TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee (10ea)

Basic Information

• Brand Name: TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee (10ea)
• Primary DI: M946109900J1
• Version / Model: 109900-J
• Catalog Number: 109900-J
• Company Name: THINK SURGICAL, INC.
• Labeler DUNS: 007211430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-24
• Public Version: 1
• Public Version Date: 2025-05-02
• Public Version Status: New
• Public Device Record Key: 2d6c962e-cabc-4af0-955b-65d41f983b54

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OLO	Orthopedic stereotaxic instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58910	Total knee prosthesis implantation guide-instrument kit	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M946109900J1	HIBCC

Customer Contacts

• Phone: [phone] ext. 1
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K230202	000
K232802	000
K241031	000
K242264	000
K243285	000