Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Tecres S.P.A. — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

248 daysmedian FDA review time

654 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K252326	InterSpace GV Hip Spacer	Tecres S.P.A.	2025-08-06	12
K211163	Bone Cement Genta, Bone Cement HV, Bone Cement LV	Tecres S.P.A.	2023-01-09	630
K220131	KYPHON VuE Bone Cement	Tecres S.P.A.	2022-04-18	90
K181732	InterSpace Knee Extra-Large Size, InterSpace Knee ATS	Tecres S.P.A.	2019-04-27	299
K122175	MENDEC SPINE HV, MENDEC SPINE HV SYSTEM	Tecres S.P.A.	2013-03-28	248
K112983	SPACER-S	Tecres S.P.A.	2011-12-12	67
K101356	Spacer-G and Spacer-K	Tecres S.P.A.	2011-09-20	494
K092773	CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST	Tecres S.P.A.	2009-11-24	76
K062273	SPACER-G TEMPORARY HIP PROSTHESIS	Tecres S.P.A.	2008-05-22	654
K062274	SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK00	Tecres S.P.A.	2008-05-22	654
K063438	VSPSPN	Tecres S.P.A.	2007-01-17	64
K062452	KIT MENDEC SPINE AND DELIVERY SYSTEM	Tecres S.P.A.	2006-09-21	30
K060535	SPACER-S TEMPORARY SHOULDER SPACER	Tecres S.P.A.	2006-05-24	85
K042415	MENDEC SPINE	Tecres S.P.A.	2005-06-09	275

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