510(k) Report

FDA applicant

Tecres S.P.A.

Rockville, MD15 decisions2004–20250 recalls

FDA records 15 decisions for Tecres S.P.A. (Rockville, MD) from 2004 to 2025: 15 510(k) clearances. Most are in product codes NDN (Cement, Bone, Vertebroplasty) and KWL (Prosthesis, Hip, Hemi-, Femoral, Metal). Its devices cite 35 predicates, 9 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Tecres”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Tecres S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 12008: 22009: 12011: 22013: 12019: 12022: 12023: 12025: 1
2007high 2 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tecres S.P.A. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tecres S.P.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NDNCement, Bone, Vertebroplasty5decisions
  • KWLProsthesis, Hip, Hemi-, Femoral, Metal3decisions
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2decisions
  • LODBone Cement2decisions
  • HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2decisions
  • GXPMethyl Methacrylate For Cranioplasty1decision

Whose devices does it build on?

Its devices cite 35 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K042415Mendec SpineTecres S.P.A. · 20055cite it
  • K112983Spacer-STecres S.P.A. · 20114cite it
  • K062274Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321Tecres S.P.A. · 20083cite it
  • K101356Spacer-G and Spacer-KTecres S.P.A. · 20113cite it
  • K062452Kit Mendec Spine and Delivery SystemTecres S.P.A. · 20062cite it
  • K060535Spacer-S Temporary Shoulder SpacerTecres S.P.A. · 20062cite it

What has FDA decided for it lately?

  • K252326InterSpace GV Hip SpacerTecres S.P.A. · 2025
  • K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A. · 2023
  • K220131KYPHON VuE Bone CementTecres S.P.A. · 2022
  • K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATSTecres S.P.A. · 2019
  • K122175Mendec Spine HV, Mendec Spine HV SystemTecres S.P.A. · 2013
  • K112983Spacer-STecres S.P.A. · 2011
  • K101356Spacer-G and Spacer-KTecres S.P.A. · 2011
  • K092773Cemex Genta, Genta System and Genta System FastTecres S.P.A. · 2009

All 14 as Tecres S.P.A. →The one decision as Tecres →