HANSSON PIN SYSTEM

K964893 · Osteonics Corp. · JDW · Feb 28, 1997 · Orthopedic

Device Facts

• Record ID: K964893
• Device Name: HANSSON PIN SYSTEM
• Applicant: Osteonics Corp.
• Product Code: JDW · Orthopedic
• Decision Date: Feb 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hansson Pin™ System is intended for the treatment of reducible intracapsular femoral neck fractures, i.e. subcapital and transcervical fractures, and has been designed to minimize surgical trauma to the patient and offer secure, stable fixation.

Device Story

Femoral neck fracture fixation device; consists of pre-assembled outer sleeve and inner sliding tongue. Two pins inserted into parallel drill holes through femoral neck into femoral head. Fixation achieved by intraoperatively pushing inner sliding tongue to extend hook through proximal window into subchondral bone. Used by surgeons in clinical/OR setting to provide stable fracture fixation; minimizes surgical trauma.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: ASTM F-138 Stainless Steel 316 LVM. Dimensions: 6.5mm diameter, 80mm-150mm lengths. Design: Two-part assembly (outer sleeve, inner sliding tongue) with subchondral bone hook fixation mechanism.

Indications for Use

Indicated for patients with reducible intracapsular femoral neck fractures, specifically subcapital and transcervical fractures.

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

• Howmedica Knowles Hip Pins (preamendment device)
• Zimmer Knowles Hip Pins (preamendment device)
• Howmedica Gouffon Hip Pin System (K760454)

Submission Summary (Full Text)

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FEB-26-1997 09:29 FROM OSTEONICS SCI & TECH TO 913018274349 P.04
K964893
FEB 28 1997

# 510(K) PREMARKET NOTIFICATION
## SUMMARY OF SAFETY AND EFFECTIVENESS
### HANSSON PIN™ SYSTEM

**Submission Information**

**Name and Address of the Sponsor of the 510(k) Submission:**
Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677
201-825-4900

**Contact Person:**
Donna S. Wilson
Regulatory Affairs Specialist

**Date Summary Prepared:**
February 26, 1997

**Device Identification**

**Proprietary Name:**
Hansson Pin™ System

**Common Name:**
Femoral Neck Fracture Fixation Device

**Classification Name and Reference:**
Smooth or Threaded Metallic Bone Fixation Fastener
21 CFR §888.3040

**Predicate Device Identification**
The Hansson Pin™ System is substantially equivalent to other legally marketed, Class II, femoral neck fracture fixation devices. The predicate devices are as follows: Howmedica Knowles Hip Pins (preamendment device), Zimmer Knowles Hip Pins (preamendment device), and Howmedica Gouffon Hip Pin System (K760454).

**Device Description**
The Hansson Pin™ System is a femoral neck fracture fixation device. Each pin consists of two parts: an outer sleeve and an inner sliding tongue, and is provided pre-assembled. The outer sleeve features a proximal window, where the inner sliding tongue's hook protrudes when properly introduced. Two pins are inserted into parallel drill holes through the femoral neck and into the femoral head. Fixation of the pin in the femoral head is achieved when the inner sliding tongue is intraoperatively pushed up partially through the proximal window, and the end hook curls around into the subchondral bone. The pins measure 6.5mm in diameter, are available in lengths ranging from 80mm to 150mm, and are made of ASTM F-138 Stainless Steel 316 LVM.

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FEB-26-1997 09:29 FROM OSTEONICS SCI & TECH TO 913018274349 P.05

## Intended Use
The Hansson Pin™ System is intended for the treatment of reducible intracapsular femoral neck fractures, i.e. subcapital and transcervical fractures, and has been designed to minimize surgical trauma to the patient and offer secure, stable fixation.

## Statement of Technological Comparison
The subject device shares the same materials, intended use, and basic surgical preparation and insertion procedures as that of the predicate devices. Though the method of fixation for the subject device differs from that of the predicate devices, testing performed substantiates the use of the subchondral bone end hook design for fixation of the pins.