SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT

K082795 · Interventional Spine, Inc. · MRW · Dec 12, 2008 · OR

Device Facts

• Record ID: K082795
• Device Name: SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT
• Applicant: Interventional Spine, Inc.
• Product Code: MRW · OR
• Decision Date: Dec 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The 4.5mm BONE-LOK® PLS IMPLANT is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis, or failed previous fusion. The intended use of the 4.5mm BONE-LOK® PLS Implant is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 4.5mm BONE-LOK® PLS Implant may be used to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construction as an aid to fusion. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm BONE-LOK® PLS Implant is intended for lumbar bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the 4.5mm BONE-LOK® PLS Implant.

Device Story

System consists of 4.5mm BONE-LOK® PLS double-helix titanium alloy screw with compression-locking collar and disposable manual surgical instruments. Used by surgeons to stabilize lumbar spine (L1-S1) via bilateral facet joint immobilization; aids fusion; can supplement anterior fusion products. Screws inserted posteriorly through superior facet, across joint, into pedicle. Provided sterile; reusable compression tool sterilized via steam autoclave on-site.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarity to predicate devices.

Technological Characteristics

Double-helix screw with compression-locking collar; medical grade titanium alloy; manual surgical instruments; sterile (implants/disposables) and non-sterile (reusable tool) components; steam autoclave sterilization for reusable tools.

Indications for Use

Indicated for patients with spondylolisthesis, spondylolysis, degenerative disc disease (discogenic back pain), facet degeneration with instability/fracture, pseudoarthrosis, or failed previous fusion requiring lumbar bilateral facet fixation (L1-S1).

Predicate Devices

• Triage Medical Disposable Posterior Lumbar Stabilization (PLS) Procedure Kit (K062391)
• Triage Medical BONE-LOK® 4.5mm Facet Screw and BONE-LOK® FS Instrument Kit (K043351)
• TranS1® Facet Screws (K073515)

Submission Summary (Full Text)

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#### SECTION 5 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## SUBMITTER INFORMATION

| A. | Company Name: | Interventional Spine, Inc |
|----|--------------------|------------------------------------------------------|
| B. | Company Address: | 13700 Alton Parkway<br>Suite 160<br>Irvine, CA 92618 |
| C. | Company Phone: | [phone] |
| D. | Company Facsimile: | [phone] |

ய் Contact Person: Carol Emerson

# DEVICE IDENTIFICATION

| A. | Trade Name: | Single Use PERPOS™ PLS System,<br>BONE-LOK® PLS Implant |
|----|----------------------|-----------------------------------------------------------|
| B. | Catalog Number: | 9045-01, 9045-02, LSW-45-3040 |
| C. | Common Name: | Facet Screw and associated manual<br>surgical instruments |
| D. | Classification Name: | Unclassified, various manual surgical<br>instruments |
| E. | Product Code: | MRW |
| F. | Device Panel: | Orthopedic, General, and Plastic Surgery |
| G. | Device Class: | Unclassified |

## Predicate Devices

Triage Medical Disposable Posterior Lumbar Stabilization (PLS) Procedure Kit) K062391

Triage Medical BONE-LOK® 4.5mm Facet Screw and BONE-LOK® FS Instrument Kit K043351.

TranS1® Facet Screws K073515

# DEVICE DESCRIPTION

The 4.5mm BONE-LOK® PLS Implant is a double-helix screw with a compressionlocking collar made of medical grade titanium alloy and is provided "STERILE". The Single use PERPOS™ PLS System contains the 4.5mm BONE-LOK® PLS Implant

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K082795

and disposable surgical instruments for use in implanting the device and is provided "STERILE". The re-usable Compression Tool is provided separately in a "NONSTERILE" condition; sterilization is by moist heat (steam autoclave) and is performed on-site.

#### INTENDED USE/INDICATIONS for USE

The 4.5mm BONE-LOK® PLS IMPLANT is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis, or failed previous fusion.

The intended use of the 4.5mm BONE-LOK® PLS Implant is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 4.5mm BONE-LOK® PLS Implant may be used to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construction as an aid to fusion. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm BONE-LOK® PLS Implant is intended for lumbar bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the 4.5mm BONE-LOK® PLS Implant.

## TECHNOLOGICAL CHARACTERISTICS and SUBSTANTIAL EQUIVALENCE

Documentation was provided to demonstrate that the modified 4.5mm BONE-LOK® PLS Implant and PERPOS™ PLS System are identical or similar to the predicate devices in technological characteristics. The 4.5mm BONE-LOK® PLS Implant and PERPOS ™ PLS System are substantially equivalent to the predicate devices in intended use, materials, design and technological characteristics.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Interventional Spine, Inc. % Ms. Carol Emerson 13700 Alton Parkway, Suite 160 Irvine, California 92618

DEC 1 2 2008

Re: K082795

Trade/Device Name: Single Use PERPOS™PLS System, 4.5 BONE-LOK® PLS Implant Regulatory Class: Unclassified Product Code: MRW Dated: September 19, 2008 Received: September 25, 2008

Dear Ms. Emerson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2 - Ms. Carol Emerson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Mulkerson

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K082795

Device Name:

Single Use PERPOS™ ™ PLS System, 4.5 BONE-LOK® PLS Implant

Indications For Use:

The 4.5mm BONE-LOK® PLS IMPLANT is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis, or failed previous fusion.

The intended use of the 4.5mm BONE-LOK® PLS Implant is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 4.5mm BONE-LOK® PLS Implant may be used to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construction as an aid to fusion. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm BONE-LOK® PLS Implant is intended for lumbar bilateral faceb fixation, with or without bone graft, at single or multiple levels from L1 to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the 4.5mm BONE-LOK® PLS Implant.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K082795 |
|---------------|---------|
|---------------|---------|

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