LIFE SPINE LUMBAR PLATE SYSTEM

K093200 · Life Spine · KWQ · Jan 19, 2010 · Orthopedic

Device Facts

• Record ID: K093200
• Device Name: LIFE SPINE LUMBAR PLATE SYSTEM
• Applicant: Life Spine
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

Device Story

Life Spine Anterior Lumbar Fixation System (Presidio) consists of plates and screws for spinal fixation; components rigidly lock to accommodate patient-specific pathology and anatomy. Used by surgeons in OR settings for thoracic, thoracolumbar, lumbar, and lumbosacral stabilization. Provides mechanical support to the spine to facilitate fusion; benefits patients by addressing instability caused by degenerative conditions, trauma, or deformity.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

System comprises plates and screws for spinal intervertebral body fixation. Materials and mechanical performance validated via biomechanical testing per ASTM standards.

Indications for Use

Indicated for patients requiring stabilization of thoracic, thoracolumbar (T1-L5), lumbar, or lumbosacral (L1-S1) spine instability due to fracture, tumor, degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities, spinal stenosis, or failed previous surgery.

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.

Submission Summary (Full Text)

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| Submitted By: | Life Spine, Inc.<br>2401 W. Hassell Road, Suite 1535<br>Hoffman Estates, IL 60169<br>Telephone: [phone]<br>Fax: [phone] | JAN 1 9 2010 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 510(k) Contact: | Charles P. Gill<br>Life Spine, Inc.<br>2401 W. Hassell Road, Suite 1535<br>Hoffman Estates, IL 60169<br>Telephone: [phone]<br>Fax: [phone] | |
| Date Prepared: | October 6, 2009 | |
| Trade Name: | Life Spine Anterior Lumbar Fixation System (Presidio) | |
| Common Name: | Spinal Fixation System | |
| Classification: | KWQ, 21 CFR 888.3060, Class II | |

## 510(k) Summary Life Spine Anterior Lumbar Fixation System (Presidio™)

#### Device Description:

The Life Spine Anterior Lumbar Fixation System (Presidio) consists of a variety of plates and screws. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.

### Intended Use of the Device:

The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

# Performance Data:

Biomechanical testing in accordance with appropriate ASTM standards was conducted to demonstrate substantial equivalence to the predicate devices.

# Substantial Equivalence:

The Life Spine Anterior Lumbar Fixation System (Presidio) was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem of a stylized bird with outstretched wings, symbolizing protection and care.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 1 9 2010

Life Spine % Mr. Charles P. Gill Director Regulatory Affairs/ Quality Assurance Manager 2401 W. Hassell Road - Suite 1535 Hoffman Estates, Illinois 60169

Re: K093200

Trade/Device Name: Life Spine Anterior Lumbar Fixation System (Presidio ") Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: January 04, 2010 Received: January 05, 2010

Dear Mr. Gill:

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. Iisting 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 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); medical device reporting (reporting of medical

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Page 2 - Mr. Charles P. Gill

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 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/ReportalProblem/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 vours.

Kailara buelum

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

510(k) Number (if known):

Device Name: Life Spine Anterior Lumbar Fixation System (Presidio™)

Indications for Use: The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

Prescription Use V (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)

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

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K093200 510(k) Number_

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| Sponsor: | Nexxt Medical, Inc.<br>10142 Brooks School Road<br>Fishers, IN 46037<br>Phone [phone]<br>Fax [phone] | JAN 1 9 2010 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Andy Elsbury, President | |
| Proposed Trade Name: | Blade™ Anterior Cervical Plate System | |
| Device Classification | Class II | |
| Classification Name: | Appliance, fixation, spinal intervertebral body | |
| Regulation: | 888.3060 | |
| Device Product Code: | KWQ | |
| Device Description: | The Blade™ Anterior Cervical Plate System consists of and screws and<br>plates in a variety of sizes. One-, two- and three-level plates are offered.<br>Screws are available in two diameters in both self-tapping and self-drilling<br>versions. The Blade™ Anterior Cervical Plate System components are<br>manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM<br>F136 or titanium (Grade 2 or 4) as described by ASTM F67. | |
| Intended Use: | The Blade™ Anterior Cervical Plate System is intended for anterior screw<br>fixation of the cervical spine. These implants have been designed to provide<br>stabilization as an adjunct to cervical fusion. Indications for the use of this<br>implant system include degenerative disc disease (defined as neck pain of<br>discogenic origin with the degeneration of the disc confirmed by history and<br>radiographic studies), spondylolisthesis, trauma (i.e., fractures or<br>dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or<br>scoliosis), tumor, pseudarthrosis or failed previous fusion.<br>WARNING: The Blade™ Anterior Cervical Plate System is not intended<br>for screw attachment or fixation to the posterior elements (pedicles) of the<br>cervical, thoracic or lumbar spine. | |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the Blade™ Anterior<br>Cervical Plate System to be substantially equivalent to previously cleared<br>devices: The substantial equivalence is based upon equivalence in basic<br>design, intended use, indications, anatomic sites and mechanical<br>performance. | |

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1. September 19.

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# 8. 510(k) Summary

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