Osteotec SFI Instruments

Basic Information

• Brand Name: Osteotec SFI Instruments
• Primary DI: 05060183095793
• Version / Model: OSTF-Ins
• Catalog Number: OSTF-Ins
• Company Name: OSTEOTEC LIMITED
• Labeler DUNS: 348489386
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-26
• Public Version: 1
• Public Version Date: 2025-12-04
• Public Version Status: New
• Public Device Record Key: 5b6e61d7-88cd-49c9-9e44-06ef12cd17e6

Device Description

The Osteotec SFI Instruments device are a non-active, non-implantable, invasive device intended to be used as a tool for creating the correct size of cavity in the medullary canal to enable implantation of the Osteotec Silicone Finger Implant prosthesis during arthroplasty to replace the metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The Osteotec SFI Instruments are available in eleven evenly scaled sizes, numbered from size 00 to size 9, to match the available sizes of the definitive implant, the Osteotec Silicone Finger Implant. Each size has 2 rasps, one for creation of the proximal cavity and one for the distal cavity, therefore 22 rasps in total. The instrument set also includes an Awl, this creates an initial indent for the rasps to open up in stages. These eleven sizes and the Awl effectively constitute components of the Osteotec SFI Instruments, which is placed on the market as a single medical device.

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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44742	Joint prosthesis implantation kit, reusable	A collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060183095793	GS1