FDA.reportPublic FDA data

TMINI® Guide Block Kit for Medacta® Knee System

Primary DI
M9461099731
Brand
TMINI® Guide Block Kit for Medacta® Knee System
Company
THINK SURGICAL, INC.
Model
109973
Catalog number
109973
Device description
TMINI® Guide Block Kit for Medacta® GMK® Sphere / SpheriKA Knee Systems, Ultimate Knee Instruments Only
Published
2025-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K230202000
K232802000
K241031000
K242264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230202000TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023-04-25OLO
K232802000TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023-10-12OLO
K241031000TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.2024-07-12OLO
K242264000TMINI Miniature Robotic SystemTHINK Surgical, Inc.2024-08-23OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9461099731PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(510)249-2300customerservice@thinksurgical.com

Regulatory Flags#

DUNS number
007211430
Device count
1
Kit
true
Lot or batch
true

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M946106298030Tsolution One Surgical System106298-032016-09-24
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