510(k) Report

FDA applicant

Teknimed, S.A.

Round Rock, TX15 decisions2003–20242 recalls

FDA records 15 decisions for Teknimed, S.A. (Round Rock, TX) from 2003 to 2024: 15 510(k) clearances. Most are in product codes NDN (Cement, Bone, Vertebroplasty) and MQV (Filler, Bone Void, Calcium Compound). Its devices cite 23 predicates, 10 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Teknimed Sas”, “Teknimed”.

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 Teknimed, S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 12008: 12009: 22011: 22017: 12023: 12024: 1
2007high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • NDNCement, Bone, Vertebroplasty6decisions
  • MQVFiller, Bone Void, Calcium Compound4decisions
  • LYCBone Grafting Material, Synthetic2decisions
  • MBBBone Cement, Antibiotic1decision
  • MAIFastener, Fixation, Biodegradable, Soft Tissue1decision
  • LZNCement Obturator1decision

Whose devices does it build on?

Its devices cite 23 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 10 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.

  • K090435VertecemTeknimed, S.A. · 20094cite it
  • K043593Spine-Fix Biomimetic Bone CementTeknimed, S.A. · 20064cite it
  • K161114HIGH V+Teknimed Sas · 20172cite it
  • K103433F20Teknimed, S.A. · 20112cite it
  • K080873Opacity + Bone CementTeknimed, S.A. · 20082cite it
  • K031826TRIHA +Teknimed, S.A. · 20031cites it

What has FDA decided for it lately?

  • K242216Gentafix® (1, 3, 3MV)Teknimed Sas · 2024
  • K230394Euroscrew NG; Euroscrew TCP NGTeknimed · 2023
  • K161114HIGH V+Teknimed Sas · 20171 recall
  • K103816Cohesion Bone CementTeknimed Sas · 2011
  • K103433F20Teknimed, S.A. · 2011
  • K090435VertecemTeknimed, S.A. · 2009
  • K083005NangelTeknimed, S.A. · 2009
  • K080873Opacity + Bone CementTeknimed, S.A. · 2008

All 11 as Teknimed, S.A. →All 3 as Teknimed Sas →The one decision as Teknimed →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K161114HIGH V+ Spinal Cement System REF T040321KDec 15, 2022Class II
  • K031826OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part…Aug 31, 2006