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OS2-V Varisation Staple

by In2Bones SAS

510(k) K143323

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143323↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK143323 Date26 Feb 2015ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143323 decided 26 Feb 2015 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
JDR
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The OS2-V Varisation Staple is a surgical fixation device classified as an orthopedic staple, designed for use in Akin type osteotomies. It provides internal fixation to stabilize bone fragments during corrective procedures, ensuring proper alignment and varus angulation.

This device is supplied sterile, pre-loaded onto its inserter, and includes a drill guide packaged with the implant. Available in interaxis sizes of 8 mm or 10 mm with angles of 26° or 90°, it is intended for single-use applications. The OS2-V Varisation Staple holds FDA 510(k) clearance under the Medical Devices Directive (MDD) and is intended for use with single-use instruments.

Devices cleared under K143323

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K143323
UDI-DISize and differences
OS2®-V T10 SS260
In2Bones, USA
T10 SS260 / T10 SS26003760225710807
Angle 26 deg
On the market
OS2®-V T10 SS268
In2Bones, USA
T10 SS268 / T10 SS26803760225710814
Angle 26 deg
On the market
OS2®-V T10 SS900
In2Bones, USA
T10 SS900 / T10 SS90003760225710821
Angle 90 deg
On the market
OS2®-V T10 SS908
In2Bones, USA
T10 SS908 / T10 SS90803760225710838
Angle 90 deg
On the market

Similar devices

Other devices filed under FDA product code JDR (Staple, Fixation, Bone).

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