LTD POLYAXIAL FIXATION SYSTEM

K062785 · Us Spine · KWP · Dec 26, 2006 · Orthopedic

Device Facts

• Record ID: K062785
• Device Name: LTD POLYAXIAL FIXATION SYSTEM
• Applicant: Us Spine
• Product Code: KWP · Orthopedic
• Decision Date: Dec 26, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

Device Story

LTD Polyaxial Fixation System consists of rods, screws, and connecting components; used for spinal immobilization and stabilization as an adjunct to fusion. Components are tailor-made for individual cases; rigidly locked into configurations. Used in posterior non-cervical spine; operated by surgeons in clinical/OR settings. Provides mechanical support to spinal segments to facilitate fusion. Benefits include stabilization of unstable spinal segments in patients with degenerative conditions, fractures, or tumors.

Clinical Evidence

Bench testing only. Biomechanical testing included static axial compression bending, static torsion, and dynamic axial compression bending tests. All tests met acceptance criteria.

Technological Characteristics

Materials: medical grade titanium or titanium alloy (ASTM F67, ASTM F136, ISO 5832-2/3). Polyaxial screw and rod fixation system. Mechanical assembly.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Conditions: degenerative spondylolisthesis, fracture, dislocation, spinal tumor, pseudarthrosis, degenerative disc disease, spinal stenosis. Specific constraints for pedicle screw use: L3 and below, autogenous bone graft only, severe L5-S1 spondylolisthesis (Grades 3-4).

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

• Moss Miami Pedicle Fixation System (K980447)
• Stryker Spine Xia Spine System (K984251)
• Optima Spine System (K031585)

Submission Summary (Full Text)

{0}------------------------------------------------

K662785

## 510(k) Summary

| Manufacturer: | US Spine<br>3600 FAU Blvd., Suite 101<br>Boca Raton, FL 33431 | DEC 26 2006 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitted By: | Richard Jansen, Pharm. D.<br>Silver Pine Consulting<br>13540 Guild Ave.<br>Apple Valley, MN 55124<br>Phone [phone]<br>Fax [phone]<br>[e-mail] | |
| Proprietary Name: | LTD Polyaxial Fixation System | |
| Classification Name: | Appliance, Fixation, Spinal | |
| Common/Usual Name: | Pedicle Screw Spinal System | |
| Classification: | Class II (888.3050, 888.3060, 888.3070) | |
| Product Codes: | MNH, MNI, KWP, KWQ | |
| Predicate Devices: | K980447 - Moss Miami Pedicle Fixation System<br>K984251 - Stryker Spine Xia Spine System<br>K031585 - Optima Spine System | |
| Device Description: | The LTD Polyaxial Fixation System consists of a variety of<br>shapes and sizes of rods, screws and connecting<br>components, sold with or without the surgical instrument<br>tray. These components can be rigidly locked into a variety<br>of configurations, with each construct being tailor-made for<br>the individual case. The LTD Polyaxial Fixation System<br>implant components are fabricated from medical grade<br>titanium or titanium allow described by such standards at<br>ASTM F67 or ASTM F136 for ISO 5832-2/3.<br><br>This Pre-market Notification adds 5.5mm rods and<br>associated polyaxial screws to the LTD Polyaxial System. | |
| Indications for Use: | The LTD Polyaxial Fixation System is intended to help<br>provide immobilization and stabilization of spinal segments<br>as an adjunct to fusion of the lumbar and/or sacral spine, | |

Pg 1 of 2

{1}------------------------------------------------

## K612785

When used as a pedicle screw fixation system of the noncervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

Biomechanical testing included a static axial compression Performance Data: bending test, static torsion test and dynamic axial compressing bending test. All tests met the acceptance criteria.

pg 2of2

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

US Spine % Richard Jansen, Pharm. D Silver Pine Consulting 13540 Guild Ave Apple Valley, Minnesota 55124

DEC 26 2006

Re: K062785

Trade/Device Name: LTD 5.5 Polyaxial Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, KWQ, MNI, MNH Dated: November 22, 2006 Received: November 27, 2006

Dear Dr. Jansen:

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.

{3}------------------------------------------------

Page 2 - Dr. Richard Jansen

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address <http://www.fda.gov/cdrb/industry/support/index.html>.

Sincerely yours.

Barbara Buchmu

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

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number: K062785

Device Name: LTD Polyaxial Pedicle Fixation System

Indications for Use:

The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

Prescription Use V (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchud

(Division Sign-Of Division of General, Restarative, and Neurological Devices

510(k) Number K062785