GOLDEN GATE ANTERIOR PLATE SYSTEM

K101353 · Ulrich GmbH & Co. KG · KWQ · Feb 4, 2011 · Orthopedic

Device Facts

• Record ID: K101353
• Device Name: GOLDEN GATE ANTERIOR PLATE SYSTEM
• Applicant: Ulrich GmbH & Co. KG
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The golden gate™ anterior plate system is intended to provide stabilization during the development of a spinal fusion. The golden gate™ System is indicated for use in the anterior/anterolateral thoracolumbar spine (T1-L5) for the treatment of: DDD (back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), Spondylolisthesis, Spondylolysis, Fracture (including dislocation or subluxation), Spinal stenosis, Deformities (i.e., scoliosis, kyphosis, lordosis), Tumor, Pseudarthrosis, Revision of previous surgery.

Device Story

The golden gate™ System is an anterior thoracolumbar plate system used for surgical stabilization and fixation of the spine to facilitate fusion. The system consists of titanium alloy plates, screws, and connectors (hex nuts and inlays) available in various sizes to accommodate patient anatomy. It is used by surgeons in an operating room setting. The device provides mechanical stabilization to the spinal column, creating an environment conducive to bone fusion. Clinical benefit is derived from the stabilization of the affected spinal segments, addressing conditions such as fractures, deformities, and degenerative disc disease.

Clinical Evidence

Bench testing only. Static compression, bending, and torsion, and dynamic compression bending were performed according to ASTM F1717. Results demonstrate the system performs as well as or better than the predicate devices.

Technological Characteristics

Components manufactured from titanium alloy (Ti-6Al-4V) per ISO 5832-3 / ASTM F136. Design is a plate-based screw system for spinal fixation. Mechanical testing performed per ASTM F1717.

Indications for Use

Indicated for patients requiring stabilization during spinal fusion in the anterior/anterolateral thoracolumbar spine (T1-L5). Conditions include DDD, spondylolisthesis, spondylolysis, fracture, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, and revision surgery.

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

• Kaneda SR (K971248)
• MACS TL (K002824 and K032059)
• Z-Plate (K922543)

Submission Summary (Full Text)

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上101353

FEB - 4 2011

Image /page/0/Picture/2 description: The image shows the logo for Ulrich Medical USA. The word "Ulrich" is in a bold, sans-serif font, with the "U" partially overlapping a black square. Below "Ulrich" is the text "medical USA" in a smaller, sans-serif font.

### 510(k) Summary

Date: Sponsor: 21 December 2010 ulrich GmbH & Co. KG

Buchbrunnenweg 12 89081 Ulm Germany Phone: [phone] Fax: [phone]

Contact Person:

Hans Stover ulrich medical USA, Inc. 612 Trade Center Blvd. Chesterfield, MO 63005 [phone] Office [phone] Fax

Proposed Trade

golden gate™ System

Device Classification Class II

Spinal intervertebral body fixation orthosis Classification Name:

Anterior thoracolumbar plate system Common Name:

Regulation:

Name:

Code:

Device Product

KWQ

888.3060

The golden gate™ anterior plate system is used for the surgical Device Description: stabilization and fixation of the thoracolumbar spine to provide a suitable environment for fusion to occur. The fixation components of the system include plates, screws and connectors (hex nuts and inlays). These are available in a variety of sizes and lengths to accommodate differing patient anatomy.

The golden gate™ anterior plate system is intended to provide Intended Use: stabilization during the development of a spinal fusion. The golden gate™ system is indicated for use in the anterior/anterolateral thoracolumbar spine (T1-L5) for the treatment of: DDD (back pain of discogenic origin with degeneration of the disc as confirmed by Spondylolisthesis, patient history and radiographic studies), Spondylolysis, Fracture (including dislocation or subluxation), Spinal stenosis, Deformities (i.e., scoliosis, kyphosis, lordosis), Tumor, Pseudarthrosis, Revision of previous surgery.

Materials:

The golden gate™ system components are manufactured from titanium alloy (Ti-6Al-4V) as described by ISO 5832-3 / ASTM F136.

Page 1 of 2

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| Predicate Devices: | Kaneda SR (K971248)<br>MACS TL (K002824 and K032059)<br>Z-Plate (K922543) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics: | The golden gate™ System possesses the same technological<br>characteristics as the predicate devices. These include basic design<br>(rod/plate-based screw system), material (titanium or titanium alloy),<br>sizes (rod/plate lengths and screw diameters and lengths are within<br>the range(s) offered by the predicate systems) and intended use (as<br>described above). The fundamental scientific technology of the<br>golden gate™ System is the same as previously cleared devices. |
| Performance Data: | Static compression bending and torsion, and dynamic compression<br>bending of the worst case golden gate™ construct was performed<br>following ASTM F1717. The mechanical test results demonstrate that<br>the golden gate™ System performs as well as or better than the<br>predicate devices. |
| Conclusion: | The golden gate™ System is substantially equivalent to the devices<br>referenced above and is therefore as safe and as effective for its<br>intended use. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

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

FEB = 4 2011

ulrich GmbH & Co.. KG % ulrich medical USA. Inc. Mr. Hans Stover President and CEO 612 Trade Center Boulevard Chesterfield. Missouri 63005

Re: K101353

Trade/Device Name: golden gate™ System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 22, 2010 Received: December 23, 2010

Dear Mr. Stover:

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 intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Fedral Food, Dr to 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 links and warranties. We remind you; however, that device labeling must be truth tol and not muchading.

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 devices on 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.

and the country of the county of the county of

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Page 2 - Mr. Hans Stover

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 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/CDRHQffices/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/ReportalProblem/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 .-

At B. Rt
for.

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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## Indications for Use Statement

# 510(k) Number:_K|01353

#### Device Name: golden gate™ system

Indications for Use:

The golden gate™ anterior plate system is intended to provide stabilization during the development of a spinal fusion. The golden gate™ System is indicated for use in the anterior/anterolateral thoracolumbar spine (T1-L5) for the treatment of:

- . DDD (back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies),
- Spondylolisthesis, .
- Spondylolysis, .
- Fracture (including dislocation or subluxation), .
- Spinal stenosis, .
- Deformity (i.e., scoliosis, kyphosis, lordosis), ●
- Tumor, .
- Pseudarthrosis, .
- Revision of previous surgery .

| Prescription Use | X |
|------------------------|---|
| (21 CFR 801 Subpart D) | |

AND/OR

| Over-the-Counter Use | |
|------------------------|--|
| (21 CFR 807 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

Krol 353 510(k) Number_