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Smart Correction 50-1031-01-WBNS

by Wishbone Medical Inc.

Smart Correction 50-1031-01-WBNS is a Class II device made by Wishbone Medical Inc., cleared under FDA 510(k) K193368 on 18 Sep 2020 and listed in FDA GUDID since 13 May 2021 (UDI-DI B56250103101WBNS0), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K193368

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 NumberB56250103101WBNS0 UDI-DI Date13 May 2021ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193368 Date18 Sep 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193368 decided 18 Sep 2020 Active
  • FDA GUDID UDI-DI B56250103101WBNS0 listed 13 May 2021 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1102-2023 FDA Class II initiated 4 Jan 2023

    Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction.

Timeline

3 dated events

  1. Cleared FDA 510(k) K193368
  2. Listed FDA GUDID B56250103101WBNS0
  3. Recall initiated FDA recalls Z-1102-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Smart Correction
Generic name
External orthopaedic fixation system, single-use
Model / reference
50-1031-01-WBNS
Primary DI / UDI-DI
B56250103101WBNS0
510(k) Number
FDA product code
KTT
GMDN term
External orthopaedic fixation system, single-use
Device class
Class II
Regulation number
888.3030
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Wishbone Medical Inc.

See all devices from Wishbone Medical Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)