ACROSSPINE PEDICLE SCREW SYSTEM

K141695 · Arthro-Dif · NKB · Dec 30, 2014 · Orthopedic

Device Facts

• Record ID: K141695
• Device Name: ACROSSPINE PEDICLE SCREW SYSTEM
• Applicant: Arthro-Dif
• Product Code: NKB · Orthopedic
• Decision Date: Dec 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acrosspine Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

Device Story

Pedicle screw system for posterior spinal fixation; implants include polyaxial screws (5.5-7.5mm diameter, 35-60mm length) and rods (5.5mm diameter, 40-300mm length). Constructed from unalloyed titanium and 6Al4V titanium alloy. Used by surgeons in clinical settings to provide stabilization as an adjunct to spinal fusion. Device provides mechanical support to the spine; helps restore alignment; facilitates fusion process. Benefits include stabilization of spinal segments in patients with degenerative or traumatic conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing included static/dynamic compression bending, static torsion, axial pullout, torque to failure, axial slip, flexural grip, and torsional grip.

Technological Characteristics

Materials: Unalloyed titanium and 6Al4V titanium alloy. Components: Polyaxial screws and rods. Standards: ASTM F1717-13 (compression/torsion), ASTM F543-13 (pullout/torque), ASTM F1798-97 (08) (slip/grip). Mechanical fixation system; no software or energy source.

Indications for Use

Indicated for skeletally mature patients requiring noncervical pedicle fixation (T1-S1) as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, spinal curvatures, tumor, pseudarthrosis, or failed previous 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

• Expedium System by DePuy Spine (K073126)
• S4 System by Aesculap (K090657)
• Easyspine system by LDR Spine (K082592)
• AnyPlus Spinal System by GS Medical (K091717)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right. The profiles are rendered in a simple, line-art style.

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

December 30, 2014

Arthro-DIF % Rich Jansen, Pharm.D. Silver Pine Consulting, LLC 11821 Bramble Cove Drive Fort Myers, Florida 33905

Re: K141695

Trade/Device Name: Acrosspine Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: November 28, 2014 Received: December 1, 2014

Dear Dr. Jansen:

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 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

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Page 2 - Rich Jansen, Pharm.D.

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

### K141695

Device Name

Acrosspine Pedicle Screw System

#### Indications for Use (Describe)

The Acrosspine Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fision for the following indications: degenerative disc disease (defined as back. pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthess: trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudarthrosis: and failed previous fusion.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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# 510(k) Summary K141695

| Date Prepared: | November 28, 2014 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Contact: | Jean-Charles Roussouly<br>Arthro-DIF<br>14 chemin de la Place-Pollet<br>St Maurice de Gourdans, France 01880<br>[e-mail]<br>[phone] |
| Regulatory Contact: | Rich Jansen, Pharm. D.<br>Silver Pine Consulting, LLC<br>[e-mail] |
| Trade Name: | Acrosspine Pedicle Screw System |
| Product Class: | Class III |
| Classification: | 888.3070 Pedicle Screw Spinal System |
| Common Name: | Pedicle Screw System |
| Product Codes: | NKB, MNI, MNH |
| Panel Code: | 87 |

## Indications for Use:

The Acrosspine Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

## Device Descriptions:

The Arthro-DIF Acrosspine Pedicle Screw System is an implant device made from an unalloyed titanium and 6Al4V Titanium Alloy. It is to be implanted from the posterior approach. The screws are available in 5.5, 6.5 and 7.5mm diameters and in lengths from 35-60 mm. The screws are available as polyaxial screws. All rods are available in 5.5mm diameter with curved rod in lengths from 40-100 mm, and straight rods from 150-300mm.

## Predicate Device(s):

The Arthro-DIF Acrosspine Pedicle Screw System is substantially equivalent to the Expedium System by DePuy Spine (K073126), the S4 System by Aesculap (K090657), the

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Easyspine system by LDR Spine (K082592) and the AnyPlus Spinal System by GS Medical (K091717 - Primary Predicate).

## Performance Standards:

Pre-clinical testing was performed on the Arthro-Dif Acrosspine Pedicle Screw System. Testing included:

| Test | ASTM Standard |
|--------------------------|---------------|
| Static Compression Bend | F1717-13 |
| Dynamic Compression Bend | F1717-13 |
| Static Torsion | F1717-13 |
| Axial Pullout | F543-13 |
| Torque to Failure | F543-13 |
| Axial Slip | F1798-97 (08) |
| Flexural Grip | F1798-97 (08) |
| Torsional Grip | F1798-97 (08) |

## Conclusion:

Arthro-DIF concludes that the Arthro-DIF Acrosspine Pedicle Screw System is substantially equivalent to the predicates in regard to indications for use, materials, function, sizes and mechanical test results and raises no new questions of safety or effectiveness.