510(k) Report

FDA applicant

THINK Surgical, Inc.

Fremont, CA24 decisions2015–20263 recalls

FDA records 24 decisions for THINK Surgical, Inc. (Fremont, CA) from 2015 to 2026: 24 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 40 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 21 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided THINK Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2015: 12016: 22017: 12019: 32020: 32021: 22023: 22024: 32025: 42026 (partial year): 3
2015high 4 (2025) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

2in 2026

2024: 12026 (partial year): 2
2015high 2 (2026) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — THINK Surgical, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like THINK Surgical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OLOOrthopedic Stereotaxic Instrument20decisions
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories3decisions
  • OJPOrthopedic Computer Controlled Surgical System1decision

How long do its 510(k) reviews take?

Since 2016, its 23 510(k)s took a median of 40 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 109 days; 18 of its 23 were faster than that.

Whose devices does it build on?

Its devices cite 25 predicates; 21 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 24 times; 21 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.

  • K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 20193cite it
  • K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 20202cite it
  • K200632TCAT TKA Instrument Tray SetTHINK Surgical, Inc. · 20202cite it
  • K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 20251cites it
  • K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 20231cites it
  • K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 20191cites it

What has FDA decided for it lately?

  • K263234TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2026
  • K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 20261 recall
  • K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc. · 20261 recall
  • K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2025
  • K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2025
  • K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2025
  • K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2025
  • K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2024

All 24 as THINK Surgical, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K261024Think Surgical Square Driver REF: 109126Aug 20, 2026Class II
  • K260010TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking…May 8, 2026Class II
  • K230202Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used…Feb 12, 2024Class II