ART POSTERIOR SPINAL SYSTEM

K033150 · Advanced Medical Technologies AG · MNI · Mar 1, 2004 · Orthopedic

Device Facts

• Record ID: K033150
• Device Name: ART POSTERIOR SPINAL SYSTEM
• Applicant: Advanced Medical Technologies AG
• Product Code: MNI · Orthopedic
• Decision Date: Mar 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ART Posterior Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as a n adjurce to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). As a pedicle screw system ART Posterior Spinal System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The hooks are intended for posterior, nonpedicle screw fixation of the noncervical spine; hook and sacral/iliac screw fixation to the noncervical spine; and hook and sacral screw fixation to the T1-S1 spine.

Device Story

Posterior spinal fixation system; includes monoaxial/polyaxial pedicle screws, rods, rod-to-rod connectors (Domino), cross connectors, and hooks. Screws inserted into bone; rods attached via top-loading connectors. Connector design allows 20° angular variation between screw and connector to reduce rod bending. System used by surgeons in clinical settings for spinal fusion procedures. Provides mechanical stabilization of spinal segments; promotes fusion; treats deformities and instabilities. Implants intended for removal after solid fusion attainment.

Clinical Evidence

Bench testing only. Testing performed according to ASTM F1717 standards.

Technological Characteristics

System components include monoaxial and polyaxial pedicle screws, rods, connectors, and hooks. Top-loading connector design allows 20° angular adjustment. Materials and specifications conform to ASTM F1717 for mechanical testing. Non-software, mechanical spinal fixation system.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions including degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudarthrosis. Also indicated for severe (Grade 3-4) L5-S1 spondylolisthesis using autogenous bone graft with L3-sacrum fixation.

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

• ISOBAR Pedicle Screw System (K990118)
• ISOBAR Pedicle Screw System (K013444)

Submission Summary (Full Text)

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510(k) Summary

**Date**
September 29, 2003

MAR - 1 2004

### Submitter

Advanced Medical Technologies AG Kasteler Strasse 11 66620 Nonnweiler-Braunshausen Germany

## Contact person

J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199

Common name

Posterior spinal system

#### Classification name

Spondylolisthesis spinal fixation device system 888.3070 Pedicle screw spinal system 888.3070 Spinal interlaminal fixation orthosis 888.3050

#### Equivalent Device

Equivalent Device
The ART Posterior System is similar in design, material and indications as the ISOBAR Pedicle Screw System (Scient'x, K990118 and K013444).

#### Device Description

Device Describution
Pedicle Screws, monoaxial and polyaxial, are available in various lengths and diameters. The Screw is connected to Federe Screws, nonoaxian and polyamin, are a in lengths ranging from 40mm to 500mm. The Screw is inserted the Rod Via a Not Connector and inserted in the bone. As a top loading system the Connector has a Uthrough an opening the Rod. The interior of the U-shaped opening in the Connector is threaded to accept a Shaped Opening that accepts the Rod. The Connector. The necessity for rod bending is reduced by the ability to vary the angle between the screw and connector up to 20°.

A rod connector component, called a Domino, attaches two rods for use in multi-level fusions. Rods can be connected in series or parallel.

A Cross Connector, of varying lengths, attaches to the rods to provide rotational stability to the construct.

Pedicle, laminar and transverse hooks are also part of the system. The rods attach to the hooks and can be used for single or multiple level fixations.

#### Intended Use

Intended USE
The ART Posterior Spinal System is a pedicle screw system intended to provide immobilization of The ART I oseror in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and spiners signients in skelemities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with chionic insabilities of detorinates of the moration, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system ART Posterior Spinal System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft (Uraces J and 4) of the 155 UT verseau in disacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The hooks are intended for posterior, nonpedicle screw fixation of the noncervical spine; hook and sacraViliac screw fixation to the noncervical spine; and hook and sacral screw fixation to the T1-S1 spine.

#### Summary Nonclinical Tests

Testing was performed according to ASTM F1717.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2004

Advanced Medical Technologies AG C/o Mr. J.D.Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K033150

Trade/Device Name: ART Posterior Spinal System Regulatory Number: 21 CFR 888.3070, 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI, MNH, KWP Dated: February 14, 2004 Received: February 23, 2004

Dear Mr. Webb:

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. J.D.Webb

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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) number (if known): _ | (0 3 })50

evice Name: AR

Device Name:

Indications for Use:

K033150

# ART Posterior Spinal System Indications for Use

The ART Posterior Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as a n adjurce to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system ART Posterior Spinal System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The hooks are intended for posterior, nonpedicle screw fixation of the noncervical spine; hook and sacral/iliac screw fixation to the noncervical spine; and hook and sacral screw fixation to the T1-S1 spine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE

Prescription Use (per 21 CFR 801.109)

OR

Over-the-Counter Use

(Optional format 1-2-96) _

ﻤﺴﺎ

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

510(k) Number Division of General, Restorative. and Neurological Devices

510(k) Number_K033/50

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