Aspida® Anterior Lumbar Plating System

K182808 · Alphatec Spine, Inc. · KWQ · Nov 9, 2018 · Orthopedic

Device Facts

• Record ID: K182808
• Device Name: Aspida® Anterior Lumbar Plating System
• Applicant: Alphatec Spine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Aspida Anterior Lumbar Plating System is a spinal fixation system consisting of non-sterile, single-use titanium alloy plates and screws; includes Class I manual instruments. Used by surgeons for anterior or anterolateral lumbar/lumbosacral (L1-S1) spine fixation. Provides temporary internal stabilization during bone graft healing or fusion mass development. System components are implanted during surgery to maintain alignment and stability; clinical benefit is stabilization of the spinal segment to facilitate fusion.

Clinical Evidence

No clinical data. Substantial equivalence determination based on nonclinical bench testing, including static compression, static torsion, and dynamic compression testing performed in accordance with ASTM F1717.

Technological Characteristics

Materials: Titanium alloy (ASTM F136). Components: Plates and screws. Energy source: None (manual instrumentation). Connectivity: None. Sterilization: Non-sterile. Design: Spinal intervertebral body fixation orthosis for L1-S1 levels.

Indications for Use

Indicated for anterior lumbar spine (L1-S1) fixation in patients with degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, failed previous fusion, spinal deformities (scoliosis, kyphosis, lordosis), or tumor. Intended for temporary fixation until fusion is achieved.

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

• Alphatec Spine Anterior Lumbar Plating System (K101255)
• Pioneer Lumbar Plate System (K090222)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a circular seal with an emblem in the center. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 9, 2018

Alphatec Spine, Inc. Ms. Ruby Zheng Regulatory Affairs Compliance Specialist 5818 El Camino Real Carlsbad, California 92008

# Re: K182808

Trade/Device Name: Aspida® Anterior Lumbar Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 2, 2018 Received: October 3, 2018

Dear Ms. Zheng:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Ronald P. Jean -S

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

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

### K182808

Device Name Aspida® Anterior Lumbar Plating System

### Indications for Use (Describe)

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

The Aspida 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

| Type of Use (Select one or both, as applicable) | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <table border="0"><tr><td><div> <span> <b> <span style="font-size:12pt"> <span style="font-family:Symbol"> <span style="color:#000000">✓</span> </span> </span> </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div></td></tr><tr><td><div> <span> <b> <span style="font-size:12pt"> <span style="font-family:Symbol"> <span style="color:#000000">□</span> </span> </span> </b> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div> <span> <b> <span style="font-size:12pt"> <span style="font-family:Symbol"> <span style="color:#000000">✓</span> </span> </span> </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <b> <span style="font-size:12pt"> <span style="font-family:Symbol"> <span style="color:#000000">□</span> </span> </span> </b> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
| <div> <span> <b> <span style="font-size:12pt"> <span style="font-family:Symbol"> <span style="color:#000000">✓</span> </span> </span> </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | | |
| <div> <span> <b> <span style="font-size:12pt"> <span style="font-family:Symbol"> <span style="color:#000000">□</span> </span> </span> </b> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Atec. The logo consists of a green square with a white letter "a" inside of it. To the right of the square is the word "tec" in white font, with a trademark symbol above the "c".

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

| I. | SUBMITTER: | Alphatec Spine, Inc.<br>5818 El Camino Real<br>Carlsbad, CA 92008<br>Phone: [phone]<br>Fax: [phone] |
|----|------------------------|-------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Ruby Zheng<br>Regulatory Affairs Compliance Specialist<br>Contact Phone: [phone] |
| | Date Summary Prepared: | November 8, 2018 |

#### II. DEVICE

| Name of Device: | Aspida® Anterior Lumbar Plating System |
|-----------------------|----------------------------------------------------------------------|
| Common or Usual Name: | Spinal Intervertebral Body Fixation Orthosis |
| Classification Name: | Appliance, Fixation, Spinal Intervertebral Body<br>(21 CFR 888.3060) |
| Regulatory Class: | Class II |
| Product Code: | KWQ |

#### III. LEGALLY MARKETED PREDICATE DEVICES

| 510(k) | Product Code | Trade Name | Manufacturer |
|-----------------------------|--------------|--------------------------------------------------|--------------------------------|
| Primary Predicate Device | | | |
| K101255 | KWQ | Alphatec Spine Anterior Lumbar<br>Plating System | Alphatec Spine |
| Additional Predicate Device | | | |
| K090222 | KWQ | Pioneer Lumbar Plate System | Pioneer Surgical<br>Technology |

#### IV. DEVICE DESCRIPTION

The Aspida 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.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for a company called "atec". The logo consists of a green square with a white stylized "a" inside of it. To the right of the square is the word "tec" in white sans-serif font. The letters are connected to each other. The background of the image is a dark blue color.

#### V. INDICATIONS FOR USE

The Aspida Anterior Lumbar Plating System is intended for use 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 Aspida 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

#### VI. TECHNOLOGICAL COMPARISON TO PREDICATES

The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.

#### VII. PERFORMANCE DATA

Nonclinical testing performed on the Aspida Anterior Lumbar Plating System supports substantial equivalence to other predicate devices. The following testing was performed:

- Static compression testing per ASTM F1717
- Static torsion testing per ASTM F1717 ●
- . Dynamic compression testing per ASTM F1717

The results demonstrate that the subject Aspida Anterior Lumbar Plating System is substantially equivalent to other predicate devices for nonclinical testing.

## Clinical Information

Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image is a logo for a company called "atec". The logo consists of a green square with rounded corners on the left side, and the word "atec" in white letters on the right side. The "a" in "atec" is stylized with a curved line that resembles the Greek letter alpha. There is a trademark symbol after the "c" in "atec".

K182808 Page 3 of 3

# VIII. CONCLUSION

Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regards to indications for use, intended use, design, technology, and performance.