TMINI® Guide Block Kit compatible with Stryker® Triathlon® Knee System

Primary DI
M9461100251
Brand
TMINI® Guide Block Kit compatible with Stryker® Triathlon® Knee System
Company
THINK SURGICAL, INC.
Model
110025
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253661000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253661000TMINI Miniature Robotic SystemTHINK Surgical, Inc.2025-12-22OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9461100251PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Total knee prosthesis implantation guide-instrument kitA collection of sterile hand-held surgical instruments intended to be used during total knee arthroplasty (TKA), either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. Components may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components; the implant is not included. This is a single-use device.

Regulatory Flags#

DUNS number
007211430
Device count
1
Lot or batch
true

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