NUVASIVE DECADE LATERAL PLATE SYSTEM

K130868 · Nuvasive, Inc. · KWQ · Aug 29, 2013 · Orthopedic

Device Facts

• Record ID: K130868
• Device Name: NUVASIVE DECADE LATERAL PLATE SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive Decade Lateral Plate System is indicated for use via a 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), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Device Story

Decade Lateral Plate System is an anterior/anterolateral spinal fixation system; used for thoracic, lumbar, and sacral spine (T1-S1) stabilization. Components include plates and various bolts (large, threaded small, impactable small). Manufactured from titanium alloy (Ti-6Al-4V ELI). Used by surgeons in clinical settings to address spinal instability resulting from trauma, deformity, or degeneration. System provides mechanical fixation to support spinal fusion; implants selected based on patient anatomy and pathology. Device is purely mechanical; no software or electronic components.

Clinical Evidence

Bench testing only. Performed static and dynamic compression, static torsion, static tension, static separation, and nominal/angled screw push-out testing per ASTM F1717. Included cadaveric dynamic torsional physiological testing with micro-CT analysis and CAD dimensional analysis.

Technological Characteristics

Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 or ISO 5832-3. Mechanical spinal intervertebral body fixation orthosis. Includes plates and bolts. No software, electronics, or energy sources.

Indications for Use

Indicated for patients requiring thoracic, thoracolumbar (T1-L5), or lumbosacral (L1-S1) spine stabilization due to fracture, tumor, degenerative disc disease, scoliosis, kyphosis, lordosis, 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.

Predicate Devices

• NuVasive® Sage Lateral Plate System (K121815)
• NuVasive® Halo II Anterior Lumbar Plate System (K111866)

Submission Summary (Full Text)

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# 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

#### A. Submitted by:

Cynthia Adams Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone] Fax: [phone]

AUG 2 9 2013

Date Prepared: August 28, 2013

# B. Device Name

| Trade or Proprietary Name: | Decade Lateral Plate System |
|----------------------------|----------------------------------------------|
| Common or Usual Name: | Spinal Implants |
| Classification Name: | Spinal intervertebral body fixation orthosis |

| Device Class: | Class II |
|-----------------|-------------------|
| Classification: | 21 CFR § 888.3060 |
| Product Code: | KWQ |

# C. Predicate Devices

The subject Decade Lateral Plate System is substantially equivalent to the predicate device, NuVasive® Sage Lateral Plate System (K121815) and NuVasive® Halo II Anterior Lumbar Plate System (K111866).

# D. Device Description

The NuVasive Decade Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The Decade Lateral Plate System includes plates, large bolts, threaded small bolts, and impactable small bolts manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 or ISO 5832-3, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject of this 510(k) premarket notification is for the addition of the impactable small bolt.

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#### E. Intended Use

The NuVasive Decade Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (TI-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), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

#### F. Technological Characteristics

As was established in this submission, the subject Decade Lateral Plate System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, intended use, material composition, and function.

# G. Performance Data

Nonclinical testing was performed to demonstrate that the subject Decade Lateral Plate System is substantially equivalent to other predicate devices. The following testing and analysis was performed:

- Static and dynamic compression testing per ASTM F1717 .
- . Static torsion testing per ASTM F1717
- . Cadaveric dynamic torsional physiological testing with analysis of micro-CT scans
- Static tension testing per ASTM F1717 .
- Static separation testing .
- Nominal and angled screw push-out testing .
- . CAD dimensional analysis

The results demonstrate that the subject Decade Lateral Plate System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate devices.

# H. Conclusions

Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject Decade Lateral Plate System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W(066-G60 Silver Spring, MD 20993-0002

August 29, 2013

NuVasive. Incorporated Ms. Cynthia Adams Regulatory Affairs Associate 7475 Lusk Boulevard San Diego. California 92121

Re: K130868

Trade/Device Name: NuVasive® Decade Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 2. 2013 Received: August 5, 2013

Dear Ms. Adams:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.

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 four of alley 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Cynthia Adams

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

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For

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

Enclosure

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# Indications for Use

510(k) Number (if known):_ K130868

Device Name: _ NuVasive® Decade Lateral Plate System

Indications For Use:

The NuVasive Decade Lateral Plate System is indicated for use via a 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), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________ (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Anton E. Dmitriev, PhD Division of Orthopedic Devices