CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE

K091134 · Custom Spine, Inc. · KWQ · Aug 17, 2009 · Orthopedic

Device Facts

• Record ID: K091134
• Device Name: CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE
• Applicant: Custom Spine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The REGENT 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 history and radiographic studies) Trauma (including fractures) Tumors Deformities or curvatures (including kyphosis, lordosis or scoliosis) Pseudoarthrosis Failed previous fusion Spondylolisthesis Spinal Stenosis. THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS. WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE.

Device Story

The REGENT Anterior Cervical Plate System is a spinal fixation orthosis used by surgeons to provide temporary stabilization of the anterior cervical spine (C2-T1) during fusion procedures. The system consists of titanium alloy plates and screws, available in fixed or variable configurations, designed to be implanted during surgery. The device functions as a mechanical construct to support the spine while biological fusion occurs. It is intended for use in skeletally mature patients. The surgeon selects appropriate plate levels and screw types based on the patient's anatomical needs and clinical condition. The device provides structural support to the anterior spine, potentially reducing pain and restoring stability in patients with degenerative, traumatic, or deformity-related spinal conditions.

Clinical Evidence

No clinical data. Bench testing performed per ASTM F 1717-04, "Standard Test Method For Spinal Implant Constructs in a Vertebrectomy Model," to characterize the construct.

Technological Characteristics

Implants manufactured from Titanium alloy (Ti-6Al-V, ASTM F-136/ISO 5832-3). Instruments manufactured from stainless steel. System includes multi-level plates (1, 3, 4 level) and fixed or variable screws. Anodized finish. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for skeletally mature patients requiring temporary anterior cervical spine stabilization (C2-T1) during fusion. Conditions include degenerative disc disease, trauma/fractures, tumors, deformities (kyphosis, lordosis, scoliosis), pseudoarthrosis, failed 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 Anterior Compact Plate System (K041469)
• Synthes CSLP (K030866)

Submission Summary (Full Text)

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

# 1091134

# 510(K) SUMMARY

AUG 1 7 2009

#### Name of Firm

Custom Spine, Incorporated 1140 Parsippany Blvd, Suite 201 Parsippany, NJ 07054 Phone: [phone] Fax: [phone]

## Official Correspondent

Saad Attiyah Manager of Regulatory Affairs and Quality Assurance 1140 Parsippany Blvd, Suite 201 Parsippany, NJ 07054 Phone: [phone] Fax: [phone] E-mail: [e-mail]

Establishment Number 3005129649

#### Device Name

Legally Marketed Trade Name: REGENT Anterior Cervical Plate System Common Name: Spinal Intervertebral Body Fixation Orthosis. Device Classification: Class II Regulation Number: 21 CFR 888.3060 Device Product Codes: KWQ

#### Predicate Devices

X-Spine Anterior Compact Plate System (K041469), Synthes CSLP (K030866)

### Device Description

The REGENT Anterior Cervical Plate System is composed of various cervical plates and the screws in made from a Titanium alloy (Ti-6Al-V, ASTM F-136/ISO 5832-3). The REGENT Anterior Cervical System contains multiple level plates (1 Level, 3 Level, and 4 Level) and various diameter screws that are either fixed or variable in nature. The plates and screws are anodized.

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

#### Indications for Use

The Regent Anterior Cervical Plate System is intended for 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 history and radiographic studies)
- . Trauma (including fractures)
- . Tumors
- . Deformities or curvatures (including kyphosis, lordosis or scoliosis)
- . Pseudoarthrosis
- . Failed previous fusion
- . Spondylolisthesis
- Spinal Stenosis

#### THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS

WARNING: THIS DEVICE IS NOT INTEDED FOR SCREW ATTACHEMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE

#### Materials

The Regent Anterior Cervical Plate System contains implants are manufactured from Titanium alloy (Ti-6AI-V, ASTM F-136/ISO 5832-3). The system contains instrument and non-implantable devices manufactured from stainless steel.

#### Performance Data

Performance data per ASTM F 1717-04, " Standard Test Method For Spinal Implant Constructs in a Vertebrectomy Model", were submitted to characterize the subject Regent Anterior Cervical Plate System

#### Substantial Equivalence Statement

The Custom Spine Regent Anterior Cervical Plate (ACP) System is equivalent to the previously cleared systems, as they utilize the same principle of operation, and has identical indications for use as the predicates, and materials.

Animal Testing Not Applicable

Bench Testing The data are included in the submission under "Bench Testing", Section 19.

Clinical Testing Not Applicable

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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

## AUG 1 7 2009

Custom Spine Inc. % Mr. Saad Attiyah Manager of Regulatory Affairs and Quality Assurance 1140 Parsippany Boulevard, Suite 201 Parsippany, New Jersey 07054

Re: K091134

Trade/Device Name: Custom Spine Regent Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: August 10, 2009 Received: August 10, 2009

Dear Mr. Attiyah:

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.

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

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

#### Page 2 - Mr. Saad Attiyah

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.

Balbare Bavehud
fix

Mark N. Melkerso Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# INDICATIONS FOR USE STATEMENT

The REGENT 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 history and radiographic studies)
- Trauma (including fractures) �
- ◆ Tumors
- Deformities or curvatures (including kyphosis, lordosis or scoliosis) �
- � Pseudoarthrosis
- Failed previous fusion
- Spondylolisthesis ●
- Spinal Stenosis .

THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS.

WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 C.F.R. 801 Subpart D)

(21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

E
(EXT for MX,N)

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

510(k) Number K091134