KATIA SYSTEM

K131512 · Shanghai Sanyou Medical Co, Ltd. · KWQ · Aug 7, 2013 · Orthopedic

Device Facts

• Record ID: K131512
• Device Name: KATIA SYSTEM
• Applicant: Shanghai Sanyou Medical Co, Ltd.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Katia System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fixation of the cervical spine (C2 – T1). The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (i.e. fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions, and/or 8) spinal stenosis.

Device Story

Katia System comprises titanium alloy bone plates, screws, and associated surgical instruments; used for anterior interbody screw fixation of cervical spine (C2-T1). Device provides temporary stabilization during cervical fusion development. Operated by surgeons in clinical/OR settings via anterior approach. Fixation achieved by inserting bone screws into vertebral bodies. Benefits include structural support for spinal fusion in patients with degenerative, traumatic, or neoplastic conditions. No software or algorithmic components involved.

Clinical Evidence

Bench testing only. Testing conducted in accordance with ASTM F1717-12 and FDA Guidance for Industry and FDA Staff: Spinal System 510(k)s.

Technological Characteristics

Materials: Titanium alloy. Components: Bone plates, screws, and instruments. Principle: Mechanical fixation via anterior screw insertion. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for skeletally mature patients requiring temporary anterior cervical spine (C2-T1) stabilization during fusion. Conditions: degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, failed previous fusions, and spinal stenosis.

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

• Medtronic ATLANTIS® Anterior Cervical Plate System (K081038)
• Genesys Spine Anterior Cervical Plate System (K111132)
• Synthes Anterior Cervical Locking Plate (ACLP System) (K031276)
• Synthes Small Stature Anterior Cervical Vertebrae Plate System (K971883)

Submission Summary (Full Text)

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

7 2013

| | 510(k) Summary<br>KATIA SYSTEM<br>July 22, 2013 | AUG |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Company: | Manufacturing Facility and Headquarters:<br>Shanghai Sanyou Medical Co, LTD<br>1988 Jiatang Road<br>Jiading District, Shanghai, 201807, China | |
| | Manufacturing Facility:<br>Shanghai Sanyou Medical Co, LTD<br>Rm 101/102/106/107<br>356 Renqing Rd, Building 3-1F,<br>Pudong New District, Shanghai 201201, China | |
| Establishment<br>Registration: | Registration applied; Number not assigned | |
| Primary Contact: | Kimberly Strohkirch<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] | |
| Company Contact: | David Fan, VP, Marketing<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] | |
| Trade Name: | Katia System | |
| Common Name: | Appliance, Fixation, Spinal Intervertebral Body | |
| Classification: | Class II | |
| Regulation Number: | 21 CFR 888.3060 (Spinal intervertebral body fixation orthosis) | |
| Panel: | 87- Orthopedic | |
| Product Code: | KWO | |

.

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

### Device Description:

The Katia System includes implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical fusion. The Katia system consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The components are made from titanium alloy.

## Indications for Use:

The Katia System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fixation of the cervical spine (C2 – T1). The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (i.e. fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions, and/or 8) spinal stenosis.

## Substantial Equivalence:

K081038 - Medtronic ATLANTIS® Anterior Cervical Plate System K111132 - Genesys Spine Anterior Cervical Plate System K031276 - Synthes Anterior Cervical Locking Plate (ACLP System) K971883 – Synthes Small Stature Anterior Cervical Vertebrae Plate System

### Performance Testing:

Testing was completed according to ASTM F1717-12 and Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004.

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

Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

August 7, 2013

Shanghai Sanyou Medical Co, Ltd % Memphis Regulatory Consulting Ms. Kimberly Strohkirch 3416 Roxee Run Cove Bartlett, Tennessee 38133

Re: K131512

Trade/Device Name: Katia System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 19, 2013 Received: June 20, 2013

Dear Ms. Strohkirch:

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

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

Page 2 - Ms. Kimberly Strohkirch

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Erin I. Keith

For

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

Enclosure

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

Traditional 510(k)

# Indications for Use Statement

510(k) Number (if known): K131512

Katia System Device Name:

Indications for Use:

The Katia System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fixation of the cervical spine (C2 – T1). The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (i.e. fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions, and/or 8) spinal stenosis.

| Prescription Use X<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(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

Anton E. Dmitriev, PhD Division of Orthopedic Devices

CONFIDENTIAL