ARTS2 SPINAL FIXATION SYSTEM

K103573 · Advanced Medical Technologies · MNH · Dec 28, 2011 · Orthopedic

Device Facts

• Record ID: K103573
• Device Name: ARTS2 SPINAL FIXATION SYSTEM
• Applicant: Advanced Medical Technologies
• Product Code: MNH · Orthopedic
• Decision Date: Dec 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ART2 Spinal Fixation System is a pedicle screw 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 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 ART2 Spinal Fixation 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 (13 to sacrum) with removal of the implants after the attainment of a solid fusion.

Device Story

ART2 Spinal Fixation System is a posterior pedicle screw system for spinal stabilization. Components include color-coded top-loading pedicle screws (various lengths/diameters), rod connectors (short/long), and rods (straight/curved). Used by surgeons in clinical settings to immobilize spinal segments until fusion occurs. Device is a modification of the ART Pedicle Screw system (K033150), adding cannulated/reposition screws and additional rod sizes. System provides mechanical support to the spine; aids in treating acute/chronic instabilities or deformities. Patient benefit is stabilization of the spinal column during the fusion process.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including static and dynamic compression (ASTM F1717), static torsion (ASTM F1717), and static axial/torsional slippage (ASTM F1798). All acceptance criteria were met.

Technological Characteristics

Components manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136. System features top-loading pedicle screws, rod connectors, and rods. Mechanical fixation principle. No software or electronic components.

Indications for Use

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

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

• ART Posterior Spinal System (K033150)
• ISOBAR (K990118/K013444)

Submission Summary (Full Text)

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# 510(k) Summary

for the ART2 Spinal Fixation System

DEC 2 8 2011

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the ART2 Spinal Fixation System

Date Prepared: November 30, 2010

- Contact Person: 1. Owner: J.D. Webb Advanced Medical Technologies The OrthoMedix Group, Inc. Kasteler Strasse 11 1001 Oakwood Blvd 66620 Nonnweiler-Braunhausen Germany Round Rock, TX 78681 Telephone: [phone] Telephone: [phone] Fax: [phone] Fax: [phone]
- 2. Trade name: ART2 Spinal Fixation System Common Name: orthosis, pedicle screw system Classification Name: orthosis, spondylolisthesis spinal fixation orthosis, spinal pedicle fixation 21 CFR Sec. 888.3070 MNH MNI Class II

### Predicate or legally marketed devices which are substantially equivalent: ന്

ART Posterior Spinal System - K033150 (AMT) ISOBAR - K990118/K013444 (Scient'x)

### 4. Description of the device:

The ART2 Spinal Fixation System has been developed with the objective of providing the surgeon with an adaptable pedicle screw system in order to carry out posterior pedicle screw fixation of the spine simply, quickly and effectively. It is a modification of the ART Pedicle Screw system (K033150).

The system consists of a variety of color coded top loading pedicle screws. The pedicle screws are available in various lengths and diameters. The screw is connected to the rod connector. Two sizes of connectors are available, short and long. The long is used in cases of spondylolisthesis where the short connector would not be able to engage the rod. The rods are available in multiple lengths.

## Materials:

The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.

## Function:

The ART2 Spinal Fixation System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments until fusion takes place.

## Changes in this submission:

- Modification to pedicle screw design ●
- . Addition of Ø8.0mm screws
- � Addition of cannulated screws and reposition screws
- � Addition of Ø5.5mm straight and curved rods

### ഗ് Intended Use:

The ART2 Spinal Fixation System is a pedicle screw 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 the thoracic, lumbar, and sacral spine:

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November 30, 2010 Advanced Medical Technologies 510(k) Summary ART2 Spinal Fixation System K103573

> degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

> As a pedicle screw system ART2 Spinal Fixation 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 (13 to sacrum) with removal of the implants after the attainment of a solid fusion.

## 6. Technological characteristics compared to the predicate device(s):

ART2 Spinal Fixation System is substantially equivalent to the ART Posterior Spinal System and ISOBAR Spinal System in terms of technological characteristics, intended use, design, materials used, and performance. The information provided within this premarket notification supports substantial equivalence to the predicate device(s).

### Summary of Nonclincal Tests: 7.

The following tests were conducted:

- . Static and dynamic compression per ASTM F1717. The acceptance criteria was/were met.
- Static torsion per ASTM F1717. The acceptance criteria was/were met. .
- Static Axial Slippage per ASTM F1798. The acceptance criteria was/were met. .
- . Static Torsional Slippage per ASTM F1798. The acceptance criteria was/were met.

The results of this testing indicate that the ART2 Spinal Fixation System is equivalent to predicate device(s).

### 8. Clinical Test Summary:

No clinical studies were performed

### ರಿ. Conclusions Nonclinical and Clinical:

Conclusions drawn from the nonclinical and clinical tests demonstrate that the ART2 Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate device(s).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 2 8 2011

Advanced Medical Technologies % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock. Texas 78681

Re: K103573

Trade/Device Name: ART2 Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: December 15, 2011 Received: December 20, 2011

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. 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. J.D. Webb

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Millenson

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

KID3273 510(k) Number (if known):

ART2 Spinal Fixation System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The ART2 Spinal Fixation System is a pedicle screw 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system ART2 Spinal Fixation 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter 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)

Lirdell Castle

Division of Surgica! Orthopedic, and Restorative Devices

510(k) Number K103573