HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM

K962314 · Osteonics Corp. · KWP · Dec 9, 1996 · Orthopedic

Device Facts

• Record ID: K962314
• Device Name: HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM
• Applicant: Osteonics Corp.
• Product Code: KWP · Orthopedic
• Decision Date: Dec 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject devices are intended for single use and are indicated for patients with cervical subluxations and dislocations from C1-C7 to achieve posterior cervical stabilization.

Device Story

Spinal fixation system; provides posterior cervical stabilization. Components: threaded and unthreaded clamps (3 sizes: C1, 7mm, 13mm) and threaded screws (3 lengths: 10mm, 20mm, 30mm). Used by surgeons in clinical settings to secure cervical vertebrae. Device stabilizes spine following subluxation or dislocation; prevents further displacement; facilitates fusion/healing.

Clinical Evidence

No clinical data; bench testing only (based on identity to predicate).

Technological Characteristics

Materials: Titanium alloy (clamps), commercially pure titanium (screws). Form factor: Interlaminar clamp system with threaded/unthreaded components. Single-use.

Indications for Use

Indicated for patients with cervical subluxations and dislocations from C1-C7 requiring posterior cervical stabilization.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• AME® Halifax® Plus Interlaminar Clamp System (K850039)

Submission Summary (Full Text)

{0}

DEC -8 1996
K962314

# 510(k) Notification
## Summary of Safety and Effectiveness
### for the
## Osteonics® Halifax® Plus Interlaminar Clamp System

## Submission Information

| Name and Address of the Sponsor
of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
| --- | --- |
| Contact Person: | Chuck Ryan
Regulatory Affairs Team Leader |
| Date of Summary Preparation: | June 10, 1996 |

## Device Identification

| Proprietary Name: | Osteonics® Halifax® Plus Interlaminar Clamp System |
| --- | --- |
| Common Name: | Spinal Fixation Components |
| Classification Name/Reference: | Spinal Interlaminal Fixation Orthosis
21 CFR §888.3050 |

## Predicate Device Identification:

The components of the Osteonics® Halifax® Plus Interlaminar Clamp System are identical and thus substantially equivalent to those of the AME® Halifax® Plus Interlaminar Clamp System, which was determined substantially equivalent by the U.S. Food and Drug Administration (FDA) via 510(k) Premarket Notification #K850039. (Note: In K850039, the AME® Halifax® Plus Interlaminar Clamp System was identified as the Halifax Spinal Clamp System, manufactured by AME’s predecessor, Levtech, Inc.)

## Description of Devices:

The Osteonics® Halifax® Plus Interlaminar Clamp System consists of three sizes (C1, 7mm, and

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13mm) of threaded and matching unthreaded clamps made from titanium alloy. The system also features three lengths (10, 20, and 30 mm) of associated threaded screws made from commercially pure titanium and used to secure the aforementioned sets of matching threaded and unthreaded clamps.

## Intended Use:

The subject devices are intended for single use and are indicated for patients with cervical subluxations and dislocations from C1-C7 to achieve posterior cervical stabilization.

## Statement of Technological Comparison:

The designs, materials, intended use, and general manufacturing processes characterizing the components of the Osteonics® Halifax® Plus Interlaminar Clamp System are identical to those of the predicate AME® Halifax® Plus Interlaminar Clamp System.

## Performance Data:

As the components of the Osteonics® Halifax® Plus Interlaminar Clamp System remain identical to those of the previously marketed, predicate AME® Halifax® Plus Interlaminar Clamp System, which has been determined substantially equivalent via 510(k) Premarket Notification #K850039, no additional performance data is deemed necessary.

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