SKYHAWK INTERBODY FUSION SYSTEM

K140709 · Orthofix, Inc. · MAX · May 27, 2014 · Orthopedic

Device Facts

• Record ID: K140709
• Device Name: SKYHAWK INTERBODY FUSION SYSTEM
• Applicant: Orthofix, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: May 27, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SKYHAWK Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The SKYHAWK Interbody Fusion System is designed for use with autogenous bone graft to facilitate fusion. The system is also intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the SKYHAWK Interbody Fusion System.

Device Story

Interbody fusion system consisting of implants, trials, and instruments; implants fabricated from PEEK (ASTM F2026) with tantalum markers (ASTM F560) for radiographic visualization. Designed for lateral or anterolateral implantation to restore spinal curvature. Used by surgeons in spinal fusion procedures; requires autogenous bone graft and supplemental internal fixation. Radiopaque markers aid intra/postoperative positioning. Non-sterile; requires sterilization before use.

Clinical Evidence

Bench testing only. Mechanical testing included static and dynamic axial compression, static and dynamic compression shear, and static subsidence testing per ASTM F2077-11 and ASTM F2267-04.

Technological Characteristics

Materials: PEEK Optima LT1 (ASTM F2026) and tantalum markers (ASTM F560). Form factor: Parallel and lordotic profiles. Non-sterile; requires sterilization. Mechanical testing per ASTM F2077-11 and ASTM F2267-04.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous lumbar levels (L2-S1), including those with up to Grade 1 spondylolisthesis or prior non-fusion surgery, following at least 6 months of failed non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Orthofix FORZA Spacer System (K103111)
• NuVasive CoRoent System (K071795)
• Medtronic PERIMETER Interbody Fusion Device (K131669)

Submission Summary (Full Text)

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K140709 Page 1 of 2

SKYHAWK™M Interbody Fusion System

#### 5.0 510(k) Summary

### MAY 2 7 2014 May 22, 2014 Date Prepared: Purpose for Submission: New product offering Sponsor: Orthofix Troy Brooks, RAC 3451 Plano Parkway Lewisville, Texas 75056 214-937-2047 SKYHAWK™ Interbody Fusion System Device Name: MAX Product Code: Classification: Class II - 21 CFR § 888.3080 - Intervertebral Body Fusion Device Predicate Device: Orthofix FORZA Spacer System - K103111 NuVasive CoRoent System - K071795 Medtronic PERIMETER Interbody Fusion Device - K131669 The SKYHAWK Interbody Fusion System consists of implants, trials, and Device Description: instruments. The SKYHAWK Interbody Fusion System is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK Optima LT1) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK is utilized due to its radiolucent properties, which aids the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in xrays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively. The SK YHAWK Interbody Fusion System implants are offered in parallel and lordotic profiles to restore the natural curvature of the spine; the device mav be implanted using a lateral or anterolateral approach. The SKYHAWK Interbody Fusion System implants, trials and instruments are provided non-sterile. They require sterilization prior to use. Intended Use: The SK YHAWK Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The SKYHAWK Interbody Fusion System is designed for use with autogenous bone graft to facilitate fusion. The system is also intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the SK YHAWK Interbody Fusion System. .

MAY 2, 2023

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K140709 Page 2 of 2

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## SKYHAWK™ Interbody Fusion System

Non-Clinical Testing: Mechanical testing of the SKYHAWK Interbody Fusion System consisting of static and dynamic axial compression testing, static and dynamic compression shear testing, and static subsidence testing was conducted in accordance with ASTM F2077-11 "Test Methods for Intervertebral Body Fusion Devices" and ASTM F2267-04 "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression." Test results demonstrate that the SK YHAWK Interbody Fusion System is substantially equivalent to the predicate device.

#### Conclusion:

Based upon similarities in design, materials, intended use, indications for use and the results of mechanical testing, the SKYHAWK Interbody Fusion System is substantially equivalent to the predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

May 27, 2014

Orthofix, Incorporated Troy Brooks, RAC Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K140709

Trade/Device Name: SKYHAWK™ Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 31, 2014 Received: April 1, 2014

Dear Mr. Brooks:

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 - Troy Brooks, RAC

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/McdicalDeyices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You mav 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.

## Ronald P. Jean -S for

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

Enclosure

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#### 4.0 Indications for Use Statement

510(k) Number (if known): K140709

Device Name: SKYHAWK™ Interbody Fusion System

Indications for Use:

The SKYHAWK Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

The SKYHAWK Interbody Fusion System is designed for use with autogenous bone graft to facilitate fusion. The system is also intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. "

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the SKYHAWK Interbody Fusion System.

AND/OR

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Anton E. Dmitriev, PhD Division of O