PolyLock Midfoot

Basic Information

• Brand Name: PolyLock Midfoot
• Primary DI: 00840124520158
• Version / Model: TN-MF-5027
• Catalog Number: TN-MF-5027
• Company Name: FUSION ORTHOPEDICS, LLC
• Labeler DUNS: 080307067
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-16
• Public Version: 1
• Public Version Date: 2025-05-26
• Public Version Status: New
• Public Device Record Key: ca41b821-3b44-4ac3-873e-bdcf31469695

Device Description

2.7mm Locking Turret

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QAC	Screw Sleeve Bone Fixation Device	Orthopedic	888.3043	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66365	Bone screw fixation sleeve	An implantable tube-like sleeve intended to provide a secure fixing for a bone screw (e.g. orthopaedic, spinal) which has lost purchase due to screw loosening, back out, or breakage. It is inserted into the screw hole so that when a screw is inserted, a mechanical wedge is created as it is tightened. The sleeve is made of a non-bioabsorbable polymer and sleeve size is adjusted/configured intraoperatively. Disposable devices associated with implantation may be supplied with the sleeve.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840124520158	GS1

Premarket Submissions

Submission Number	Supplement Number
K211843	000