Who is the manufacturer of DEPUY ADVANTAGE FIXATION SCREW SYSTEM?

Depuy, Inc. filed the 510(k) submission for DEPUY ADVANTAGE FIXATION SCREW SYSTEM (K961234).

What is the FDA product code for DEPUY ADVANTAGE FIXATION SCREW SYSTEM?

HWC. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for DEPUY ADVANTAGE FIXATION SCREW SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DEPUY ADVANTAGE FIXATION SCREW SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DEPUY ADVANTAGE FIXATION SCREW SYSTEM

Q: What are the predicate devices for DEPUY ADVANTAGE FIXATION SCREW SYSTEM?

DePuy M. Kurosaka™ Interference Screw; DePuy M. Kurosaka™ Fixation Screw; Arthrex Transtibial™ System.

K961234 · Depuy, Inc. · HWC · Jun 19, 1996 · Orthopedic

Device Facts

Record ID	K961234
Device Name	DEPUY ADVANTAGE FIXATION SCREW SYSTEM
Applicant	Depuy, Inc.
Product Code	HWC · Orthopedic
Decision Date	Jun 19, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The DePuy Advantage Fixation Screw System is intended to be used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.

Device Story

Titanium alloy cancellous bone screw; used for interference fixation of patellar bone-tendon-bone grafts during ACL reconstruction. Available in 7mm and 9mm diameters; cannulated and non-cannulated versions; various lengths. Features internal hex fitting for surgical insertion. Used by orthopedic surgeons in clinical/OR settings to secure grafts to bone, facilitating ligament reconstruction and joint stability.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparison to predicate devices.

Technological Characteristics

Material: Ti-6Al-4V alloy. Design: Fully threaded cancellous bone screw; 7mm and 9mm diameters; cannulated/non-cannulated; 29-degree tapered tip; round body thread; internal hex fitting. Finish: Polished satin.

Indications for Use

Indicated for interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.

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 Screw
DePuy M. Kurosaka™ Fixation Screw
Arthrex Transtibial™ System

Related Devices

K981670 — DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW · Depuy, Inc. · Jun 22, 1998
K021030 — TITANIUM CANNULATED INTERFERENCE SCREW · Future Medical Systems, Inc. · Jun 25, 2002
K982900 — PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW · Depuy, Inc. · Aug 31, 1998
K960704 — DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS · Depuy, Inc. · Jun 6, 1996
K980440 — DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW · Depuy, Inc. · Apr 3, 1998

Submission Summary (Full Text)

{0} JUN 19 1996 K961234 SUMMARY OF SAFETY AND EFFECTIVENESS EXHIBIT II NAME OF FIRM: DePuy Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 FIRM CONTACT: Sally Foust Clinical Research Specialist TRADE NAME: DePuy Advantage™ Fixation Screw System COMMON NAME: Bone Screw CLASSIFICATION: 888.3040 Smooth or threaded metallic bone fixation fastener DEVICE PRODUCT CODE: 87 HWC SUBSTANTIALLY EQUIVALENT DEVICES: DePuy M. Kurosaka™ Interference Screw DePuy M. Kurosaka™ Fixation Screw Arthrex Transtibial™ System DEVICE DESCRIPTION AND INTENDED USE: The DePuy Advantage Fixation screw is a fully threaded titanium alloy cancellous bone screw available in 7mm and 9mm diameters. Each diameter is available in six (6) lengths (15, 20, 25, 30, 35, and 40mm) in a cannulated version, and in five (5) lengths (20, 25, 30, 35, and 40mm) in a non-cannulated version. The Advantage screw has a polished satin finish, a 29 degree included angle tapered tip, a round body thread, and a radius on the socket end of the screw. Each screw has an internal hex fitting for instrument insertion during surgery. The DePuy Advantage Fixation Screw System is intended to be used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction. BASIS OF SUBSTANTIAL EQUIVALENCE: The DePuy Advantage Fixation Screw System screws are substantially equivalent to the DePuy M. Kurosaka Interference Screws cleared for fixation of bone-tendon-bone grafts in ACL reconstruction. All of the DePuy Advantage screws and the M. Kurosaka Interference screws are manufactured from Ti-6Al-4V alloy. All are available in 7mm and 9mm diameters in numerous lengths in cannulated and non-cannulated versions. （）