K062273 | SPACER-G TEMPORARY HIP PROSTHESIS | KWL | 2008-05-22 | 654 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tecres S.P.A..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tecres (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tecres S.P.A.?
FDA lists 14 510(k) clearances under the applicant name “Tecres S.P.A.” (first 2005, latest 2025), across 5 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 Tecres S.P.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tecres S.P.A. is 169 days. Since 2017: 194 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tecres S.P.A.?
The most frequent FDA product codes under this applicant name are NDN (Cement, Bone, Vertebroplasty, 5); KWL (Prosthesis, Hip, Hemi-, Femoral, Metal, 3); HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, 2).
Next steps
- See all 14 Tecres S.P.A. clearances with predicates and recalls
- Run predicate analysis for product code NDN, Tecres S.P.A.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.