K Number
K964970
Device Name
BIOMET BONE SCREW
Manufacturer
Date Cleared
1997-04-03

(112 days)

Product Code
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bone Screw is indicated for ankle fractures, The Biomet metatarsal fusions and metatarsal osteotomies (Hallux Valgus).
Device Description
The screws are made of a resorbable copolymer comprised of polylactic acid (PLA) and polyglycolic acid (PGA).
More Information

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Not Found

No
The summary describes a resorbable bone screw and its mechanical testing, with no mention of AI or ML.

Yes
Healing ankle fractures, metatarsal fusions, and metatarsal osteotomies is a therapeutic intervention.

No
The device description and intended use indicate it is a bone screw used for surgical fixation in treating ankle fractures and metatarsal conditions, not for diagnosing them. The performance studies also focus on mechanical testing and healing effectiveness, not diagnostic capabilities.

No

The device description explicitly states the screws are made of a resorbable copolymer, indicating a physical hardware component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVDs are used to examine specimens from the human body. The description clearly states the device is a "Bone Screw" intended for surgical implantation to treat bone fractures and deformities. It is a physical implant, not a tool for analyzing biological samples.
  • The intended use is for surgical fixation. The indications for use are specific surgical procedures (ankle fractures, metatarsal fusions, metatarsal osteotomies).
  • The device description is of a physical implant. It describes the material and form of the screw.
  • The performance studies are mechanical testing and animal model studies. These are relevant to the structural integrity and biological compatibility of an implant, not the analytical performance of a diagnostic test.

Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

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Device Description

The screws are made of a resorbable copolymer comprised of polylactic acid (PLA) and polyglycolic acid (PGA).

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

ankle, metatarsal, cancellous bone

Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
Mechanical testing demonstrated the Biomet Bone Screw to be as effective as the comparative metal and PGA resorbable cancellous screw.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.

0

K964970

APR - 3 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

Bone Screw is indicated for ankle fractures, The Biomet 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.

bioresorbable The Biomet Bone Screw is made of 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.