Cure™ Anterior Cervical Plate (ACP) System

K160604 · Meditech Spine, LLC · KWQ · Jul 1, 2016 · Orthopedic

Device Facts

• Record ID: K160604
• Device Name: Cure™ Anterior Cervical Plate (ACP) System
• Applicant: Meditech Spine, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cure™ Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions.

Device Story

Cure™ Anterior Cervical Plate (ACP) System is a spinal implant for anterior screw fixation in the cervical spine (C2-C7). The system consists of titanium plates and screws of varying sizes to accommodate surgical approaches. It features a central locking mechanism to secure bone screws in place. Used by surgeons in clinical settings for temporary stabilization during cervical spinal fusion procedures. The device provides mechanical support to the spine, facilitating fusion and potentially reducing pain and instability associated with degenerative disc disease, trauma, or deformity.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including static compression bending, static tension, static torsion, dynamic compression bending, screw insertion torque, screw pullout, and screw torque to failure, performed in accordance with ASTM F1717 and ASTM F543 standards.

Technological Characteristics

Constructed from Grade 23 Titanium (Ti-6Al-4V ELI) per ASTM F136. System includes plates and screws of various dimensions. Features a central locking mechanism for screw retention. Mechanical performance validated via ASTM F1717 and ASTM F543 testing.

Indications for Use

Indicated for skeletally mature patients requiring temporary anterior spinal stabilization during cervical fusion at C2-C7 levels. Conditions include Degenerative Disc Disease, Spondylolisthesis, Trauma (fractures/dislocations), Deformity (kyphosis, lordosis, scoliosis), Pseudarthrosis, and failed previous fusions.

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

• IST Anterior Cervical Plate (K072650)
• Synthes CSLP (K926453)

Submission Summary (Full Text)

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

July 1, 2016

Meditech Spine, LLC Mr. Bruce Dunaway Chief Design Engineer 1447 Peachtree Street, North East Suite 440 Atlanta, Georgia 30309

Re: K160604

Trade/Device Name: Cure™ Anterior Cervical Plate (ACP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 16, 2016 Received: May 31, 2016

Dear Mr. Dunaway:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/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 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,

# Mark N. Melkerson -S

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K160604

Page 1 of 1

510(k) Number (if known) K160604

Device Name

Cure™ Anterior Cervical Plate (ACP) System

#### Indications for Use (Describe)

Cure™ Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
| <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## meditech si

1447 Peachtree St NE Suite 440, Atlanta GA 30309 | p [phone] | f [phone] | [e-mail]

### 510(k) Summarv

As required by section 807.92(c)

Meditech Spine, LLC is requesting marketing clearance for the Cure™ Anterior Cervical Plate (ACP) System

| A. Sponsor/Manufacturer: | Meditech Spine, LLC<br>Registration Number: 3009405289<br>Bruce Dunaway, Chief Design Engineer<br>1447 Peachtree St NE Suite 440<br>Atlanta, GA 30309<br>678-974-5287 Phone<br>404-759-2104 Fax |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Trade Name:<br>Common Name:<br>Classification Name: | Cure™ Anterior Cervical Plate (ACP) System<br>Spinal Implant<br>Spinal intervertebral body fixation orthosis (21 CFR 888.3060<br>Class II,Product Code KWQ) |
| C. Predicate Device: | K072650 (IST Anterior Cervical Plate) (Primary)<br>K926453 (Synthes CSLP) (Additional) |

#### D. Device Description:

Cure™ Anterior Cervical Plate (ACP) System is composed of plates in a wide range of sizes to coincide with the surgical approach and screws that are available in multiple lengths and diameters.

Cure™ Anterior Cervical Plate (ACP) System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

### E. Intended Use:

Cure™ Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the Disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Deformity (defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions.

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## meditech spine, IIc

1447 Peachtree St NE Suite 440, Atlanta GA 30309 | p [phone] | f [phone] | [e-mail]

- F. Technological Characteristics:
The technological characteristics of the Cure™ Anterior Cervical Plate (ACP) System is equivalent to the predicate device, except for the central locking mechanism. The central locking mechanism is provided to ensure that the bone screws remain in place.

- G. Non-clinical Testing:
Testing according to ASTM F1717 and ASTM F543 was performed on the Cure™ Anterior Cervical Plate (ACP) System to establish equivalency to the predicate device. The tests included static compression bending, static tension, static torsion, dynamic compression bending, screw insertion torque, screw pullout and screw torque to failure.

Cure™ Anterior Cervical Plate (ACP) System is equivalent in mechanical function and properties to the predicate device, establishing equivalency in safety and effectiveness.

- H. Conclusion:
The testing completed as well as a comparison of the technological characteristics has demonstrated that the Cure™ Anterior Cervical Plate (ACP) System is substantially equivalent to the predicate device.