(67 days)
Not Found
No
The summary describes a mechanical interbody fusion system made of PEEK with tantalum markers. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is described as an "Interbody Fusion System" indicated for "spinal fusion procedures," which is a treatment for degenerative disc disease. Its purpose is to facilitate fusion and restore spinal curvature, which are therapeutic actions.
No
The device is an interbody fusion system designed for spinal fusion procedures. Its purpose is to facilitate fusion, not to diagnose medical conditions. Diagnostic information (like confirmed degeneration of the disc) is used to select patients for this device, but the device itself is a treatment, not a diagnostic tool.
No
The device description explicitly states that the system consists of implants, trials, and instruments made from materials like PEEK and tantalum, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for spinal fusion procedures, which is a surgical intervention. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is an implantable system made of PEEK and tantalum markers, along with trials and instruments for surgical implantation. This is a medical device used in the body, not a diagnostic tool used on specimens from the body.
- Lack of Diagnostic Function: The device's function is to facilitate spinal fusion, not to diagnose a condition or provide information about a patient's health status through analysis of biological samples. The tantalum markers are for visualization during and after surgery, not for diagnostic purposes.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The SKYHAWK Interbody Fusion System consists of implants, trials, and 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2-S1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
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.(b)
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.
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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
1
K140709 Page 2 of 2
Image /page/1/Picture/1 description: The image shows the word "ORTHOFIX" in bold, black letters. To the left of the word is a black graphic that looks like a stylized letter "O". A small trademark symbol is located to the upper right of the word.
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.
2
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
3
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)