SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM

K112025 · Spinal USA · KWP · Sep 15, 2011 · Orthopedic

Device Facts

• Record ID: K112025
• Device Name: SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM
• Applicant: Spinal USA
• Product Code: KWP · Orthopedic
• Decision Date: Sep 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to promote fusion of the cervical spine (CI-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following: -DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies) -Spondylolisthesis -Spinal Stenosis -Fracture/dislocation -Revision of previous cervical spine surgery -Tumors The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws are not intended to be placed in the cervical spine. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.

Device Story

Sure Lok Mini Posterior Cervical/Upper Thoracic System is a spinal fixation orthosis; consists of titanium alloy polyaxial screws, rods, and hooks. Used by surgeons in clinical settings to stabilize the cervical/upper thoracic spine to promote fusion. Polyaxial screws anchor the construct in the upper thoracic spine (T1-T3); hooks and rods provide stabilization in the cervical spine (C1-C7). Components are non-sterile and available in various lengths to accommodate patient anatomy. Device provides mechanical support to the spine, facilitating fusion in patients with degenerative disc disease, instability, or trauma. Surgeon selects appropriate components based on patient anatomy; implants are secured to the spine to maintain alignment during the healing process.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F1717, including static axial compression bending, static torsion, dynamic axial compression bending, and dynamic torsion tests.

Technological Characteristics

Titanium alloy spinal fixation system. Components: polyaxial screws, rods, hooks. Polyaxial ball joint locking mechanism. Non-sterile. Mechanical testing per ASTM F1717.

Indications for Use

Indicated for skeletally mature patients requiring cervical spine (C1-C7) fusion due to DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, revision surgery, or tumors. Hooks and rods indicated for stabilization following cervical trauma. Polyaxial screws restricted to T1-T3 thoracic anchoring; contraindicated for cervical spine placement.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Synthes - Cervifix System (K991089)
• Alphatec - Solanas System (K052201)
• Seaspine - Sierra System (K072729)

Submission Summary (Full Text)

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K112025 page 1/2

SEP 1 5 2011

Image /page/0/Picture/2 description: The image shows the logo for Spinal USA. The words "Spinal USA" are written in white letters on a black rectangle. A drawing of a spine is between the words "Spinal" and "USA".

2050 Executive Drive Pearl, MS 39208

Ph: 601-420-4244 Fax: [phone]

### 510(k) Summary

| Date Summary Prepared: | July 11, 2011 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Submitter Information: | Spinal USA<br>2050 Executive Drive<br>Pearl, MS 39208 |
| Contact Name:<br>Phone:<br>Fax:<br>E-mail: | Frankie Cummins<br>601-420-4244<br>601-420-5501<br>[e-mail] |
| Device Trade Name: | Sure Lok Mini Posterior Cervical/Upper Thoracic System |
| Common Name: | Spinal Interlaminal Fixation Orthosis |
| Regulatory Number: | 888.3050 |
| Classification: | Class II |
| Product Code: | K WP |
| Predicate Device: | Synthes - Cervifix System (K991089)<br>Alphatec - Solanas System (K052201)<br>Seaspine - Sierra System (K072729) |

## INTENDED USE:

When intended to promote fusion of the cervical spine (CI-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following:

-DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies) -Spondylolisthesis

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K112025 page 2/2

-Spinal Stenosis -Fracture/dislocation

- -Revision of previous cervical spine surgery
- -Tumors

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.

#### DEVICE DESCRIPTION:

The Sure Lok Mini Posterior Cervical/Upper Thoracic System consists of polyaxial screws, rods and hooks. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from titanium alloy. The components will be provided non-sterile.

#### EQUIVALENT DEVICE:

Documentation was provided which demonstrated the Sure Lok Mini Posterior Cervical/Upper Thoracic System is substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture.

Components of the Sure Lok Mini Posterior Cervical/Upper Thoracic System are similar to the predicate systems. The design concept of the polyaxial pedicle screw of the Solanas and Sierra systems are similar to the Sure Lok Mini Posterior Cervical/Upper Thoracic system. The screw thread type, size and length are similar as is the polyaxial ball joint locking mechanism and rod clamping cap screw. The same applies to the rescue screw design. The cap screw torque applied to seat the cap screw is similar to the predicates. Screw angulation is also similar. Rod design is similar to the predicate systems. Rod diameter is either the same or larger. Rod lengths are similar to the predicates. Hook type, shape, size are similar to the predicates. Cross links, domino, and offsets are similar to the predicates. Material is the same as the predicates. Sterilization is the same as the predicates.

The following mechanical testing was performed on the Sure Lok Mini Posterior Cervical/Upper Thoracic System. Testing was performed according to ASTM F1717: Static Axial Compression Bending test, Static Torsion test, Dynamic Axial Compression Bending test, and Dynamic Torsion test.

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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 stylized graphic of an eagle or bird-like figure with three wing-like shapes. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 1 (090)3 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Spinal USA % Mr. Frankie Cummins 2050 Executive Drive Pearl, Mississippi 39208

SEP 15 2001

Re: K112025

Trade/Device Name: Sure Lok Mini Posterior Cervical/ Upper Thoracic System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class H Product Code: KWP Dated: July 13, 2011 Received: July 15, 2011

Dear Mr. Cummins:

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

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Page 2 - Mr. Frankie Cummins

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/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/ResourcesforYou/Industry/default.htm.

Sincerely vours,

Sincerely yours,

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

Device Name: Sure Lok Mini Posterior Cervical/Upper Thoracic System

Indications for Use:

When intended to promote fusion of the cervical spine (CI-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following:

-DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies) -Spondylolisthesis -Spinal Stenosis -Fracture/dislocation -Revision of previous cervical spine surgery -Tumors

The use of polyaxial screws is limited to placement in the upper.thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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 (ODE)

Signature

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________