(90 days)
Not Found
Not Found
No
The device description and summary of performance studies indicate a mechanical implant for spinal fusion, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described for treating cervical disc disease, trauma, degenerative conditions, and other spinal issues, aiming to facilitate fusion and provide stabilization. This directly addresses medical conditions and aims to restore function or alleviate symptoms, fitting the definition of a therapeutic device.
No
The device is described as an implantable system (plates, screws, and screw covers) for intervertebral body fusion and anterior screw fixation of the cervical spine. Its purpose is to facilitate fusion and provide stabilization, not to diagnose a condition.
No
The device description explicitly states that the InterPlate™ C consists of physical components: plates, bone screws, and screw covers, manufactured from titanium alloy. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes the InterPlate™ C as a surgical implant system (plates, screws, and screw covers) intended for intervertebral body fusion and anterior screw fixation of the cervical spine. This is a surgical procedure performed directly on the patient's body, not a test performed on a sample outside the body.
The device is a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The InterPlate™ C is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. It is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.
In addition, the InterPlate™ C is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
WARNING: The InterPlate™ C is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Product codes
KWQ, KWO, ODP
Device Description
The InterPlate™ C consists of plates, bone screws and screw covers in a variety of sizes. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size. The InterPlate™ C components are manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, from C3 to T1
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
8. 510(k) Summary
- (
| Sponsor: | RSB Spine, LLC
3030 Superior Ave., Suite 703
Cleveland, OH 44114
Phone: 216.241.2804
Fax: 216.241.2820 | OCT - 6 2009 | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--|
| Contact Person: | James M. Moran, D. Eng.
Vice President of Engineering and Chief Technical Officer | | |
| Proposed Trade Name: | InterPlate™ C | | |
| Device Classification | Class II | | |
| Classification Name: | Appliance, fixation, spinal intervertebral body | | |
| Regulation: | 888.3060 | | |
| Device Product Code: | KWQ | | |
| Device Description: | The InterPlate™ C consists of plates, bone screws and screw covers in a
variety of sizes. Various plate sizes are available to accommodate individual
patient anatomy and graft material size. Screw covers are individually
matched to the plate size. The InterPlate™ C components are manufactured
from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. | | |
| Intended Use: | The InterPlate™ C is indicated for intervertebral body fusion of the spine in
skeletally mature patients. The device system is designed for use with
autograft to facilitate fusion. One device is used per intervertebral space. It
is intended for use at one level in the cervical spine, from C3 to T1, for the
treatment of cervical disc disease (defined as neck pain of discogenic origin
with degeneration of the disc confirmed by history and radiographic
studies). The cervical device is to be used in patients who have had six
weeks of non-operative treatment.
In addition, the InterPlate™ C is intended for anterior screw fixation of the
cervical spine. These implants have been designed to provide stabilization
as an adjunct to cervical fusion. Indications for the use of this implant
system include degenerative disc disease (defined as neck pain of
discogenic origin with the degeneration of the disc confirmed by history and
radiographic studies), spondylolisthesis, trauma (i.e., fractures or
dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or
scoliosis), tumor, pseudarthrosis or failed previous fusion.
WARNING: The InterPlate™ C is not intended for screw attachment or
fixation to the posterior elements (pedicles) of the cervical, thoracic or
lumbar spine. | | |
| Substantial
Equivalence: | Documentation was provided which demonstrated the InterPlate™ C to be
substantially equivalent to previously cleared devices. The substantial
equivalence is based upon equivalence in intended use, indications,
anatomic sites, material of manufacture and mechanical performance. | | |
.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
RSB Spine, LLC % Karen E. Warden, Ph.D. 8202 Sherman Road Chesterland, Ohio 44026
OCT - 6 2009
Re: K092070
Trade/Device Name: Interplate™ C Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO, ODP Dated: July 7, 2009 Received: July 8, 2009
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.
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 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.
2
Page 2 - Karen E. Warden, Ph.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark M Millam
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
7. Indications for Use Statement
510(k) Number:_| | 09 20 70
Device Name: InterPlate™ C
Indications for Use:
The InterPlate™ C is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. It is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.
In addition, the InterPlate™ C is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
WARNING: The InterPlate™ C is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Prescription Use X
AND/OR
Over-the-Counter Use
(21 CFR 807 Subpart C)
(21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
K092070 510(k) Number .
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