Who is the manufacturer of DEPUY CANNULATED CROSS PIN SCREW SYSTEM?

Depuy, Inc. submitted the Traditional clearance for DEPUY CANNULATED CROSS PIN SCREW SYSTEM (K963973).

What is the FDA product code for DEPUY CANNULATED CROSS PIN SCREW SYSTEM?

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

What is the regulatory pathway for DEPUY CANNULATED CROSS PIN SCREW SYSTEM?

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

What are the predicate devices for DEPUY CANNULATED CROSS PIN SCREW SYSTEM?

DePuy Titanium Cross Pin Screw System (K954630); DePuy Cross Pin Screw System (K946228); Arthrex SemiFix ACL Reconstruction System.

DEPUY CANNULATED CROSS PIN SCREW SYSTEM

K963973 · Depuy, Inc. · JDW · Dec 16, 1996 · Orthopedic

Device Facts

Record ID	K963973
Device Name	DEPUY CANNULATED CROSS PIN SCREW SYSTEM
Applicant	Depuy, Inc.
Product Code	JDW · Orthopedic
Decision Date	Dec 16, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The DePuy Cannulated Cross Pin Screws are intended to provide early fixation of autogenous or allogeneic tendon grafts in surgical procedures for anterior cruciate ligament (ACL) reconstruction.

Device Story

Cannulated cross pin screws; titanium alloy; headless; proximally threaded; smooth shanks with two tapers; blunt distal tip. Used in ACL reconstruction; provides early fixation of autogenous or allogeneic tendon grafts. Operated by orthopedic surgeons in OR. Cannulated design allows use with guide pins. Available in 45mm-75mm lengths. Benefits include secure graft fixation during ligament reconstruction.

Clinical Evidence

Bench testing only.

Technological Characteristics

Titanium alloy; cannulated; headless; proximally threaded; smooth shanks with dual tapers; blunt distal tip; lengths 45-75mm.

Indications for Use

Indicated for patients undergoing anterior cruciate ligament (ACL) reconstruction requiring fixation of autogenous or allogeneic tendon grafts.

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 Titanium Cross Pin Screw System (K954630)
DePuy Cross Pin Screw System (K946228)
Arthrex SemiFix ACL Reconstruction System

Related Devices

K961234 — DEPUY ADVANTAGE FIXATION SCREW SYSTEM · Depuy, Inc. · Jun 19, 1996
K960704 — DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS · Depuy, Inc. · Jun 6, 1996
K981670 — DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW · Depuy, Inc. · Jun 22, 1998
K021351 — BIOSTEON CROSS PIN · Biocomposites, Ltd. · Oct 17, 2002
K182955 — EZStart Interference Screw · Conmed Corporation · Jan 22, 2019

Submission Summary (Full Text)

{0} K963973 # SUMMARY OF SAFETY AND EFFECTIVENESS DEC 16 1996 ## NAME OF FIRM: DePuy Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 ## FIRM CONTACT: Arlene Saull, RAC Manager, Medical Device Submissions ## TRADE NAME: DePuy Cannulated Cross Pin Screw System ## COMMON NAME: Threaded fixation pin ## CLASSIFICATION: Smooth or threaded metallic bone fixation fastener (21 CFR Part 888.3040) Class II ## DEVICE PRODUCT CODE: 87 JDW Pin, Threaded ## SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Titanium Cross Pin Screw System DePuy Cross Pin Screw System Arthrex SemiFix ACL Reconstruction System ## DEVICE DESCRIPTION AND INTENDED USE: The DePuy Cannulated Cross Pin Screw System contains cross pin screws manufactured from titanium alloy which are headless, proximally threaded with smooth shanks containing two tapers; the most distal taper being the smaller diameter tapering to a blunt tip. They are cannulated for use with their accompanying guide pins. The cross pin screws will be available in seven lengths ranging from 45mm to 75mm in 5mm increments. The DePuy Cannulated Cross Pin Screws are intended to provide early fixation of autogenous or allogeneic tendon grafts in surgical procedures for anterior cruciate ligament (ACL) reconstruction. ## BASIS OF SUBSTANTIAL EQUIVALENCE: The DePuy Cannulated Cross Pin Screw System is substantially equivalent to the DePuy Titanium Cross Pin Screw System (K954630), the DePuy Cross Pin System (K946228), and the Arthrex SemiFix ACL Reconstruction System. The substantial equivalency is based on similar material, intended uses and design. 1 OR