DSC/ALF SPINAL SYSTEM

K101886 · Sintea Plastek, LLC · MQP · Jul 21, 2011 · Orthopedic

Device Facts

• Record ID: K101886
• Device Name: DSC/ALF SPINAL SYSTEM
• Applicant: Sintea Plastek, LLC
• Product Code: MQP · Orthopedic
• Decision Date: Jul 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DSC/ALF Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The DSC/ALF Spinal System is to be used with supplemental fixation. Specifically, the DSC/ALF spinal system is to be used with the anterior lateral plate that is included in the system, and may also be used with the Sintea Biotech PLS Spinal System. Additionally, the DSC/ALF spinal system is intended to be used with autograft.

Device Story

Vertebral body replacement (VBR) system for thoracolumbar spine; replaces collapsed/damaged/unstable vertebrae due to tumor or trauma. System comprises hollow internal module, external module, and anterior lateral fixation (ALF) plate. Internal module slides within external module; locked via two screws into tooth rails on internal cage. Endplates optimize contact with vertebral bodies for primary stability. ALF plate connects to anterior side of vertebra via two screws; plates connected by rod. Used by surgeons in clinical settings. Provides structural support; requires supplemental fixation and autograft. Benefits patient by restoring spinal stability.

Clinical Evidence

Bench testing only. Testing performed per ASTM F2077 and ASTM F2267. Results: Static compression, static torsion, subsidence, and fatigue compression showed better results than the predicate; fatigue torsion results were comparable to the predicate.

Technological Characteristics

Materials: Medical grade titanium alloy (Ti-6Al-4V) per ASTM F136. Design: Modular VBR with sliding internal/external modules and anterior lateral fixation plate. Mechanical locking via screws into tooth rails. 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 fixation (included anterior lateral plate or Sintea Biotech PLS Spinal System) and autograft.

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

• Sintea Biotech's DSC/ALF Spinal System (K070181)

Reference Devices

• Sintea Biotech PLS Spinal System

Submission Summary (Full Text)

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K101886

JUL 21 2011

sintea PLUSTEK

DSC/ALF Spinal System 510(k) Summary June 2010

Sintea Plustek, LLC. Company: 407 Lincoln Rd. Suite 10L Miami Beach, FL 33139 [phone]

Proprietary Trade Name: DSC/ALF System II.

> 888.3060 Regulation Number: Spinal Intervertebral Body Fixation Orthosis Regulation Name: Product Code: MQP, KWQ

### III. Product Description

Sintea Plustek, LLC. 407 Lincoln Rd, Suite 10L

Miami Beach, FL 33139

P. 305-673-6226 F. 305-673-3312

l.

This 510(k) consists on the submission to add additional lengths and cross-sections, an improved locking mechanism, cage body redesign, and end-plate charges to a previously cleared system. The DSC/ALF Spinal System provides two basic components: A VBR (DSC) and an anterior lateral fixation plate (ALF). The DSC has a hollow internal module that can slide in relation to an external module, which enables the former to be locked in the most suitable position by means of two screws. These screws are inserted into two tooth rails on the internal cage, on both the anterior and posterior part, and mechanically lock the two modules. Both modules have endplates that optimize the contact with the vertebral bodies between which the device is inserted, thus ensuring better primary stability. The cages present a symmetrical geometry in order to make device placement simpler for the surgeon. The ALF is composed of two plates that connect to the anterior side of a vertebra by two screws. The two plates are connected by a rod. All components of the DSC/ALF Spinal System are made of medical grade titanium alloy (Ti-6Al-4V) as described by ASTM Standard F136.

## IV. Indications

The DSC/ALF Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-LS) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The DSC/ALF Spinal System is to be used with supplemental fixation. Specifically, the DSC/ALF spinal system is to be used with the anterior lateral plate that is included in the system, and may also be used with the Sintea Biotech PLS Spinal System. Additionally, the DSC/ALF spinal system is intended to be used with autograft.

## Performance Data - Overview V.

1. Static compression - This test on the new device achieved better results than those of the predicate device.

2. Static torsion - This test on the new device achieved better results than those of the predicate device.

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Sintea Plustek, LLC. 407 Lincoln Rd, Suite 10L Miami Beach, FL 33139 P. 305-673-6226 F. 305-673-3312

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3. Subsidence – This test on the new device achieved better results than those of the predicate device.

4. Expulsion - This test on the new device achieved comparable results to those of the predicate device.

5. Fatigue compression - This test on the new device achieved better results than those of the predicate device.

6. Fatigue torsion - This test on the new device achieved comparable results to those of the predicate device.

Testing standards followed: ASTM F2077 ASTM F2267

## VI. Substantial Equivalence

Sintea Plustek, LLC. believes that the additions to the DSC/ALF Spinal System are substantially equivalent to the Sintea Biotech's DSC/ALF Spinal System (K070181) with respect to functional design, indications for use, principles of operation, performance, and materials.

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Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread.

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

Sintea Plustek, LLC % Ms. Danielle Wernikowski 407 Lincoln Road, Suite 10L Miami Beach, FL 33139

JUL 2 1 2011

Re: K101886

Trade/Device Name: DSC/ALF Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP, KWQ Dated: July 06, 2011 Received: July 11, 2011

Dear Ms. Wernikowski:

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

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Page 2 - Ms. Danielle Wernikowski

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/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 yours.

E. I. Keith

o 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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Sintea Plustek, LLC. 407 Lincoln Rd, Suite 10L Miami Beach, FL 33139 P. 305-673-6226 F. 305-673-3312

Image /page/4/Picture/1 description: The image shows the logo for "sintea PLUSTEK". The logo consists of the company name written in a simple, sans-serif font. The entire name is enclosed within a double-lined oval shape, adding a visual element to the design. The text and oval are black.

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# Indications for Use

K101886 510(k) Number (if known):

Device Name: DSC/ALF_Spinal System

Indications for Use:

The DSC/ALF Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The DSC/ALF Spinal System is to be used with supplemental fixation. Specifically, the DSC/ALF spinal system is to be used with the anterior lateral plate that is included in the system, and may also be used with Sintea Biotech's PLS Spinal System. Additionally, the DSC/ALF spinal system is intended to be used with autograft.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

signature

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

510(k) Number K101886

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