TRANSOM ANTERIOR CERVICAL PLATE

K142060 · Neurostructures, Inc. · KWQ · Nov 18, 2014 · Orthopedic

Device Facts

• Record ID: K142060
• Device Name: TRANSOM ANTERIOR CERVICAL PLATE
• Applicant: Neurostructures, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Transom™ is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

Transom™ Cervical Plate System; spinal intervertebral body fixation orthosis. System comprises titanium alloy bone plates and screws; locking pins preassembled to plates prevent screw back-out. Used by surgeons in clinical settings for anterior cervical fixation (C2-T1). Implantation facilitated by associated instruments. Provides structural support to stabilize cervical spine segments; aids fusion process. Benefits patients by addressing instability caused by trauma, degeneration, or deformity.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance evaluated via static axial compression bending, static torsion, and dynamic axial compression bending fatigue testing per modified ASTM F1717-13 standards.

Technological Characteristics

Titanium alloy (ASTM F136). Spinal intervertebral body fixation orthosis. Includes bone plates with preassembled locking pins and bone screws. Mechanical fixation principle. Sterilization method not specified.

Indications for Use

Indicated for anterior cervical fixation (C2-T1) in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

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

• Tempus™ Cervical Plate System (K131374)
• Tempus™ Cervical Plate System (K120515)
• Anterior Cervical Plating System (K974885)
• Anterior Cervical Plating System (K012184)
• Anterior Cervical Plating System (K030595)
• Anterior Cervical Plating System (K050892)
• Anterior Cervical Plating System (K100614)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.

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

November 18, 2014

Neurostructures, Incorporated % Ms. Meredith Mav Senior Manager Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K142060

Trade/Device Name: Transom™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 13, 2014 Received: October 20, 2014

Dear Ms. May:

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 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. Meredith May

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours. Lori A. Wiggins -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | Expiration Date: December 31, 2013 |
| Indications for Use | See PRA Statement on last page. |
| 510(k) Number (if known) | K142060 |
| Device Name | Transom™ Cervical Plate System |
| Indications for Use (Describe) | The Transom™ is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. |
| Type of Use (Select one or both, as applicable) | <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
| PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| FOR FDA USE ONLY | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| FORM FDA 3881 (9/13) | PSC Publishing Services [phone] EF |

Neurostructures, Inc. Transom™ Cervical Plate System

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# 510(K) SUMMARY

| Submitter's Name: | Neurostructures, Inc. |
|----------------------------|----------------------------------------------------------------|
| Submitter's Address: | 16 Technology Dr. Suite 165<br>Irvine, CA 92618 |
| Submitter's Telephone: | 800.352.6103 |
| Contact Person: | Meredith L. May, MS<br>Empirical Testing Corp.<br>719.337.7579 |
| Date Summary was Prepared: | 17-Oct-2014 |
| Trade or Proprietary Name: | Transom™ Cervical Plate System |
| Common or Usual Name: | Spinal intervertebral body fixation orthosis |
| Classification: | Class II per 21 CFR §888.3060 Device Classification |
| Product Code: | KWQ |
| Classification Panel: | Orthopedic |

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Transom™ Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Transom™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. Associated instruments are available to facilitate the implantation of the device. The Transom™ Cervical Plate System implant components are made from titanium alloy such as described by ASTM F136.

### INDICATIONS FOR USE

The Transom™ is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The indications for use for the Transom™ is the same as the Tempus™ Cervical Plate System (K120515, K131374).

### TECHNOLOGICAL CHARACTERISTICS

Transom™ Cervical Plate System is made from titanium alloy that conforms to ASTM F136. Titanium alloy has a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise

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any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

- . Indications for Use
- Materials of manufacture ●
- Sterilization method ●
- Structural support mechanism .

| 510k Number | Trade or Proprietary or Model Name | Manufacturer |
|------------------------------------------------|------------------------------------------------------|-----------------------|
| K131374 | Tempus™ Cervical Plate System<br>(Primary Predicate) | Neurostructures, Inc. |
| K120515 | Tempus™ Cervical Plate System | Neurostructures, Inc. |
| K974885, K012184,<br>K030595, K050892, K100614 | Anterior Cervical Plating System | Orthofix |

#### Table 5-1 Predicate Devices

## PERFORMANCE DATA

The Transom™ has been tested in the following test modes:

- Static axial compression bending per modified ASTM F1717-13 ●
- Static torsion per modified ASTM F1717-13 ●
- Dynamic axial compression bending fatigue per modified ASTM F1717-13 .

The results of this non-clinical testing show that the strength of the Transom™ is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

### CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Transom™ Cervical Plate System is substantially equivalent to the predicate device.