Arsenal Spinal Fixation System

K152968 · Alphatec Spine, Inc. · NKB · Dec 30, 2015 · Orthopedic

Device Facts

• Record ID: K152968
• Device Name: Arsenal Spinal Fixation System
• Applicant: Alphatec Spine, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Dec 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation 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/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. Additionally, the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach. The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.

Device Story

Arsenal Spinal Fixation System; posterior, non-cervical spinal fixation hardware; includes rods, screws, bridges, connectors. Provides temporary internal fixation/stabilization during bone graft healing; adjunct to fusion of thoracic, lumbar, sacral spine. Used in surgical settings by orthopedic/neurosurgeons. Implants stabilize spine segments; facilitate fusion; treat deformities/trauma/degenerative conditions. Benefits patient via spinal stabilization/correction of deformities.

Clinical Evidence

Bench testing only. Performance data includes ASTM F1717 (static/dynamic compression bending, static torsion) and ASTM F1798 (static flexion-extension moment, axial gripping capacity). Axial and maximum angle screw body pulloff testing also performed.

Technological Characteristics

Posterior spinal fixation system; components include rods, screws, bridges, connectors. Materials and design features consistent with predicate systems. Testing conducted per ASTM F1717 and ASTM F1798 standards.

Indications for Use

Indicated for skeletally mature patients requiring posterior non-cervical fixation for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, spinal curvatures, tumor, pseudarthrosis, or failed fusion. Also indicated for pediatric patients for progressive spinal deformities (idiopathic, neuromuscular, congenital scoliosis, kyphosis, lordosis), spondylolisthesis/spondylolysis, fracture, pseudarthrosis, or failed fusion via posterior approach.

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

• Arsenal Spinal Fixation System (K143149)
• Arsenal Spinal Fixation System (K133221)
• Zodiac Spinal Fixation System (K100685)
• CD Horizon Spinal System (K142591)
• PASS LP Spine System (K142798)
• Isobar Spinal System (K013440)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines extending from the profiles.

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

December 30, 2015

Alphatec Spine, Incorporated Ms. Renée L. Murphy Senior Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008

Re: K152968

Trade/Device Name: Arsenal™ Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNI, MNH, KWP Dated: October 8, 2015 Received: October 9, 2015

Dear Ms. Murphy:

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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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/ResourcesforYou/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 yours,

# 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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# Indications for Use

510(k) Number (if known) K152968

Device Name ArsenalTM Spinal Fixation System

### Indications for Use (Describe)

The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation 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/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. Additionally, the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach.

The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.

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

| <div> <span> <b> <svg height="16" width="16"> <rect height="16" style="fill:lightgrey;stroke:black;stroke-width:1" width="16"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black" stroke-width="2"></path> </svg> </b> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
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| <div> <span> <b> <svg height="16" width="16"> <rect height="16" style="fill:lightgrey;stroke:black;stroke-width:1" width="16"></rect> </svg> </b> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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### 510(k) Summary

#### I. SUBMITTER

Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Phone: [phone] Fax: [phone]

Contact Person: Renée L. Murphy Date Prepared: October 5, 2015

#### II. DEVICE

Name of Device: Arsenal™ Spinal Fixation System Common or Usual Name: Pedicle Screw System Classification Name: Pedicle screw spinal system (21 CFR 888.3070, 888.3050) Regulatory Class: III Product Code: NKB, OSH, MNI, MNH, KWP

#### III. PREDICATE DEVICE

Alphatec Spine, Arsenal Spinal Fixation System, K143149 (Primary Predicate) Alphatec Spine, Arsenal Spinal Fixation System, K133221(Additional Predicate) Alphatec Spine, Zodiac Spinal Fixation System, K100685 (Additional Predicate) Medtronic, CD Horizon Spinal System, K142591(Additional Predicate) Medicrea International SA, PASS LP Spine System, K142798(Additional Predicate) Scient'x, (Alphatec Holdings), Isobar Spinal System, K013440 (Additional Predicate)

#### DEVICE DESCRIPTION IV.

The Arsenal Spinal Fixation System is a posterior, non-cervical, spinal fixation system consisting of a variety of shapes and sizes of rods, screws, bridges and connectors to provide temporary internal fixation and stabilization during bone graft healing as an adjunct to fusion of the thoracic, lumbar and sacral spine.

The purpose of this Traditional 510(k) Premarket Notification is to add deformity implants to the currently marketed Arsenal Spinal Fixation System and expand the current pediatric indication of the Arsenal System to include treatment of progressive spinal deformities.

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#### V. INDICATIONS FOR USE

The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation 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/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.

#### VI. TECHNOLOGICAL COMPARISON TO PREDICATES

The technological design features of the subject Arsenal System implants were compared to the predicates in intended use, design, function, materials, and sizes and it was demonstrated that they are substantially equivalent.

#### VII. PERFORMANCE DATA

Performance data and engineering analysis demonstrate that the subject Arsenal System implants are substantially equivalent to the predicates. Testing and analysis include ASTM F1717 Static Compression Bending Test, Dynamic Compression Bending Test and Static Torsion Tests; ASTM F1798 testing include Static Flexion-Extension Moment (My) and Axial Gripping Capacity (FX). Additionally, Axial & Maximum Angle Screw Body Pulloff Testing was conducted.

# VIII. CONCLUSION

Based upon the information provided in this Traditional 510(k) submission, it has been determined that the subject Arsenal System implants are substantially equivalent to legally marketed devices in regards to indications for use, intended use, design, technology, and performance.