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Digitizer 109005

by Think Surgical Inc.

Digitizer 109005 is a Class II device made by Think Surgical Inc., cleared under FDA 510(k) K241031 on 12 Jul 2024 (2 earlier submissions) and listed in FDA GUDID since 28 Aug 2023 (UDI-DI M9461090050), active as of 23 Oct 2026. One FDA recall is 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

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241031 Date12 Jul 2024DecidedStatusActive
United StatesGUDID listing NumberM9461090050 UDI-DI Date28 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241031 decided 12 Jul 2024 Active· +2 more in the status table
  • FDA GUDID UDI-DI M9461090050 listed 28 Aug 2023 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1318-2024 FDA Class II initiated 12 Feb 2024

    There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.

Timeline

5 dated events

  1. Cleared FDA 510(k) K230202
  2. Listed FDA GUDID M9461090050
  3. Cleared FDA 510(k) K232802
  4. Recall initiated FDA recalls Z-1318-2024
  5. Cleared FDA 510(k) K241031

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Digitizer
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
109005
Primary DI / UDI-DI
M9461090050
510(k) Number
FDA product code
OLO
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K230202)

and 8 more cleared under K230202

Cleared under the same submission (K232802)

and 8 more cleared under K232802

Similar devices in this category

Other devices filed under Orthopaedic prosthesis implantation positioning instrument, reusable.

Other devices from Think Surgical Inc.

See all devices from Think Surgical Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)