(90 days)
K003155, OEC/Rezaian Spinal Fixator, DePuy Acromed Stackable
Not Found
No
The description focuses on the mechanical design and materials of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a vertebral body replacement intended to treat collapsed, damaged, or unstable vertebral bodies due to tumor or trauma, which directly addresses a medical condition and restores function.
No
Explanation: The VBR™ is described as a vertebral body replacement device, an implantable titanium alloy device used to replace diseased or damaged vertebral bodies. Its function is to provide structural support and stability, not to diagnose medical conditions or provide information for diagnostic purposes.
No
The device description clearly states it is a physical, implantable titanium alloy device with mechanical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to replace a collapsed, damaged, or unstable vertebral body in the spine due to tumor or trauma. This is a surgical implant for structural support and restoration of height.
- Device Description: The description details a physical implantable device made of titanium alloy, designed to be surgically placed in the spine. It describes its mechanical components and how it functions as a structural replacement.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The provided text does not mention any testing of biological samples or diagnostic purposes.
Therefore, the VBR™ is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VBR™ is a vertebral body replacement device intended for use in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture).
The VBR™ is intended to be used with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems.
The use of bone grafting material with the VBR™ is optional.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The VBR™ is a cylindrically shaped implantable titanium alloy device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VBRTM is also indicated for treating fractures of the thoracic and lumbar spine.
The VBR™ consists of three (3) basic components, at least two (2) of which are threaded, such that the VBR™ is distractible and retractable by means of rotating the center ring or cylinder. A plurality of holes are built in the wall of the VBR™, transverse to the longitudinal axis. A row of holes in one or more of the cylinders is threaded to accept a set screw which, when tightened, serves to prevent further movement (distraction, retraction, or turning) of the VBR™ once the desired height has been achieved. The holes and the hollow core also allow for packing of bone grafting materials to help promote a solid fusion. A ring of small spikes or teeth on each end of the device serves to grip the endplates of the adjacent vertebrae for resisting expulsion.
The VBR™ is manufactured from titanium alloy (Ti6Al4V) which conforms to ASTM F136-92 and ISO 5832/3 standards.
The VBR™ is available in different sizes. Diameters of 20-28 mm with distraction lengths from 25 mm to 130 mm have previously been cleared (K003155). This current submission covers additional diameters ranging from 12 mm to 16 mm and distraction lengths from 10 mm to 65 mm, to better match patients' anatomical requirements.
The VBR™ is for single patient use and is offered for sale non-sterile. They must be sterilized 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
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 and a clinical study have been conducted on the VBR™ with the smaller diameters to show equivalence to predicate devices and demonstrate its capability to withstand in vivo loads.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K003155, OEC/Rezaian Spinal Fixator, DePuy Acromed Stackable
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
VIII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS OCT 1 6 2001
July 13, 2001
- Submission Applicant & Correspondent:
| Name: | Osteotech, Inc. |
|---|---|
| Address: | 51 James Way Eatontown, NJ 07724 |
| Phone No.: | (732) 544-6231 |
| Contact Person: | Kim Thurman |
-
- Name of Device:
| Trade/Proprietary/Model Name: | VBRTM |
|---|---|
| Common or Usual Name: | Vertebral Body Replacement Device |
| Classification Name: | Spinal Vertebral Body Replacement Device |
3. Devices to Which New Device is Substantially Equivalent:
The VBR™ with the smaller diameter sizes (12 - 16 mm) is substantially equivalent, for the purpose of this 510(k), to the following predicate devices.
| Trade/Proprietary/Model Name | Manufacturer |
|---|---|
| VBRTM (20 - 28 mm diameters) | Ulrich GmbH & Co. KG |
| OEC/Rezaian Spinal Fixator | Orthopedic Equipment Co, Inc. |
| DePuy Acromed Stackable | DePuy AcroMed, Inc. |
-
- Device Description:
The VBR™ is a cylindrically shaped implantable titanium alloy device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VBRTM is also indicated for treating fractures of the thoracic and lumbar spine.
- Device Description:
1
510(k): VBRTM (12 - 16 mm diameters)
K012254
Osteotech, Inc.
20F3
The VBR™ consists of three (3) basic components, at least two (2) of which are threaded, such that the VBR™ is distractible and retractable by means of rotating the center ring or cylinder. A plurality of holes are built in the wall of the VBR™, transverse to the longitudinal axis. A row of holes in one or more of the cylinders is threaded to accept a set screw which, when tightened, serves to prevent further movement (distraction, retraction, or turning) of the VBR™ once the desired height has been achieved. The holes and the hollow core also allow for packing of bone grafting materials to help promote a solid fusion. A ring of small spikes or teeth on each end of the device serves to grip the endplates of the adjacent vertebrae for resisting expulsion.
The VBR™ is manufactured from titanium alloy (Ti6Al4V) which conforms to ASTM F136-92 and ISO 5832/3 standards.
The VBR™ is available in different sizes. Diameters of 20-28 mm with distraction lengths from 25 mm to 130 mm have previously been cleared (K003155). This current submission covers additional diameters ranging from 12 mm to 16 mm and distraction lengths from 10 mm to 65 mm, to better match patients' anatomical requirements.
The VBR™ is for single patient use and is offered for sale non-sterile. They must be sterilized prior to use. Detailed information regarding the VBR™ is provided in Part IV -Device Description. Information regarding sterilization is provided in Part V -Sterilization Information.
- Intended Use/Indications
The VBRTM is a vertebral body replacement device intended for use in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture).
The VBRTM is intended to be used with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems.
The use of bone grafting material with the VBR™ is optional.
6. Technical Comparison
The VBR™ with the smaller diameter sizes (12 - 16 mm) is similar to the previously cleared VBR™ in K003155 and to the Rezaian Spinal Fixator in terms of design and technical characteristics. The VBRTM and Rezaian devices are cylindrically shaped implantable devices that are distractible and retractable by means of rotating the center component. Each of these devices has a ring of small spikes which serves to grip the endplates of the adjacent vertebrae for resisting expulsion. They are also similar in dimensions. The VBR™ with the smaller diameters is also substantially equivalent to the DePuy Acromed Stackable Cage System.
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7. Performance Data
Mechanical testing and a clinical study have been conducted on the VBR™ with the smaller diameters to show equivalence to predicate devices and demonstrate its capability to withstand in vivo loads.
3
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2001
Ms. Kim Thurman Project Leader, Regulatory Affairs Osteotech. Inc. 51 St. James Way Eatontown. New Jersey 07724
Re: K012254
Trade/Device Name: VBR™ Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: July 17, 2001 Received: July 18, 2001
Dear Ms. Thurman:
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. Iisting 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.
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Page 2 - Ms. Kim Thurman
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-1697 fffee of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the O ther general manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark n Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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L. Indications for Use Statement
| 510(k) Number (if known): | K012254 |
|---|---|
| Device Name: VBR TM |
Indications for Use:
The VBR™ is a vertebral body replacement device intended for use in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture).
The VBR 11 is intended to be used with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems.
The use of bone grafting material with the VBR™ is optional.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ^ (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
for Mark n Milken
on of General, Restorative and Neurological Je
510(k) Number K012254
0000004