MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM

K080075 · Elite Surgical Supplies (Pty), Ltd. · MNI · Jan 28, 2008 · Orthopedic

Device Facts

• Record ID: K080075
• Device Name: MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
• Applicant: Elite Surgical Supplies (Pty), Ltd.
• Product Code: MNI · Orthopedic
• Decision Date: Jan 28, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vertefix® Pedicle Screw Spinal System is intended for posterior, non cervical pedicle fixation in skeletally mature patients receiving fusion by autogenous bone graft in the thoracolumbar spine for the following indications: Spondylolisthesis, Trauma (e.g.fracture or dislocation), Spinal stenosis, deformities or curvatures (scoliosis, kyphosis or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Removal of the implants after the attainment of a solid fusion is optional.

Device Story

Vertefix® Pedicle Screw Spinal System is a posterior spinal fixation construct; components include pedicle screws, rods, set screws, connectors, hooks, and transverse linking mechanisms. Used by surgeons to stabilize the spine and promote fusion in the thoracolumbar region. Components are non-sterile and single-use. System provides mechanical support to the spinal column; surgeon constructs the implant assembly intraoperatively. Benefits include spinal stabilization and support for bone graft healing. No software or electronic components.

Clinical Evidence

Bench testing only. Mechanical testing performed according to ASTM F1717 for the original system; thread pullout testing performed for the modified 5.5mm rod design.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136. Components: Pedicle screws, rods, set screws, connectors, hooks, transverse links. Mechanical testing: ASTM F1717. Sterilization: Non-sterile (single use).

Indications for Use

Indicated for skeletally mature patients requiring posterior, non-cervical pedicle fixation in the thoracolumbar spine for spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion, used with autogenous bone graft.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• Vertefix® Pedicle Screw Spinal System (K080075)

Submission Summary (Full Text)

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# K080075

### SECTION 4

## JAN 28 2008

## SECTION 4 - 510(k) SUMMARY

[As required by 21CFR807.92]

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ELITE SURGICAL SUPPLIES (PTY) LTD

P.O. Box 26115 Arcadia Pretoria 0007 South Africa

Contact Person: John O'Toole Contact Title: Managing Director Tel: [phone] Fax: [phone] Email: [e-mail]

(Please notify via email of correspondence with the Submission correspondent)

Elite Surgical Supplies Vertefix® Pedicle Screw Spinal System Page 4-1

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#### 4.1 Date Prepared [21CFR807.92(a)(1)]

November 16, 2007

#### 4.2 Submitter's Information [21CFR807.92(a)(1)]

| Company Name: | Elite Surgical US |
|-----------------|----------------------------------|
| Street Address: | 503 Commerce Park Drive, Suite I |
| City: | Marietta |
| State/Province: | Georgia |
| Country: | USA |
| Telephone: | 404-408-2396 |
| Facsimile: | 770-590-5152 |
| Contact Person: | Charise de Barros |
| Contact Title: | Agent |
| Contact Email: | [e-mail] |

#### 4.3 Trade Name, Common Name, Classification [21CFR807.92(a)(2)]

| Trade Name: | Vertefix® Pedicle Screw Spinal<br>System |
|----------------------|------------------------------------------------------------------------------|
| Common Name: | Pedicle Screw Spinal Fixation<br>System |
| Classification Name: | Spinal Pedicle Screw<br>Fixation Orthosis(MNI)<br>per 21 CFR § 888.3070 |
| | Spondylolisthesis Spinal<br>Fixation Orthosis (MNH)<br>per 21 CFR § 888.3070 |
| | Spinal Interlaminal<br>Fixation Orthosis (KWP)<br>Per 21 CFR § 888.3050 |
| Device Class: | Class II |
| Product Code: | MNI, MNH, KWP |

|

Elite Surgical Supplies Vertefix® Pedicle Screw Spinal System

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#### 4.4 Identification of Predicate Device(s) [21CFR807.92(a)(3)[

| <br>יין///---<br>1<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Screw System<br>כחומר<br>erteti | |
| 18062452<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>RE REGIONAL PROPERTY<br>---------- | |

There are no significant differences between the Vertefix® Pedicle Screw Spinal System and the approved Vertefix® Pedicle Screw Spinal System or other spinal fixation systems currently being marketed, which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, materials, operational principles and intended use.

#### 4.5 Description of the Device [21CFR807.92(a)(4)]

The Vertefix® Pedicle Screw Spinal System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, hooks, and a transverse (cross) linking mechanism.

The Vertefix® Pedicle Screw Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Vertefix® Pedicle Screw Spinal System components are supplied non-sterile, and are single use.

#### 4.6 Intended Use [21CFR807.92(a)(5)]

The Vertefix® Pedicle Screw Spinal System is intended for posterior, non cervical pedicle fixation in skeletally mature patients receiving fusion by autogenous bone graft in the thoracolumbar spine for the following indications: Spondylolisthesis, Trauma (e.g.fracture or dislocation), Spinal stenosis, deformities or curvatures (scoliosis, kyphosis or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Removal of the implants after the attainment of a solid fusion is optional.

#### 4.7 Technological Characteristics [21CFR807.92(a){6)]

The original Vertefix® Pedicle Screw Spinal System components were submitted to construct testing according to ASTM F1717.This testing demonstrated substantial equivalence to the predicate systems and other marketed systems. Further comparison to the predicates also demonstrated substantial equivalence in terms of intended use, operating principle, materials, shelf life and design. There are no significant differences between the Vertefix® spinal system, the predicate device,

#### Elite Surgical Supplies

Vertefix® Pedicle Screw Spinal System

Page 4-3

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and other systems currently marketed which would adversely affect the use of the product. The Vertefix® Spinal System components are fabricated from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available for the application. The modified system was not again submitted to the ASTM F1717 testion, as the only significant change to the system is the change to a 5.5mm rod. This will make the system perform slightly better than the already tested Vertefix Spinal System. Thread pullout testing was however performed to prove the thread design.

Elite Surgical Supplies Vertefix® Pedicle Screw Spinal System Page 4-4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Public Health Service

JAN 28 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elite Surgical Supplies Ltd. % Elite Surgical US Ms. Charise De Barros 503 Commerce Park Drive SE, Suite I Marietta, GA 30060

Re: K080075

> Trade/Device Name: Vertefix® Pedicle Screw Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH, KWP Dated: November 16, 2007 Received: January 11, 2008

Dear Ms. De Barros:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Charise De Barros

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milburn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

Applicant 510(k) Number (if known) Device Name

Elite Surgical Supplies (Pty) Ltd K080075 Vertefix® Pedicle Screw Spinal System

Indications for Use: The Vertefix® Pedicle Screw System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients receiving fusion by autogenous bone graft in the thoracolumbar spine, for the following indications:

- . Spondylolisthesis;
- . Trauma (e.g. fracture or dislocation):
- . Spinal stenosis;
- Deformities or curvatures (scoliosis, kyphosis and lordosis); .
- . Tumor;
- . Pseudoarthrosis; and
- Failed previous fusion. ●

Prescription Use OR Over-the-Counter Use X (Per 21 CFR 801.109)

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millerson

(Divi n Sign-Off) Division of General, Restorative, and Necrological Devices

510(k) Number

80078

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