(309 days)
No
The document describes a mechanical implant for vertebral body replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "vertebral body (partial or total) replacement device" intended to "replace and restore height to a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (fracture or disease)", which indicates a therapeutic purpose.
No
Explanation: The device is described as a vertebral body replacement system, which is an implant used to replace and restore height to a collapsed, damaged, or unstable vertebral body. This is a therapeutic device, not a diagnostic one.
No
The device description explicitly details physical implants made of material, with specific shapes, sizes, and surface features designed for surgical implantation. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a vertebral body replacement system for surgical implantation in the thoracolumbar spine. This is a surgical implant, not a device used to examine specimens from the human body.
- Device Description: The description details the physical characteristics and materials of the implant, which are consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are used in vitro (outside the body) to examine specimens and provide diagnostic information. This device is used in vivo (inside the body) as a structural replacement.
N/A
Intended Use / Indications for Use
The OstaPek® VBR System are vertebral body (partial or total) replacement devices intended for use in the thoracolumbar spine (T1 - L5) to replace and restore height to a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (fracture or disease). The system is to be used in association with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended is the coLigne, AG, GII Spinal Fixation System.
Product codes
MQP
Device Description
The implants consist of a system of flattened, cuboid, trapezoida & rectangular shaped implants. The OstaPek® VBR System implants offer substantial variation of size and configuration to better approximate the anatomical variation observed in different vertebral levels and patient anatomy. The devices are manufactured with one or more hollowed out central areas to accommodate bone graft material. The superior and inferior surfaces are manufactured in such a way that a series of lands and grooves are formed in the anterior/posterior direction. The purpose of these lands and grooves is to improve stability and bony fixation once the device is inserted. This device is made from the exact same material as the GII Spinal Fixation System, K051089.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar 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)
Testing Summary. Fatigue, static and biocompatibility testing is comples were tested according to accepted engineering and scientific principals. Test results demonstrate that the new implants may be expected to perform in a manner equivalent or superior to the referenced comparison systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K07232
JUN 2 4 2008
| 510(k) Summary Information
Premarket Notification, Section 510(k) | | COLIGNE AG.
MAY 7, 2008 |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------|
| Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92 | | |
| 1. | Device Name: | |
| | Trade Name: OstaPek® VBR System | |
| | Common
Name(s): Vertebral body replacement | |
| | Classification
Name(s): Spinal vertebral body replacement device | |
| 2. | Establishment Name & Registration Number: | |
| | Name: coLigne AG.
Number: 9614472 | |
| 3. | Classification(s): | |
| | Sec. § 888.3060 | |
| | Device Class: Class II
Classification Panel: Orthopaedic and Rehabilitation Devices Panel
Product Code(s): MQP | |
| 4. | Equivalent Predicate Device: | |
coLigne AG. believes that the OstaPek® VBR is substantially equivalent to the VBR systems identified below:
K052384 - Lanx VBR, Lanx, LLC K052746 - Concord VBR, DePuy Spine, Inc. K032064 - Theken LPOD, VBR, Theken, Surgical
Equivalence can be seen in the design, material composition, surgical technique and intended use.
5. Device Description:
The implants consist of a system of flattened, cuboid, trapezoida & rectangular shaped implants. The OstaPek® VBR System implants offer substantial variation of size and configuration to better approximate the anatomical variation observed in different vertebral levels and patient anatomy. The devices are manufactured with one or more hollowed out central areas to accommodate bone graft material. The superior and inferior surfaces are manufactured in such a way that a series of lands and grooves are formed in the anterior/posterior direction. The purpose of these lands and grooves is to improve stability and bony fixation once the device is inserted. This device is made from the exact same material as the GII Spinal Fixation System, K051089.
Testing Summary. Fatigue, static and biocompatibility testing is comples were tested according to accepted engineering and scientific principals. Test results demonstrate that the new implants may be expected to perform in a manner equivalent or superior to the referenced comparison systems.
1
K072326 (pg. 2 of 2)
Indications for Use.
The OstaPek® VBR System are vertebral body (partial or total) replacement devices intended for use in the thoracolumbar spine (T1 - L5) to replace and restore height to a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (fracture or disease). The system is to be used in association with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended is the coLigne, AG, GII Spinal Fixation System.
6. Applicant Name & Address:
coLigne AG Utoquai 43 Zurich, Switzerland 8008 41-433-438000 41-433-438009 - fax Registration Number: 9614472
7. Company Contact:
Robert Lange coLigne AG Utoquai 43 Zurich, Switzerland 8008 41-433-438000 41-433-438009 – fax
Submission Correspondent: 8.
Mr. David W. Schlerf Buckman Company, Inc. 1070 Concord Avenue, Suite 230 Concord, CA 94520-5646 925.768.0247 - 925.356.2654 -- fax schlerf@comcast.net or david@fda-help.com
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
coLigne AG % Buckman Company, Inc. Mr. David Schlerf 1070 Conrad Avenue, Suite 230 Concord, CA 94520
Re: K072326
Trade/Device Name: OstaPek® VBR System Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 14, 2008 Received: June 18, 2008
Dear Mr. Schlerf:
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.
JUN 2 4 2008
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.
3
Page 2 - Mr. David Schlerf
This letter will allow you to begin marketing your device as described in your Scction 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1
14072326 510(k) Number :
Device Name(s): OstaPek® VBR System
Indications For Use:
The OstaPek® VBR System are vertebral body (partial or total) replacement devices intended for use in the thoracolumbar spine (T1 - L5) to replace and restore height to a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (fracture or disease). The system is to be used in association with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended is the coLigne, AG, GII Spinal Fixation System.
Prescription Use X OR Over-The-Counter Use PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Deubare Muehm
Division St. Oto
Division of General, Restorative, and Neurological Devices
(Per 21 CFR 801.109)
510(k) Number_K07324
(Optional format 1-2-96)
OstapekVBR.doc