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U.S. Department of Health and Human Services

Product Classification

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Device pin, fixation, resorbable, hard tissue
Regulation Description Smooth or threaded metallic bone fixation fastener.
Definition Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.
Physical State Supplied with various surgical instruments, may include stainless steel applicator tube, wire, gauge, pin plunger, arthroscopic kit.
Technical Method This is a device that consists of a stiff wire segment or rod made of resorbable polymer and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. The device is intended to be implanted either through fracture fragments, intramedullary canal, or across a joint, and temporarily provide stabilization while healing or fusion occurs.
Target Area For various anatomic locations including knee, hand, finger and toe.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOVZ
Premarket Review Spinal Devices (DHT6B)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.3040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible