DIAMOND ANTERIOR CERVICAL PLATE SYSTEM

K100265 · Amendia, Inc. · KWQ · May 13, 2010 · Orthopedic

Device Facts

• Record ID: K100265
• Device Name: DIAMOND ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Amendia, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: May 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Diamond Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: - Degenerative Disc Disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies) - Trauma (including fractures) . - Tumors . - Deformities or curvatures (including kyphosis, lordosis, or scoliosis) ● - Pseudarthrosis . - . Failed previous fusion - . Spondylolisthesis - . Spinal Stenosis. Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine

Device Story

Diamond Anterior Cervical Plate System; orthopedic implant for anterior cervical spine stabilization. System comprises titanium alloy and Nitinol plates and screws; various lengths/diameters to accommodate patient anatomy and multilevel fusions. Used by surgeons in clinical settings to provide temporary stabilization during fusion development. Device provides mechanical support to spine; prevents movement during healing. Benefits patient by facilitating fusion in cases of degenerative disease, trauma, or deformity. Surgeon selects appropriate plate/screw configuration based on radiographic studies and patient history.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM 1717, including static compression bending, static torsion, static tension bending, and dynamic compression bending. No clinical data provided.

Technological Characteristics

Materials: Medical grade titanium alloy and Nitinol. Dimensions: Plates 18mm wide, 2.5mm thick; lengths 22mm-92mm. Screws 12mm-18mm length, 4.0mm-4.3mm diameter. Mechanical testing per ASTM 1717. Non-software device.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization (C2-T1) during fusion. Conditions include degenerative disc disease, trauma (fractures), tumors, deformities (kyphosis, lordosis, scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. Contraindicated for posterior element (pedicle) fixation.

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

• X-Spine ACP (K041469)
• Synthes CSLP (K000536)
• Medtronic Orion Anterior Cervical Plate System (K042499)

Submission Summary (Full Text)

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## 510(k) Summary according to 807.92(c)

MAY 1 3 2010

| Date: | April 9, 2010 |
|-----------------|----------------------------------------|
| Contact: | Tim Lusby |
| | Amendia™, LLC |
| | 1155 Allgood Road, Suite 6 |
| | Marietta, GA 30062 |
| | 770-874-0935 |
| Trade Name: | Diamond Anterior Cervical Plate System |
| Product Class: | Class II |
| Classification: | 888.3060 |
| Product Codes: | KWQ |
| Panel Code: | 87 Orthopedics |

Indications for Use: The Diamond Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

- Degenerative Disc Disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies)
- Trauma (including fractures) .
- Tumors .
- Deformities or curvatures (including kyphosis, lordosis, or scoliosis) ●
- Pseudarthrosis .
- . Failed previous fusion
- . Spondylolisthesis
- . Spinal Stenosis.

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine

Device Description: The Diamond Anterior Cervical Plate System is made of a medical grade titanium alloy and Nitinol, and consists of plates and screws of various lengths to accommodate single or multilevel fusions and variations in patients' anatomy. One level plates range from 22mm to 34mm. Two level plates range from 36mm. Three level plates range from 53mm to 77mm. Four level plates range from 68mm to 92mm. All plates are 18mm wide and have an average thickness of 2.5mm. The screws range in sizes from 12 mm to 18 mm and come in diameters of 4.0mm and 4.3mm.

Predicate Device(s): Predicate devices previously cleared by FDA include the X-Spine ACP (K041469), the Synthes CSLP (K000536) and the Medtronic Orion Anterior Cervical Plate System K042499).

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Performance Testing: The Diamond Anterior Cervical Plate System was mechanically tested using ASTM 1717. Tests included were: Static Compression Bending, Static Torsion, Static Tension Bending, and Dynamic Compression Bending. The pre-clinical testing performed indicated that the Diamond Anterior Cervical Plate is substantially equivalent to the predicate devices and is adequate for the intended use.

Comparison with Predicate: The Diamond Anterior Cervical Plate System and Medtronic Orion Anterior Cervical Plating System are both composed of Titanium Alloy and Nitinol. Synthes Spine CSLP and X-Spine ACT system are both composed of Titanium Alloy. The dimensions of Synthes Spine CSLP variable plate is 18mm wide and 2.5mm thick which is roughly equivalent to the Diamond Anterior Cervical Plate which is 18mm wide and has an average thickness of 2.5mm. The Diamond Anterior Cervical Plate System is also provided in the same lengths as the X-Spine ACT system.

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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 consists of a stylized depiction of an eagle or bird-like figure with three wing-like strokes. The bird is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

## MAY 1 3 2010

Amendia™, LLC % Mr. Tim Lusby 1155 Allgood Road, Suite 6 Marietta, Georgia 30062

Re: K100265

Trade/Device Name: Diamond Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: April 09, 2010 Received: April 12, 2010

Dear Mr. Lusby:

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

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Page 2 - Mr. Tim Lusby

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/CDRHOffices/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 vours.

Harbare Brielm

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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## 3. Statement of Indications for Use

## 510(k) Number (if known): K100265

Indications for Use:

The Diamond Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

- Degenerative Disc Disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies)
- Trauma (including fractures) .
- Tumors .
- Deformities or curvatures (including kyphosis, lordosis, or scoliosis) ●
- . Pseudarthrosis
- Failed previous fusion
- . Spondylolisthesis
- Spinal Stenosis. .

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine

Prescription Use デ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________