SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM

K051697 · Medical Device Advisory Development Group · MNH · Sep 21, 2005 · Orthopedic

Device Facts

• Record ID: K051697
• Device Name: SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM
• Applicant: Medical Device Advisory Development Group
• Product Code: MNH · Orthopedic
• Decision Date: Sep 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Selective-Axis Posterior Noncervical Plating System is intended for use as a posterior, noncervical (thoracic, lumbar and sacral), pedicle screw fixation system for the following indications: degenerative disc disease ("DDD") (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis. trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudoarthrosis, and failed fusion.

Device Story

Posterior pedicle screw fixation system; used as adjunct to spinal fusion. Components include multiangular anchor screws, longitudinal connecting beams, and jam nuts. Implanted by surgeons in clinical/OR settings to stabilize thoracic, lumbar, and sacral spine segments. Provides mechanical stabilization to facilitate fusion in patients with degenerative, traumatic, or neoplastic spinal conditions. Benefits include structural support for spinal segments during healing process.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s (May 3, 2004).

Technological Characteristics

Components: anchor screw assemblies, connecting beams, jam nuts. Material: Ti6Al4V-ELI titanium alloy per ASTM F136. Design: multiangular pedicle screw system with longitudinal connectors and locking nuts. Non-sterile, intended for surgical implantation.

Indications for Use

Indicated for patients requiring posterior, noncervical (thoracic, lumbar, sacral) pedicle screw fixation for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, tumor, pseudoarthrosis, or failed fusion.

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

• EBI's SpineLink-II Spinal Fixation System
• Scient'x Aladyn Rigid Spine Plate

Submission Summary (Full Text)

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# SEP 2 1 2005

# 451697

# 510(k) SUMMARY

### Medical Device Advisory Development Group's Selective-Axis Posterior Noncervical Plating System

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Medical Device Advisory Development Group 560 Old Ranch Road Seal Beach, CA 90740

Phone: [phone] Facsimile: 562-594-6583

Contact Person: Robert S. Howland

Date Prepared: June 22, 2005

#### Name of Device and Name/Address of Sponsor

Selective-Axis Posterior Noncervical Plating System

Medical Device Advisory Development Group 560 Old Ranch Road Seal Beach, CA 90740

#### Common or Usual Name

Posterior Pedicle Screw System

#### Classification Name

Orthosis, Spinal Pedicle Fixation; Orthosis, Spondylolisthesis Spinal Fixation (21 C.F.R. § 888.3070); Product Code: MNI, MNH

#### Predicate Devices

EBI's SpineLink-II Spinal Fixation System Scient'x Aladyn Rigid Spine Plate

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#### Intended Use / Indications for Use

The Selective-Axis Posterior Noncervical Plating System is intended for use as a posterior, noncervical (thoracic, lumbar and sacral), pedicle screw fixation system for the following indications: degenerative disc disease ("DDD") (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis. trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudoarthrosis, and failed fusion.

#### Technological Characteristics and Substantial Equivalence

The Selective-Axis Posterior Noncervical Plating System ("Selective-Axis Plating System") is comprised of the following components: Selective-Axis anchor screw assemblies, connecting beam assemblies, and jam nuts. All of the components of the Selective-Axis Plating System are manufactured from Ti6Al4V-ELI titanium alloy per ASTM F136.

The Selective-Axis Plating System is substantially equivalent* to the other currently marketed spinal systems which are referenced above. The Selective-Axis Plating System and its predicate devices all employ multiangular pedicle screws, longitudinal plates or bars that connect the pedicle screws, cross-linking connectors that connect the longitudinal plates or bars, and locking nuts with similar technological features to stabilize the spine as

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^* Any statement made in conjunction with this submission regarding an FDA determination of substantial equivalence to any other product is intended only to relate to whether the product can be marketed lawfully under FDA's section 510(k) premarket notification process. The term "substantial equivalence" as used herein is not related to "substantial equivalence" as the term is used in the patent context. [See Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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an adjunct to fusion. Thus, the Selective-Axis Plating System raises no new issues of safety or effectiveness.

#### Performance Data

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Mechanical testing of the Selective-Axis Plating System was performed in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s, dated May 3, 2004.

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# SEP 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Device Advisory Development Group C/o C. Stephen Lawrence Hogan & Hartson L.L.P. Century Centre 2603 Main Street. Suite 1170 Irvine, CA 92614

Re: K051697

Trade/Device Name: Selective-Axis Posterior Noncervical Plating System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: June 22, 2005 Received: June 23, 2005

Dear Mr. Lawrence:

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 – Mr. C. Stephen Lawrence

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.

M. J. Molloy

Mark N. Melkerson Acting 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 Form

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Selective-Axis Posterior Noncervical Plating System

Indications for Use:

The Selective-Axis Posterior Noncervical Plating System is intended for use as a posterior, noncervical (thoracic, lumbar and sacral) pedicle screw fixation system for the following indications: degenerative disc disease ("DDD") (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudoarthrosis, and failed fusion.

Prescription Use V (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Z

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** COS1697

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