(149 days)
No
The device description and performance studies focus on the mechanical properties and surgical implantation of a spinal plate system, with no mention of AI or ML capabilities.
Yes
The device is intended to immobilize and stabilize spinal segments as an adjunct to fusion for treating various acute and chronic instabilities of the thoracic and lumbar spine, which are therapeutic actions.
No
The provided text describes a surgical implant system designed to provide stabilization and immobilization of spinal segments, not a device used to diagnose a condition.
No
The device description explicitly states that the system consists of physical components such as rigid plates, bone screws, and set screws made of titanium alloy, along with surgical instrumentation. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The SKYHAWK Lateral Plate System is a surgical implant consisting of plates, screws, and instruments used to stabilize the spine. It is physically implanted into the patient's body.
- Intended Use: The intended use is to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions. This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
The information provided clearly describes a surgical implant used for treatment, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SKYHAWK Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1 to L5 with the following indications:
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- Spondylolisthesis;
- Spinal stenosis;
- Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- Tumor;
- Pseudoarthrosis;
- Failed previous fusion; and
- Trauma (i.e., fracture or dislocation).
Product codes
KWQ
Device Description
The SKYHAWK Lateral Plate System consists of an assortment of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) rigid plates, bone screws, and set screws. The plates attach by means of screws to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). The system includes instrumentation which assists in the surgical implantation of the devices. The SKYHAWK Lateral Plate System implants 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
thoracic and lumbar spine (T1-L5)
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 Lateral Plate System consisting of static and dynamic axial compression bending testing and static torsion testing was conducted in accordance with ASTM F1717-13 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." Test results demonstrate that the SKYHAWK Lateral Plate System performs as well or better than the predicate device and is therefore substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K080407, K023498, K091071, K061789, K120092
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
OFIX:
5.0
SKYHAWK™ Lateral Plate System
.'
510(k) Summary
2014
K140260 page 1 of 2
Date Prepared: | May 30, 2014 |
---|---|
Purpose for Submission: | New product offering |
Sponsor: | Orthofix |
Troy Brooks, RAC | |
3451 Plano Parkway | |
Lewisville, Texas 75056 | |
214-937-2047 | |
Device Name: | SKYHAWK™ Lateral Plate System |
Product Code: | KWQ |
Classification: | Class II - 21 CFR § 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
Predicate Device: | Blackstone Medical Spinal Fixation System (SFS) - K080407 |
Blackstone Medical Spinal Fixation System (SFS) - K023498 | |
NuVasive Lateral Plate System - K091071 | |
NuVasive Lateral Plate System - K061789 | |
Globus Medical Plymouth Thoracolumbar Plate System - K120092 | |
Device Description: | The SKYHAWK Lateral Plate System consists of an assortment of non- |
sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) rigid | |
plates, bone screws, and set screws. The.plates attach by means of screws | |
to the anterolateral or lateral portion of the vertebral body of the | |
thoracolumbar spine (T1-L5). The system includes instrumentation which | |
assists in the surgical implantation of the devices. The SKYHAWK Lateral | |
Plate System implants and instruments are provided non-sterile. They | |
require sterilization prior to use. | |
Intended Use: | The SKYHAWK Lateral Plate System is intended to be used as a non- |
pedicle lateral or anterolateral fixation system in skeletally mature patients | |
and is intended to provide immobilization and stabilization of spinal | |
segments, as an adjunct to fusion in the treatment of the following acute | |
and chronic instabilities of the thoracic and lumbar spine. It may be used | |
from levels T1 to L5 with the following indications: | |
Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);Spondylolisthesis;Spinal stenosis;Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);Tumor;Pseudoarthrosis;Failed previous fusion; andTrauma (i.e., fracture or dislocation). | |
Non-Clinical Testing: | Mechanical testing of the SKYHAWK Lateral Plate System consisting of |
static and dynamic axial compression bending testing and static torsion | |
testing was conducted in accordance with ASTM F1717-13 "Standard Test | |
Methods for Spinal Implant Constructs in a Vertebrectomy Model." Test |
1
Image /page/1/Picture/0 description: The image shows the word "ORTHOFIX" in a bold, sans-serif font. To the left of the word is a stylized, abstract symbol that resembles a curved shape. The asterisk symbol is present to the right of the word.
page 2 of 2
results demonstrate that the SKYHAWK Lateral Plate System performs as well or better than the predicate device and is therefore 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 Lateral Plate System is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2014
Orthofix, Incorporated Troy Brooks, RAC Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K140260
Trade/Device Name: SKYHAWK™ Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 30, 2014 Received: June 2, 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.
ff 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/McdicalDevices/Safctv/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 (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
4
Image /page/4/Picture/0 description: The image shows the word "ORTHOFIX" in bold, black letters. To the left of the word is a black graphic that resembles a stylized letter "O". The font of the word is sans-serif, and the letters are closely spaced together. The overall impression is a clean and modern logo.
4.0 Indications for Use Statement
510(k) Number (if known): K 140260
Device Name: SKYHAWKTM Lateral Plate System
Indications for Use:
The SKYHAWK Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels Tl to L5 with the following indications:
- · Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- · Spondylolisthesis;
- · Spinal stenosis;
- · Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- · Tumor;
- · Pseudoarthrosis;
- · Failed previous fusion; and
- · Trauma (i.e., fracture or dislocation).
Prescription Use x AND/OR (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)