ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM

K101255 · Alphatec Spine, Inc. · KWQ · Jul 21, 2010 · Orthopedic

Device Facts

• Record ID: K101255
• Device Name: ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
• Applicant: Alphatec Spine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alphatec Spine Anterior Lumbar Plating System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Alphatec Spine Anterior Lumbar Plating System is intended for anterior lumbar spine (L1-S1) fixation for the following indications: 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies) 2. Pseudoarthrosis 3. Spondylolysis 4. Spondylolisthesis 5. Trauma (i.e., fracture or dislocation) 6. Spinal stenosis 7. Unsuccessful previous fusion surgery 8. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) 9. Tumor The Alphatec Spine Anterior Lumbar Plating System is intended to be used with autograft and/or allograft as an adjunct to fusion.

Device Story

Spinal fixation system consisting of non-sterile, single-use titanium alloy plates and screws; used for temporary internal stabilization of lumbar/lumbosacral spine (L1-S1). Implanted by surgeons via anterior, lateral, or anterolateral surgical approaches. Provides supplemental fixation during bone graft healing or fusion mass development. Output is mechanical stabilization of vertebral bodies. Benefits patient by maintaining alignment and supporting fusion in cases of degenerative disease, trauma, or deformity.

Clinical Evidence

Bench testing only. Mechanical static compression, torsion, and dynamic testing performed per recognized consensus standards and FDA guidance for spinal systems. Results demonstrate performance characteristics satisfy requirements for anterolateral lumbar fixation and support substantial equivalence.

Technological Characteristics

Titanium alloy (ASTM F136) plates and screws. Manual surgical instruments (Class I). Designed for anterior/anterolateral lumbar/lumbosacral fixation. Non-sterile, single-use implants.

Indications for Use

Indicated for patients requiring anterior lumbar spine (L1-S1) fixation for degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, failed previous fusion, deformities (scoliosis, kyphosis, lordosis), or tumor. Used with autograft/allograft as fusion adjunct.

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

• Anterior Lumbar Plate System (K091044)
• Unity Anterior Lumbar Plate Fixation System (K043548)
• Unity LX Anterolateral Lumbar Plate Fixation System (K061229)

Submission Summary (Full Text)

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K101255 Page 1/2

Image /page/0/Picture/1 description: The image shows the logo for Alphatec Spine. The logo consists of the Greek letter alpha above the words "Alphatec Spine". The word "Spine" is in a cursive font.

510(k) Summary Alphatec Spine, Inc. Alphatec Spine Anterior Lumbar Plating System

#### 510(k) SUMMARY May 2010

| Submitter: | Alphatec Spine, Inc.<br>5818 El Camino Real<br>Carlsbad, CA 92008<br>Direct: [phone]<br>Fax: [phone] | JUL 21 2010 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------|-------------|
| Official Contact: | Karla Schaffner, Regulatory Affairs Submissions Specialist | |
| Trade/Model Name: | Alphatec Spine Anterior Lumbar Plating System | |
| Common Name: | Spinal Intervertebral Body Fixation Orthosis | |
| Classification Regulation: | KWQ - 888.3060 - Appliance, Fixation, Spinal Intervertebral<br>Body | |

## Substantial Equivalence:

C

The Alphatec Spine Anterior Lumbar Plating System is substantially equivalent in intended use and function to the following predicate devices:

| Company | System | Clearance |
|--------------------|-----------------------------------------------------|-----------|
| Spinal USA | Anterior Lumbar Plate System | K091044 |
| Blackstone Medical | Unity Anterior Lumbar Plate Fixation System | K043548 |
| Blackstone Medical | Unity LX Anterolateral Lumbar Plate Fixation System | K061229 |

#### Device Description:

The Alphatec Spine Anterior Lumbar Plating System is a spinal fixation system that consists of a variety of non-sterile, single-use plates and screws. All implants are manufactured from titanium alloy conforming to ASTM F136. The system also contains Class I manual instruments. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.

#### Intended Use

The Alphatec Spine Anterior Lumbar Plating System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved.

The Alphatec Spine Anterior Lumbar Plating System is intended for anterior lumbar spine (L1-S1) fixation for the following indications:

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101255 Page 2/2

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**Alphatec Spring**

# 510(k) Summary Alphatec Spine, Inc. Alphatec Spine Anterior Lumbar Plating System

- 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
- Pseudoarthrosis 2.
- 3. Spondylolysis
- 4. Spondylolisthesis
- 5. Trauma (i.e., fracture or dislocation)
- 6. Spinal stenosis
- 7. Unsuccessful previous fusion surgery
- 8. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- 9. Tumor

The Alphatec Spine Anterior Lumbar Plating System is intended to be used with autograft and/or allograft as an adjunct to fusion.

### Technological Characteristics Comparison:

The Alphatec Spine Anterior Lumbar Plating System is equivalent to the referenced device in that it is intended to be used to provide temporary internal lumbar/lumbosacral spine fixation and stabilization during bone graft healing and/or fusion mass development. It is similar in terms of general design, intended use, and technological characteristics to the predicate device.

Material composition is identical to numerous other Alphatec Spine products that have been cleared via the 510(k) process.

## Nonclinical Performance Data:

Mechanical static compression and torsion and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. Performance testing was performed per the recognized consensus standards and per the guidance document. Spinal System 510(k)s - Guidance for Industry and FDA Staff. This testing clearly demonstrated that the performance characteristics satisfy the requirements of anterolateral lumbar fixation. As a results of this testing have demonstrated that the Alphatec Spine Anterior Lumbar Plating System is substantially equivalent to the Spinal USA 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 circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an image of an eagle with its wings spread, with three lines representing the feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Alphatec Spine, Inc. % Ms. Karla Schaffner Regulatory Affairs Submission Specialist 5818 El Camino Real Carlsbad, California 92008

JUL 21 2010

Re: K101255

Trade/Device Name: Alphatec Spine Anterior Lumbar Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: K WQ Dated: May 03, 2010 Received: May 04, 2010

Dear Ms. Schaffner:

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. 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 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

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Page 2 - Ms. Karla Schaffner

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQtfices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Alphatec Spine Anterior Lumbar Plating System

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# Section 4 Indications for Use Statement

510(k) Number (if known): TBD

< 01755

Device Name: Alphatec Spine Anterior Lumbar Plating System

#### Indications for Use:

The Alphatec Spine Anterior Lumbar Plating System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved.

The Alphatec Spine Anterior Lumbar Plating System is intended for anterior lumbar spine (LJ-S1) fixation for the following indications:

- 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
- Pseudoarthrosis 2.
- Spondylolysis 3.
- 4. Spondylolisthesis
- 5. Trauma (i.e., fracture or dislocation) .
- 6. Spinal stenosis
- 7. Unsuccessful previous fusion surgery
- 8. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- 9. Tumor

.

The Alphatec Spine Anterior Lumbar Plating System is intended to be used with autograft and/or allograft as an adjunct to fusion.

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|---|
|------------------------------------------|---|

OR

Over-The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

KIDIZES 510(k) Number.

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