510(k) Report

FDA applicant

Linvatec Biomaterials, Ltd.

Tampere, FI8 decisions2003–20050 recalls

FDA records 8 decisions for Linvatec Biomaterials, Ltd. (Tampere, FI) from 2003 to 2005: 8 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and MAI (Fastener, Fixation, Biodegradable, Soft Tissue). Its devices cite 29 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Linvatec Biomaterials, Inc.”.

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 Linvatec Biomaterials, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Linvatec Biomaterials, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Linvatec Biomaterials, Ltd. 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?

  • HWCScrew, Fixation, Bone4decisions
  • MAIFastener, Fixation, Biodegradable, Soft Tissue2decisions
  • JEYPlate, Bone1decision
  • HTYPin, Fixation, Smooth1decision

Whose devices does it build on?

Its devices cite 29 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 2 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.

  • K052080Matryx Interference ScrewLinvatec Biomaterials, Inc. · 20054cite it
  • K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T…Linvatec Biomaterials, Inc. · 20043cite it
  • K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218HLinvatec Biomaterials, Ltd. · 20042cite it
  • K041288Modification to SmartpinLinvatec Biomaterials, Inc. · 20042cite it
  • K042295Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020Linvatec Biomaterials, Ltd. · 20041cites it
  • K0319812.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd. · 20031cites it

What has FDA decided for it lately?

  • K052080Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
  • K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218HLinvatec Biomaterials, Ltd. · 2004
  • K042517Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsLinvatec Biomaterials, Ltd. · 2004
  • K042295Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020Linvatec Biomaterials, Ltd. · 2004
  • K041288Modification to SmartpinLinvatec Biomaterials, Inc. · 2004
  • K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T…Linvatec Biomaterials, Inc. · 2004
  • K032447Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedLinvatec Biomaterials, Ltd. · 2004
  • K0319812.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd. · 2003

All 5 as Linvatec Biomaterials, Ltd. →All 3 as Linvatec Biomaterials, Inc. →

Other applicant names beginning “Linvatec”

FDA records each applicant name separately; these may or may not be the same firm.

Linvatec Corp. 93Linvatec Corporation D/B/A Conmed Linvatec 4