POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)

K071905 · Lanx, LLC · KWQ · Dec 28, 2007 · Orthopedic

Device Facts

• Record ID: K071905
• Device Name: POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
• Applicant: Lanx, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to promote fusion of the cervical spine and the thoracic spine (C1-T3) in skeletally mature patients, the LANX Posterior Cervicothoracic Spinal Fixation System (PCFS) is indicated for the following: - Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - Spondylolisthesis - Spinal Stenosis - Fracture/Dislocation - Failed previous fusion - Tumor The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Device Story

System comprises titanium alloy screws, rods, hooks, and connectors; provides supplemental stabilization to spinal segments to support fusion. Surgeon assembles components into patient-specific constructs. Used in clinical/surgical settings for stabilization following trauma or degenerative conditions. Benefits patient by providing mechanical support to promote spinal fusion. No electronic or software components.

Clinical Evidence

Bench testing only. Mechanical performance characterized per ASTM F1717 and F1798 standards.

Technological Characteristics

Titanium alloy spinal fixation system including screws, rods, hooks, and connectors. Mechanical testing performed per ASTM F1717 and F1798. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion in the cervical/thoracic spine (C1-T3) for degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, failed fusion, or tumor. Polyaxial screws restricted to T1-T3 thoracic use only.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• OASYSTTM System (K052317, K032394)
• VERTEXTM Reconstruction System (K052180, K003780)
• Mountaineer OCT Spinal System (K042508)
• Altius M-INI OCT System (K033961, K043229)
• Axon (K023675)
• Ascent (K030197)
• Solanas (K052201)

Submission Summary (Full Text)

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# K071905

## 510(k) SUMMARY

# Lanx LLC's Posterior Cervicothoracic Spinal Fixation System

## Name of Firm / Contact

Lanx, LLC 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021 303-443-7500 Contact Person: Greg Causey July 9, 2007 Date Prepared:

## Name of Device

LANX Posterior Cervicothoracic Spinal Fixation System

## Common or Usual Name

Spinal Fixation Appliance

## Product Code / Classification Name

KWP - 21 CFR 888.3050 - Spinal Interlaminal Fixation Orthosis

# Regulatory Class

Class II

#### Predicate Devices

| K052317, K032394 | OASYSTTM System | Stryker Spine |
|------------------|--------------------------------|---------------------------------------|
| K052180, K003780 | VERTEXTM Reconstruction System | Medtronic Sofamor Danek<br>USA, Inc. |
| K042508 | Mountaineer OCT Spinal System | Depuy Spine, Inc. |
| K033961, K043229 | Altius M-INI OCT System | Interpore Cross (now Biomet<br>Spine) |
| K023675 | Axon | Synthes Spine |
| K030197 | Ascent | Blackstone |
| K052201 | Solanas | Alphatec Spine |

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## Intended Use / Indications for Use

When intended to promote fusion of the cervical spine and the thoracic spine (C1-T3) in skeletally mature patients, the LANX Posterior Cervicothoracic Spinal Fixation System (PCFS) is indicated for the following:

- · Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- · Spondylolisthesis
- · Spinal Stenosis
- · Fracture/Dislocation
- · Failed previous fusion
- · Tumor

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine,

#### Device Description

The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various titanium alloy screws, rods, hooks, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.

## Performance Data

Performance testing was performed per ASTM F1717 and F1798 to characterize the LANX Posterior Cervicothoracic Spinal Fixation system .

### Substantial Equivalence

Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed Posterior Cervicothoracic Spinal fixation systems. Mechanical testing demonstrated comparable mechanical properties to the predicate devices

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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)" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle.

Public Health Service

DEC 2 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lanz, LLC % Mr. Greg Causey, Ph.D. Director, Fusion Technologies 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021

Re: K071905

Trade/Device Name: LANX Postierior Cervicothoracic Spinal Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWQ Dated: November 7, 2007 Received: November 8, 2007

Dear Dr. Causey:

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 (OS) 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 - Mr. Greg Causey, Ph.D.

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 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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millman

- 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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## Appendix 1

## Indications for Use Statement

510(k) Number (if known):

#### Device Name: LANX Posterior Cervicothoracic Spinal Fixation System

#### Indications for_Use:

When intended to promote fusion of the cervical spine and the thoracic spine (C1-T3) in skeletally mature patients, the LANX Posterior Cervicothoracic Spinal Fixation System (PCFS) is indicated for the following:

- Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- Spinal Stenosis ●
- Fracture/Dislocation .
- Failed previous fusion .
- . Tumor

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Over-The-Counter Use Prescription Use _ X AND/OR (Part 21 C.F.R. 801 Subpart D) (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buellm

and Neurologica

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510(k) Number
K071905