DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS

K960704 · Depuy, Inc. · HWC · Jun 6, 1996 · Orthopedic

Device Facts

• Record ID: K960704
• Device Name: DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS
• Applicant: Depuy, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jun 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Advantage Magnum Interference Screws are intended to provide early rigid fixation and stability of the bone block in bone/ patellar tendon/ bone graft surgical procedures for Anterior Cruciate Ligament (ACL) reconstruction. They are specifically intended for use in bone tunnels which have been enlarged due to tunnel/graft mismatch or revision of a prior ACL reconstruction.

Device Story

Advantage Magnum Interference Screws; fully threaded, cannulated, titanium alloy cancellous bone screws. Used for bone/patellar tendon/bone graft fixation in ACL reconstruction. Features tapered self-tapping tip; hex drive broached into minor diameter for low-profile, headless design. Minimizes subcutaneous protrusions. Used by orthopedic surgeons in clinical/OR settings to provide rigid fixation and stability in enlarged bone tunnels. Benefits patient by securing graft during healing process.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material comparison.

Technological Characteristics

Material: Titanium alloy. Design: Fully threaded, cannulated, cancellous bone screw. Features: Tapered self-tapping tip, hex drive, headless low-profile design. Dimensions: 11, 13, 15mm diameters; 15, 20, 25, 30mm lengths.

Indications for Use

Indicated for patients undergoing Anterior Cruciate Ligament (ACL) reconstruction requiring bone/patellar tendon/bone graft fixation, specifically in cases of enlarged bone tunnels due to tunnel/graft mismatch or revision surgery.

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.

Predicate Devices

• DePuy M. Kurosaka Interference Screws

Submission Summary (Full Text)

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K960704

# SUMMARY OF SAFETY AND EFFECTIVENESS

JUN - 6 1996

NAME OF FIRM:
DePuy Inc.
P.O. Box 988
Warsaw, IN 46581-0988

510(k) CONTACT:
Cheryl Hastings
Manager of Pre-clinical Device Evaluation

TRADE NAME:
Advantage Magnum Interference Screws

CLASSIFICATION NAME:
Smooth or threaded metallic bone fixation fastener

COMMON NAME:
Bone/tendon/bone interference fixation screw

SUBSTANTIALLY EQUIVALENT DEVICE:
DePuy M. Kurosaka Interference Screws

DEVICE DESCRIPTION:
The Advantage Magnum Screw is a fully threaded, cannulated, Titanium alloy, cancellous bone screw, available in diameters of 11, 13 and 15mm and in lengths of 15, 20, 25 and 30mm. The tip of the screw is tapered to a point which produces the self-tapping feature of the screw. The screw is inserted by a hex drive which is broached into the minor diameter of the screw itself which minimizes the size of the head of the screw. The headless, low profile design minimizes subcutaneous surface protrusions. The large cancellous threads are a symmetrical thread form with a smooth radius at the base of the threads.

INTENDED USE:
The Advantage Magnum Interference Screws are intended to provide early rigid fixation and stability of the bone block in bone/ patellar tendon/ bone graft surgical procedures for Anterior Cruciate Ligament (ACL) reconstruction. They are specifically intended for use in bone tunnels which have been enlarged due to tunnel/graft mismatch or revision of a prior ACL reconstruction.

SUBSTANTIAL EQUIVALENCE:
The Advantage Magnum Interference Screws are manufactured from the same material and have the same intended use as the DePuy M. Kurosaka Interference Screws. The only significant difference between the two designs is that the Advantage Magnum Interference Screws have larger diameters and are available in a shorter length than the M. Kurosaka Screws. Due to their increased diameter, the mechanical performance of the Advantage Magnum Screws is expected to be equal to or better than that of the M. Kurosaka Screws.

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