Who is the manufacturer of THREADED FIXATION PIN?

Orthopaedic Biosystems, Ltd. filed the 510(k) submission for THREADED FIXATION PIN (K963433).

What is the FDA product code for THREADED FIXATION PIN?

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

What is the regulatory pathway for THREADED FIXATION PIN?

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

Who can help prepare an FDA 510(k) submission like THREADED FIXATION PIN?

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.

THREADED FIXATION PIN

K963433 · Orthopaedic Biosystems, Ltd. · JDW · Nov 6, 1996 · Orthopedic

Device Facts

Record ID	K963433
Device Name	THREADED FIXATION PIN
Applicant	Orthopaedic Biosystems, Ltd.
Product Code	JDW · Orthopedic
Decision Date	Nov 6, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Threaded Fixation Pin is intended for internal alignment and fixation for small bones of the hand and foot.

Device Story

Threaded fixation pin; titanium alloy construction; used for internal alignment and fixation of small bones in hand and foot; functions similarly to predicate Kirschner wires; physician-operated in clinical setting; provides mechanical stabilization of bone fragments.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Titanium alloy. Form factor: Threaded pin. Function: Internal bone fixation. No electronic or software components.

Indications for Use

Indicated for internal alignment and fixation of small bones in the hand and foot.

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

Synthes Threaded Kirschner Wires

Related Devices

K982931 — THREADED FIXATION PIN · Sgarlato Laboratories, Inc. · Oct 21, 1998
K051740 — TAPERED COMPRESSION PIN · Nexa Orthopedics, Inc. · Sep 6, 2005
K131264 — KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS · Gebr. Brasseler GmbH & Co. KG · Jul 26, 2013
K121004 — APEX KIRSCHNER WIRES AND STEINMANN PINS · Apex Tools & Orthopedics Co. · Apr 24, 2012
K083490 — BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 · Biopro, Inc. · Mar 18, 2009

Submission Summary (Full Text)

{0} K963433 NOV - 6 1996 # Threaded Fixation Pin 510(k)Summary - Safety and Effectiveness The proposed device, the Threaded Fixation Pin claims substantial equivalence to a currently marketed device, Synthes Threaded Kirschner Wires. The Synthes Threaded Kirschner Wires and the proposed device are available in Titanium Alloy. Both function as internal alignment and fixation for small bones of the hand and foot and have no significant design differences. 510K-3.WPD Page 5 of 5