SCIENT'X SPINAL SYSTEM

K062912 · Scient'X · MNI · Feb 5, 2007 · Orthopedic

Device Facts

• Record ID: K062912
• Device Name: SCIENT'X SPINAL SYSTEM
• Applicant: Scient'X
• Product Code: MNI · Orthopedic
• Decision Date: Feb 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Scient'x Spinal System is a posterior, noncervical pedicle and non-pedicle system 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 thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, disfocation, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

Device Story

Scient'x Spinal System is a posterior, non-cervical pedicle and non-pedicle fixation system; consists of monoaxial/polyaxial pedicle screws, rigid/semi-rigid rods, and crosslink members. Used for single or multiple level spinal fixations. Implanted by surgeons in clinical settings to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Modifications include expanded screw diameters and polyaxial mechanism variations. Device provides mechanical support to the spine to facilitate fusion and treat instabilities or deformities.

Clinical Evidence

Bench testing only. Mechanical properties evaluated using ASTM F1717 standard test methods for spinal implant constructs in a vertebrectomy model.

Technological Characteristics

Materials: Ti6Al4V alloy (ASTM F136, ISO 5832-3). Components: Monoaxial/polyaxial pedicle screws, rigid/semi-rigid rods, crosslink members. Mechanical testing performed per ASTM F1717.

Indications for Use

Indicated for skeletally mature patients requiring immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. Treats degenerative spondylolisthesis with neurological impairment, fracture, dislocation, kyphosis, spinal tumor, and pseudoarthrosis.

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

• Polyaxial hemispherical screw (K051063)
• Polyaxial U Screws (K013444)
• U Screw (K990118)
• Hemispherical headed screw (K990118)
• MX Polyaxial screw (K043001)
• MX Monoaxial (K042964)
• LTD Polyaxial Screw (K062785)

Submission Summary (Full Text)

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### Special 510(k) Summary for the Scient"x Spinal System

K062912
Page 1 of 1

This safety and effectiveness summary for the Scient'x Spinal System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

Date Prepared: January 9, 2007

- 1. Submitter: Scient'x Batiment Calypso Parc Ariane 3 78284 Guyancourt FRANCE
Contact Person: J.D. Webb The OrthoMedix Group, I. c. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: [phone]

FEB - 5 2007

2. Trade name: Common Name: Classification Name:

Scient'x Spinal System posterior pedicle screw system Pedicle screw spinal system 21 CFR 888.3070 MNI/MNH

### 3. Predicate or legally marketed devices which are substantially equivalent:

- Scient'x previously cleared devices: .
- Polyaxial hemispherical screw K051063 o
- Polyaxial U Screws K013444 o
- U Screw K990118 O
- Hemispherical headed screw K990118 ਼
- MX Polyaxial screw K043001 o
- MX Monoaxial K042964 o
- LTD Polyaxial Screw K062785 (US Spine) .

### 4. Description of the device:

The Scient'x Spinal System consists of monoaxial pedicle screws, rigid rods and crosslink members, semi-rigid rods, polyaxial screws, cross link and closed and open screws. It can be used for single or multiple level fixations. The modifications included in this submission is the addition of Polyaxial LP Screws, and additional sizes of Polyaxial TTL U Screws, Polyaxial TTL High U-screw, Monoaxial TTL U Screws, Polyaxial Hemispherical Screws, MX Polyaxial Screws, MX Monaxial Screws - Closed and MX Monaxial Screws - Open.

#### Materials:

Ti6Al4V alloy, conforming to ASTM F136 and ISO 5832-3

#### 5. Intended Use:

The Scient'x Spinal System is a posterior, noncervical pedicle and non-pedicle system 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 thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, disfocation, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

### 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:

The Scient'x pedicle screws included in this submission to previous Scient'x pedicle screws and a recently cleared US Spine screw. All have the same indications and material, and similar designs. Changes are confined to modification of screw diameter and/or polyaxial mechanism.

### 7. Summary of Nonclincal Tests

Testing was undertaken to determine the mechanical properties of the pedicle screw systems. Testing was performed following the protocol of ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEE - a 200

Scient'x c/o Mr. J.D. Webb The Orthomedix Group, Incorporated 1101 Oakwood Boulevard Round Rock, Texas 78681

> K062912 Trade/Device Name: Scient'x Spinal System Regulation Number: 21 CFR §888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNI, MNH, KWP, KWP, KWQ Dated: September 22, 2006 Received: September 27, 2006

Dear Mr. Webb:

Re:

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 beer 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.

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Page 2 - Mr. J.D. Webb

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. 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 your 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

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

510(k) Number (if known): _ K0629/2

Device Name: __ Scient'x Spinal System_

Indications for Use:

The Scient'x Spinal System is a posterior, noncervical pedicle and non-pedicle system 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 thoracic, lumbar and sacral spine:

- Degenerative spondylolisthesis with objective evidence of neurological ♥ impairment,
- Fracture, .
- Dislocation, .
- Kyphosis,
- Spinal tumor, and
- Failed previous fusion (pseudoarthrosis).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chailare Borchurs fr. myy
(Division Sign)

storative. and Neurologacal Devices

510(k) Number K062912