LANX DEFORMITY SYSTEM

K071633 · Lanx, LLC · KWP · Aug 15, 2007 · Orthopedic

Device Facts

• Record ID: K071633
• Device Name: LANX DEFORMITY SYSTEM
• Applicant: Lanx, LLC
• Product Code: KWP · Orthopedic
• Decision Date: Aug 15, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lanx Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Device Story

Lanx Deformity System is a posterior pedicle fixation system; line extension to Lanx Spinal Fixation System. Components include polyaxial screws, rods, hooks, and connectors. System provides immobilization and stabilization of spinal segments as an adjunct to fusion. Used in thoracic, lumbar, and sacral spine procedures. Surgeons implant components to treat instabilities or deformities. Mechanical testing confirms properties comparable to predicate. No software or algorithmic components.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Posterior pedicle fixation system. Components: polyaxial screws, rods, hooks, connectors. Materials: alloyed titanium and unalloyed titanium. Mechanical properties verified via bench testing. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization and stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions including severe spondylolisthesis (grades 3-4, L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudarthrosis.

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

• Lanx Spinal Fixation System (K043484)

Submission Summary (Full Text)

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K071633

#### 510(k) SUMMARY

#### Lanx Deformity System

AUG 1 5 2007

| Submitter Information | |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Name and Address of Sponsor of the 510(k) Submission: | Lanx, LLC<br>390 Interlocken Crescent, Suite 890<br>Broomfield, CO 80021 |
| Contact Person: | Ryan Fredricey |
| Date of Summary Preparation: | June 13, 2007 |
| Device Identification | |
| Proprietary Name: | Lanx Spinal Fixation System |
| Common Name: | Spinal Fixation System |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis<br>21 CFR §888.3050<br><br>Pedicle Screw Spinal System<br>21 CFR §888.3070 |

Predicate Device Information

K043484 Lanx Spinal Fixation System

#### Predicate Device Identification

The Lanx Spinal Fixation System is a posterior attachment pedicle fixation system. The system consists of a series of polyaxial screws, rods, cross connectors and interlocking mechanisms. The components are manufactured from alloyed titanium.

## Description of Device Modification

This submission is intended to address a line extension to the Lanx Spinal Fixation System. The line extension includes additional pedicle screw sizes/configurations, hooks, connectors and the introduction of unalloyed titanium rods.

#### Intended Use

The Lanx Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis

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(grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

## Statement of Technological Comparison

The Lanx Deformity System has the same intended use and similar indications, principles of operation, and technological characteristics as the Lanx Spinal Fixation System. The minor differences in the line item extensions items do not raise any new questions of safety or effectiveness. Mechanical testing also demonstrated comparable mechanical properties to the predicate device.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2007

Lanx, LLC Janice M. Hogan % Hogan and Hartson, LLP 1835 Market Street, 28th Floor Philadelphia, PA 19102

K071633 Re:

Trade/Device Name: Lanx Deformity System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNI Dated: July 19, 2007 Received: July 19, 2007

Dear Ms. Hogan:

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 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees mat have been 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. Janice M. Hogan

This letter will allow you to begin marketing your device as described in your Section 510(k) 1 mm let notification. The FDA finding of substantial equivalence of your device to a legally prematted 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 at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Noubara Buelup

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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## Indications for Use Statement

510(k) Number (if known):_KO71633

Device Name: Lanx Spinal Fixation System

Indications for Use:

The Lanx Spinal Fixation System is intended to provide immobilization and I the Hans Opinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with (); ative evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Prescription Use _ X (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General. Restorative. and Neurological Devices

**510(k) Number** K071633
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