(127 days)
No
The 510(k) summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are based on mechanical testing.
Yes
The device aids in cervical spinal fusion and provides temporary stabilization of the anterior spine for various medical conditions, including degenerative disc disease, spinal stenosis, trauma, and tumors. These are therapeutic interventions aimed at treating or alleviating medical conditions.
No
The device, the DeGen Medical Hyper-C Anterior Cervical Plate system, is described as an aid in cervical spinal fusion and is intended for temporary stabilization. Its components are plates and bone screws designed to provide stabilization. There is no mention of it being used to diagnose conditions; its purpose is to aid in treatment.
No
The device description explicitly states it consists of cervical plates and bone screws, which are physical hardware components made of Titanium alloy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "aid in cervical spinal fusion" and "temporary stabilization of the anterior spine during the development of cervical spine fusions." This describes a surgical implant used directly on the patient's body.
- Device Description: The device is described as "cervical plates and bone screws" made of titanium alloy. These are physical implants.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
- Performance Studies: The performance studies described are mechanical tests (compression, torsion, screw strength, push-out) relevant to the structural integrity and function of a surgical implant, not analytical or clinical performance studies typical for IVDs.
Therefore, the DeGen Medical Hyper-C Anterior Cervical Plate system is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DeGen Medical Hyper-C Anterior Cervical Plate system is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Hyper-C Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indications:
- Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Spinal Stenosis
- Trauma (i.e. fracture or dislocation)
- Deformity or curvatures (including scoliosis, kyphosis, or lordosis)
- Spinal Tumors
- Pseudoarthrosis or failed previous fusion
- Spondylolisthesis
- Decompression of the spine following total or partial cervical vertebrectomy
Product codes
KWO
Device Description
The DeGen Medical Hyper-C Anterior Cervical Plate Systems consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The HACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options.
The system is provided in both sterile and non-sterile versions. The system is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at levels C2 to T1
Indicated Patient Age Range
Not Found
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
Non-clinical testing was performed to demonstrate the DeGen Medical Hyper-C Anterior Cervical Plate System (HACP) is substantially equivalent to other predicate devices in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. The following tests were performed:
- Static and dynamic compression testing per ASTM F1717
- Static torsion testing per ASTM F1717
- Screw strength via ASTM F543
- Push-out testing for Locking Screws
The results of these studies show the subject DeGen Medical Hyper-C Anterior Cervical Plate System (HACP) meets or exceeds the performance of the predicate devices, and the device was therefore found to be substantially equivalent.
Key Metrics
Not Found
Predicate Device(s)
K142237 Stryker Aviator Anterior Cervical Plating System
Reference Device(s)
K083562 Stryker Aviator Anterior Cervical Plating System, K971883 Synthes Small Stature Anterior Cervical Locking Plate System, K030866, K031276, K926453, K945700 Synthes CSLP, K052292 X-Spine Spider Cervical Plate, K01387, K121658 Orthofix Hallmark Anterior Cervical Plate System
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
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2015
DeGen Medical % Linda Braddon, Ph.D. President/Chief Executive Officer Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188
Re: K150759
Trade/Device Name: Hyper-C Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: June 25, 2015 Received: July 1, 2015
Dear Dr. Braddon:
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
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Page 2 - Linda Braddon, Ph.D.
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
| 510(k) Number (if known) | K150759 |
|---|---|
| K150759 | Page 1 of 1 |
| Device Name |
Hyper-C Anterior Cervical Plate System
Indications for Use (Describe)
The DeGen Medical Hyper-C Anterior Cervical Plate system is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Hyper-C Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indications:
- Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Spinal Stenosis
- · Trauma (i.e. fracture or dislocation)
- Deformity or curvatures (including scoliosis, kyphosis, or lordosis)
- Spinal Tumors
- Pseudoarthrosis or failed previous fusion
- Spondylolisthesis
- Decompression of the spine following total or partial cervical vertebrectomy
Type of Use (Select one or both, as applicable) □ Over-The-Counter Use (21 CFR 801 Subpart C) 区 Prescription Use (Part 21 CFR 801 Subpart D)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary of Safety and Effectiveness
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the DeGen Medical HACP is provided below.
| Date Summary Prepared | June 25, 2015 |
|---|---|
| Manufacturer/Distributor/Sponsor | DeGen Medical |
| 1321-C North Cashua Drive | |
| Florence, SC 29501 | |
| Phone 877-240-7838 | |
| Fax 843-407-0545 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| LGB@SecureBME.com | |
| Trade Name | Hyper-C Anterior Cervical Plate System |
| Common Name | Spinal intervertebral body fixation orthosis |
| Code -Classification | KWQ |
| 21 CFR 888.3060 : Class II | |
| Primary Predicate | K142237 Stryker Aviator Anterior Cervical Plating System |
| Reference Devices | K083562 Stryker Aviator Anterior Cervical Plating System |
| K971883 Synthes Small Stature Anterior Cervical Locking Plate System | |
| K030866, K031276, K926453, K945700 Synthes CSLP | |
| K052292 X-Spine Spider Cervical Plate | |
| K01387, K121658 Orthofix Hallmark Anterior Cervical Plate System | |
| Device Description | The DeGen Medical Hyper-C Anterior Cervical Plate Systems consists of |
| cervical plates and bone screws. All implants are intended to provide | |
| stabilization of the cervical vertebrae. The HACP provides anterior | |
| fixation from either fixed or variable angle construct in self-tapping or | |
| self-drilling bone screw options. |
The system is provided in both sterile and non-sterile versions. The
system is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. |
| Indications for Use | The DeGen Medical Hyper-C Anterior Cervical Plate system is intended for
use as an aid in cervical spinal fusion and is intended for unilateral
fixation. The Hyper-C Anterior Cervical Plate system is intended for
anterior intervertebral screw fixation of the cervical spine at levels C2 to
T1. The system is indicated for temporary stabilization of the anterior
spine during the development of cervical spine fusions in patients with
following indications:
• Degenerative Disc Disease (as defined by neck pain of
discogenic origin with degeneration of the disc confirmed by
patient history and radiographic studies)
• Spinal Stenosis
• Trauma (i.e. fracture or dislocation)
• Deformity or curvatures (including scoliosis, kyphosis, or
lordosis)
• Spinal Tumors
• Pseudoarthrosis or failed previous fusion
• Spondylolisthesis
• Decompression of the spine following total or partial cervical
vertebrectomy |
| Technological Characteristics | As was established in this submission, the subject Hyper-C Anterior
Cervical Plate System (HACP) is substantially equivalent to other predicate
devices cleared by the FDA for commercial distribution in the United
States. The subject device was shown to be substantially equivalent and
has the same technological characteristics to its predicate devices through
comparison in areas including design, intended use, material composition,
function, and range of sizes. |
| Non-Clinical Performance Testing
Conclusion | Non-clinical testing was performed to demonstrate the DeGen Medical
Hyper-C Anterior Cervical Plate System (HACP) is substantially equivalent
to other predicate devices in accordance with "Guidance for Industry and
FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. The
following tests were performed:
• Static and dynamic compression testing per ASTM F1717
• Static torsion testing per ASTM F1717
• Screw strength via ASTM F543
• Push-out testing for Locking Screws
The results of these studies show the subject DeGen Medical Hyper-C
Anterior Cervical Plate System (HACP) meets or exceeds the performance
of the predicate devices, and the device was therefore found to be
substantially equivalent. |
| Substantial Equivalence
Summary (Conclusion) | Based on the indications for use, technological characteristics,
performance testing, and comparison to predicate devices, the subject
DeGen Medical Hyper-C Anterior Cervical Plate System (HACP) has been
shown to be substantially equivalent to legally marketed predicate
devices |
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