SFC VERTEBRAL BODY REPLACEMENT

K110153 · Konigsee Implantate GmbH · MQP · Oct 12, 2011 · Orthopedic

Device Facts

• Record ID: K110153
• Device Name: SFC VERTEBRAL BODY REPLACEMENT
• Applicant: Konigsee Implantate GmbH
• Product Code: MQP · Orthopedic
• Decision Date: Oct 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SFC™ has been designed to be used in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). SFC.10 is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in thoracic and/or lumbar spine such as posterior pedicle screw and rod system, anterior plate systems, and anterior screw and rod systems. The SFCTM may be used with autograft or allograft.

Device Story

Expandable vertebral body replacement (VBR) spacer; maintains vertebral body spacing and angulation post-vertebrectomy. Implanted in thoracolumbar spine (T1-L5) by surgeons. Used in conjunction with supplemental fixation systems (pedicle screws/rods, anterior plates). Supports use of autograft or allograft bone graft. Benefits patient by restoring spinal stability and structural integrity following vertebral body loss due to trauma or tumor.

Clinical Evidence

Bench testing only. Testing adhered to ASTM F2077 and ASTM F2267 standards, including static axial compression, static axial torsion, static compression shear, dynamic axial compression, dynamic axial torsion, subsidence, and expulsion. All requirements met.

Technological Characteristics

Expandable VBR spacer; material: Ti6Al4V; performance standards: ASTM F2077, ASTM F2267.

Indications for Use

Indicated for patients with collapsed, damaged, or unstable vertebral bodies in the thoracolumbar spine (T1-L5) resulting from tumor or trauma (fracture). Requires use with supplemental FDA-cleared spinal fixation systems.

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

• Innovotec SEC VBR (K091743)
• Aesculap Hydrolift VBR (K083186)
• Synthes Synex II (K061891)

Submission Summary (Full Text)

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K110153 @CT 1 2 2011

# 510(k) Summary

| Manufacturer: | Königsee Implantate GmbH<br>OT Aschau, Am Sand 4,<br>07426 Allendorf - GERMANY |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dated Prepared: | January 10, 2011 |
| Device Trade Name: | Spinal Fusion Carrier (SFCTM) VBR |
| Contact: | Justin Eggleton<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>Office: 202.552.5800<br>Fax: [phone] |
| Classification: | 21 CFR §888.3060 |
| Class: | II |
| Product Code: | MQP |

### Indications For Use:

SFC™ has been designed to be used in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). SFC.10 is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in thoracic and/or lumbar spine such as posterior pedicle screw and rod system, anterior plate systems, and anterior screw and rod systems. The SFCTM may be used with autograft or allograft.

### Device Description:

The SFCTM acts as an expandable spacer to maintain proper vertebral body spacing and angulation following vertebrectomy. The SFCTM VBR is manufactured from Ti6Al4V.

### Predicate Device(s):

The SFC™ was shown to be substantially equivalent to previously cleared devices (Innovotec SEC VBR, K091743; Aesculap Hydrolift VBR, K083186; Synthes Synex II, K061891) and has the same indications for use, design, function, and materials used.

#### Performance:

Testing performed on this device indicates that the SFC™ is substantially equivalent to predicate devices. ASTM F2077 and ASTM F2267 performance standards (static axial compression, static axial torsion, static compression shear, dynamic axial compression,

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dynamic axial torsion, subsidence, and expulsion) were adhered to and all applicable requirements were met.

## Conclusions:

The subject and predicate devices share the same indications for use, design, function, and materials of manufacture. The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates. The AccuLIF Cage was shown to be substantially equivalent to the cited predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines above it, representing health and well-being.

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

OCT 1 2 2011

Konigsee Implantate GmbH % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton 1331 H Street NW. 12th Floor Washington, District of Columbia 20005

Re: K110153

Trade/Device Name: Konigsee Implantate Spinal Fusion Carrier (SFC") VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: September 26, 2011 Received: September 27, 2011

Dear Mr. Eggleton:

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 devine (1 rith 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.

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Page 2 - Mr. Justin Eggleton

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 of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (OS) 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/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/Industrv/default.htm.

Sincerely vours.

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

# 510(k) Number (if known): _ k 1/0153

Device Name: Königsee Implantate Spinal Fusion Carrier (SFC™) VBR

SFC 131 has been designed to be used in the thoracolumbar spine (Ti to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). SFCTM is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in thoracic and/or lumbar spine such as posterior pedicle screw and rod system, anterior plate systems, and anterior screw and rod systems. The SFC™ may be used with autograft or allografi.

ly Prescription Use (Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (29 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)

Di

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

510(k) Number_ KI10153