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Ibs™ S25 ST212

by IN2BONES

Ibs™ S25 ST212 is a Class II device made by IN2BONES, cleared under FDA 510(k) K131920 on 1 May 2014 and listed in FDA GUDID since 28 Aug 2015 (UDI-DI 03760225712306), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K131920

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760225712306 UDI-DI Date28 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131920 Date1 May 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131920 decided 1 May 2014 Active
  • FDA GUDID UDI-DI 03760225712306 listed 28 Aug 2015 Listed

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1319-2024 FDA Class II initiated 26 Jan 2024
    • Ongoing Z-1320-2024 FDA Class II initiated 26 Jan 2024

    This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.

    • Terminated Z-0397-2016 FDA Class II initiated 18 Nov 2015

    One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.

Timeline

5 dated events

  1. Cleared FDA 510(k) K131920
  2. Listed FDA GUDID 03760225712306
  3. Recall initiated FDA recalls Z-0397-2016
  4. Recall initiated FDA recalls Z-1319-2024
  5. Recall initiated FDA recalls Z-1320-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ibs™
Generic name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
S25 ST212
Primary DI / UDI-DI
03760225712306
510(k) Number
FDA product code
HWC
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Size
Length — 12 Millimeter
Outer Diameter — 2.5 Millimeter

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K131920)

and 8 more cleared under K131920

Similar devices in this category

Other devices filed under Orthopaedic bone screw (non-sliding).

Other devices from IN2BONES

See all devices from IN2BONES →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)