(91 days)
MC+ Partial VBR, SynFix™ - LR, Stalif™ TT, Telescopic Plate Spacer
Not Found
No
The summary describes a mechanical implant (plates, screws, and covers) for spinal fusion and makes no mention of software, algorithms, or any AI/ML related terms or concepts.
Yes.
The device is used to restore biomechanical integrity to the spine damaged by tumor or trauma, which is a therapeutic purpose aiming to treat a medical condition.
No
The device description indicates it is a surgical implant designed to replace vertebrae and facilitate fusion, not to diagnose a condition.
No
The device description explicitly states it consists of plates, bone screws, and screw covers, 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 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 information clearly describes a surgical implant used to replace damaged vertebrae in the spine. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The InterPlate™ VBR is a surgical implant used for spinal fusion.
N/A
Intended Use / Indications for Use
The InterPlate™ VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumbar spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The InterPlate™ VBR device is intended to be used with a supplemental internal fixation system.
Product codes
MQP
Device Description
The InterPlate™ VBR consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and lumbar spine, from T1 to L5
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MC+ Partial VBR, SynFix™ - LR, Stalif™ TT, Telescopic Plate Spacer
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
AUG 1 8 2006
510(k) Summary
| Sponsor: | RSB Spine, LLC
3030 Superior Ave., Suite 703
Cleveland, OH 44114 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | James M. Moran, D. Eng.
Vice President of Engineering and Chief Technical Officer |
| Proprietary
Trade Name: | InterPlate™ VBR System |
| Classification
Name | 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Device Product
Code: | MQP |
| Device
Description: | The InterPlate™ VBR consists of plates, bone screws and screw covers. Various
plate sizes are available to accommodate individual patient anatomy and graft
material size. Screw covers are individually matched to the plate size. |
| Intended Use: | The InterPlate™ VBR device is indicated for the replacement of a complete or
partial vertebrectomy, when used with a bone graft to facilitate fusion. It is
designed to restore biomechanical integrity of the thoracic and lumber spine, from
T1 to L5, which has been damaged due to a collapsed or unstable vertebral body
resulting from a tumor or traumatic injury. The InterPlate™ VBR device is
intended to be used with a supplemental internal fixation system. |
| Materials: | The InterPlate™ VBR System components are manufactured from Ti-6Al-4V
titanium alloy (ASTM F136). |
| Substantial
Equivalence: | Documentation was provided which demonstrated the InterPlate™ VBR
System to be substantially equivalent to previously cleared devices including
the MC+ Partial VBR (LDR Spine USA), the SynFix™ - LR (Synthes USA),
the Stalif™ TT (Surgicraft, LTD) and the Telescopic Plate Spacer (Interpore
Cross International). The substantial equivalence is based upon equivalence in
intended use, indications, anatomic sites, performance and material of
manufacture. |
·
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a caduceus-like symbol with three parallel lines representing the branches of government, and a stylized eagle with its wings spread, symbolizing protection and service.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2006
RSB Spine, LLC % Karen E. Warden, Ph.D. Representative/Consultant 8202 Sherman Road Chesterland, Ohio 44026
Re: K061401
Trade/Device Name: InterPlate™ VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: July 26, 2006 Received: July 31, 2006
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 such 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buck MD
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number: K061 401
Device Name: InterPlate ™ Vertebral Body Replacement (VBR) System
Indications for Use:
The InterPlate™ VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumbar spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The InterPlate™ VBR device is intended to be used with a supplemental internal fixation system.
Prescription Use X (Per 21 CFR 801.109) OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Vreeland
vision of General, nes and Neurological Devices
510(k) Number K061401