BIOMET BONE SCREW

K964970 · Biomet, Inc. · HWC · Apr 3, 1997 · Orthopedic

Device Facts

• Record ID: K964970
• Device Name: BIOMET BONE SCREW
• Applicant: Biomet, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Apr 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biomet Bone Screw is indicated for ankle fractures, metatarsal fusions and metatarsal osteotomies (Hallux Valgus).

Device Story

Bioresorbable bone screw for fixation of cancellous bone; indicated for ankle fractures, metatarsal fusions, and osteotomies. Device composed of LactoSorb resorbable copolymer (PLA/PGA). Implanted by surgeons during orthopedic procedures. Functions as mechanical fixation device; degrades in vivo via hydrolysis into lactic and glycolic acids; metabolized by body. Eliminates need for secondary removal surgery. Effectiveness established via mechanical testing and animal models comparing performance to stainless steel and PGA screws.

Clinical Evidence

No human clinical data. Effectiveness established via mechanical testing and histological animal studies. Animal model demonstrated healing equivalent to stainless steel screws with no adverse tissue response. Resorption confirmed complete by 15 months in vivo.

Technological Characteristics

Material: LactoSorb resorbable copolymer (polylactic acid (PLA) and polyglycolic acid (PGA)). Synthetic polyester. Biocompatible. Resorption mechanism: hydrolysis. Form factor: bone screw.

Indications for Use

Indicated for patients requiring fixation of cancellous bone, specifically for ankle fractures, metatarsal fusions, and metatarsal osteotomies (Hallux Valgus).

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, 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. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

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K964970
APR - 3 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

The Biomet Bone Screw is indicated for ankle fractures, metatarsal fusions and metatarsal osteotomies (Hallux Valgus).

The screws are made of a resorbable copolymer comprised of polylactic acid (PLA) and polyglycolic acid (PGA). In histological animal studies, the bone screw was completely resorbed by 15 months IN VIVO.

The Biomet Bone Screw is made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The safety of PLA/PGA material has been well documented since the early 1970's when the FDA first approved the use of resorbable PLA/PGA sutures. The exact same LactoSorb® material has been implanted in humans for over 10 years in a ligating clip. The LactoSorb® material has been found to be biocompatible in both soft tissue and bone tissue.

The effectiveness of the Biomet Bone Screw was determined by mechanical testing. The LactoSorb® screws were found to provide the same healing as a stainless steel screw in an animal model. There was no adverse tissue response to either the metal or LactoSorb® screws.

In summary the Biomet Bone Screw is safe and effective for fixation of cancellous bone. Mechanical testing demonstrated the Biomet Bone Screw to be as effective as the comparative metal and PGA resorbable cancellous screw.