(42 days)
Not Found
No
The summary describes a mechanical implant system for spinal fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is designed for anterior screw fixation to the cervical spine to treat various medical conditions such as degenerative disc disease, fractures, and spinal stenosis, which are therapeutic interventions.
No
The device is described as an implantable cervical plate system used for anterior screw fixation in the cervical spine. Its intended uses (e.g., degenerative disc disease, fractures, tumors, deformity) are all conditions that it is designed to treat or stabilize, not diagnose.
No
The device description explicitly states it consists of physical implants (plates and screws) made of metal, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Ozark Cervical Plate System: The description clearly states that this is a system of plates and screws intended for surgical implantation into the cervical spine for fixation. It is a physical implant used to stabilize the spine, not a device that analyzes biological samples.
The information provided about the device's intended use, device description, mechanical testing, and predicate devices all point to it being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
Ozark™ Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
Product codes
KWO
Device Description
The Ozark Cervical Plate System consists of variable and fixed screws having self-tapping and self-starting tips, and one- through five-level plates. The implants are offered both sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of the Ozark Cervical Plate System constructs was performed according to ASTM F1717 and included static and dynamic compression and static torsion. The mechanical test results demonstrate that the Ozark Cervical Plate System device performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K152281, K130030, K103491, K023133, K030866
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
K2M Inc. % Karen E. Warden, PhD BackRoads Consulting, Inc. PO Box 566 12520 Heath Road Chesterland, Ohio 44026
August 23, 2017
Re: K172104
Trade/Device Name: Ozark™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: July 11, 2017 Received: July 12, 2017
Dear Dr. Warden:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 (DICE) 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/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 (DICE) 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.
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)
K172104
Device Name Ozark™ Cervical Plate System
Indications for Use (Describe)
Ozark™ Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
Type of Use (Select one or both, as applicable)
∑ Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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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This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Section 8 - 510(k) Summary
| Date: | 11 July 2017 |
|---|---|
| Sponsor: | K2M Inc. |
| 600 Hope Pkwy. SE | |
| Leesburg, Virginia 20175 | |
| Phone: 703.777.3155 | |
| Sponsor Contact: | Nancy Giezen |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Trade Name: | Ozark™ Cervical Plate System |
| Common Name: | Anterior cervical plate system |
| Regulatory Class: | Class II |
| Classification Name, | |
| Regulation, Product | |
| Code: | Appliance, fixation, spinal intervertebral body, 888.3060, KWQ |
| Device Description: | The Ozark Cervical Plate System consists of variable and fixed screws |
| having self-tapping and self-starting tips, and one- through five-level plates. | |
| The implants are offered both sterile and non-sterile. | |
| Intended Use: | Ozark™ Cervical Plate System is indicated for use in anterior screw fixation |
| to the cervical spine (C2-T1) for the following indications: degenerative disc | |
| disease (DDD) (defined as neck pain of discogenic origin with degeneration | |
| of the disc confirmed by history and radiographic studies), spondylolisthesis, | |
| trauma (including fractures), spinal stenosis and tumors (primary and | |
| metastatic), failed previous fusions (pseudarthrosis) and deformity (defined | |
| as scoliosis, kyphosis or lordosis). | |
| Materials: | The Ozark Cervical Plate System implants are manufactured from titanium |
| alloy as described by ASTM F136 and ASTM F1472. | |
| Primary Predicate: | Pyrenees Cervical Plate System (K2M - K152281) |
| Additional Predicates: | Additional: Zavation Cervical Plate System (Zavation LLC - K130030), |
| SKYLINE® Anterior Cervical Plate System (DePuy Spine Inc. - K103491, | |
| VueLock® Anterior Cervical Plate System (Biomet Spine [nee EBI] - | |
| K023133), Cervical Spine Locking Plate (CSLP) (Synthes Spine - K030866) | |
| Performance Data: | Mechanical testing of the Ozark Cervical Plate System constructs was |
| performed according to ASTM F1717 and included static and dynamic | |
| compression and static torsion. | |
| The mechanical test results demonstrate that the Ozark Cervical Plate | |
| System device performance is substantially equivalent to the predicate | |
| devices. | |
| Technological | |
| Characteristics: | The Ozark Cervical Plate System possesses the same technological |
| characteristics as the predicate devices. These include: | |
| design features, | |
| ● | |
| material, | |
| ● | |
| anatomic location and, | |
| ● | |
| dimensional attributes. | |
| ● | |
| Therefore the fundamental scientific technology of the Ozark Cervical Plate | |
| System devices is the same as previously cleared devices. |
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The Ozark Cervical Plate System possesses the same intended use and Conclusion: technological characteristics as the predicate devices. Therefore the Ozark Cervical Plate System is substantially equivalent for its intended use.