LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM

K092656 · Lanx, Inc. · KWP · Nov 24, 2009 · Orthopedic

Device Facts

• Record ID: K092656
• Device Name: LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
• Applicant: Lanx, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Nov 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System 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 - Trauma/Fracture/Dislocation - Atlanto-Axial Fracture with Instability . - . Occipito-Cervical Dislocation - Failed Previous Fusion . - . Tumor The use of occipital bone screws is limited to placement in the occiput only. The use of polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Device Story

System consists of titanium alloy screws, hooks, plates, rods, and connectors; used to build constructs for supplemental spinal stabilization and fusion. Surgeon-assembled in various configurations to meet patient-specific needs. Used in clinical settings for occipito-cervico-thoracic fixation. Provides mechanical support to spinal segments; facilitates fusion. Benefits patients by stabilizing unstable spinal segments.

Clinical Evidence

Bench testing only. Engineering analysis and mechanical performance testing conducted to characterize device performance and demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Titanium alloy components including screws, hooks, plates, rods, and connectors. Modular system for construct assembly. Mechanical stabilization principle. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring fusion of the occipito-cervico-thoracic spine (occiput-T3) for degenerative disc disease, spondylolisthesis, spinal stenosis, trauma/fracture/dislocation, atlanto-axial fracture with instability, occipito-cervical dislocation, failed previous fusion, or tumor. Contraindicated for polyaxial screw placement in the cervical spine.

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 PCFS (K071905)
• Ascent PCS (K030197)
• Summit/Mountaineer OCT (K042508)

Submission Summary (Full Text)

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# 1092656

## NUY 3 4 2009

#### 510(k) SUMMARY

#### Lanx Posterior Cervicothoracic Spinal Fixation System

#### Submitter Information

| Name and Address: | Lanx, Inc. | |
|-------------------|-------------------------------------|--|
| | 390 Interlocken Crescent, Suite 890 | |
| | Broomfield, CO 80021 | |
| Contact Person: | Andrew Lamborne | |
| Date Prepared: | August 26, 2009 | |

#### Device Identification

| Proprietary Name: | Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) |
|-------------------|---------------------------------------------------------------|
| Common Name: | Spinal Fixation System |
| Classification: | MNI - 21 CFR 888.3070 - Pedicle Screw Spinal System |
| | KWP - 21 CFR 888.3050 - Spinal Interlaminal Fixation Orthosis |

### Predicate Device Information

| K071905 | Lanx PCFS | Lanx, Inc. |
|---------|------------------------|--------------------------|
| K030197 | Ascent PCS | Blackstone Medical, Inc. |
| K042508 | Summit/Mountaineer OCT | Depuy Spine, Inc. |

#### Intended Use / Indications for Use

When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:

- o 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
- � Trauma/Fracture/Dislocation
- Atlanto-Axial Fracture with Instability .
- . Occipito-Cervical Dislocation
- Failed Previous Fusion .
- . Tumor

The use of occipital bone screws is limited to placement in the occiput only.

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

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#### Technological Characteristics

The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various titanium alloy screws, hooks, plates, rods, 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 and engineering analysis was conducted to characterize the performance of the Lanx Posterior Cervicothoracic Spinal Fixation System. The device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices.

#### Substantial Equivalence

The Lanx Posterior Cervicothoracic Spinal Fixation System has the same or similar intended use, indications, technological characteristics, and principles of operation as the predicate systems. Mechanical testing also demonstrated comparable mechanical properties to the predicate devices. Thus, the Lanx Posterior Cervicothoracic Spinal Fixation System is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it is depicted as a staff with two snakes coiled around it and wings at the top.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Lanx, Inc % Mr. Andrew Lamborne 390 Interlocken Crescent, Suite 890 Broomfield, Colorado 80021

NOV 2 4 2009

Re: K092656

Trade Name: Lanx Posterior Cervicothoracic Spinal Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis

- Regulatory Class: Class II Product Code: KWP, MNI
- Dated: August 26, 2009 Received: August 28, 2009

Dear Mr. Lambome:

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 (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 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 mav 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please

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go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jonetu Jr

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

:

Enclosure

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#### Indications for Use Statement

KO92656

Device Name: Lanx Posterior Cervicothoracic Spinal Fixation System

Indications for Use:

510(k) Number (if known):

When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System 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 .
- Trauma/Fracture/Dislocation .
- Atlanto-Axial Fracture with Instability �
- Occipito-Cervical Dislocation ●
- . Failed Previous Fusion
- . Tumor

The use of occipital bone screws is limited to placement in the occiput only.

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.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | |
|------------------------|--|
| (21 CFR 801 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number k092656

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