(256 days)
Not Found
No
The document describes a mechanical vertebral body replacement device and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to treat diseased vertebral bodies due to tumor or trauma to achieve anterior decompression of the spinal cord and neural tissues, and to restore biomechanical integrity.
No
The device is a vertebral body replacement device, intended for surgical implantation to restore structural stability after a vertebral body has been removed due to disease or trauma. Its purpose is to replace, not diagnose.
No
The device description clearly describes a physical implantable device made of radiolucent and radiopaque materials, including a plate, screws, and a spacer component. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the SynFix-LR is a vertebral body replacement device intended for surgical implantation in the spine to replace a diseased or fractured vertebral body. It is a physical implant used to restore structural integrity.
- Lack of Biological Sample Testing: There is no mention of the device interacting with or analyzing biological samples from the patient. Its function is purely mechanical and structural.
Therefore, the SynFix-LR falls under the category of a medical device (specifically, an implantable device), but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SynFix-LR is a stand-alone vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial vertebrectomy procedures for the treatment of tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues. The interior of the spacer component of the SynFix-LR can be packed with bone (autograft or allograft).
The SynFix-LR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The Synthes SynfixTM-LR is a combination radiolucent and radiopaque vertebral body replacement device that provides structural stability in skeletally mature individuals following corpectomy. The SynfixTM-LR may be used to accommodate the anatomical requirements of the space created by the corpectomy. Four screws are inserted through the anteriorly-located plate into the adjacent vertebral bodies. The screws lock securely to the plate using a tapered-thread locking mechanism. The SynfixTM-LR is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.
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
skeletally mature individuals
Intended User / Care Setting
Prescription Use
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): 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.
K011037 – Synthes Vertebral Spacer, K010530 – Interpore Cross GeoTM Structure
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
KOLLOBS
4.0 510 (k) Summary
APR - 3 2007
| Name of Firm: | Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) Contact: | Bonnie Smith, RAC
Synthes Spine Regulatory Affairs |
| Trade Name: | SynFixTM-LR |
| Common /
Classification Name: | Vertebral Body Replacement |
| Device Product
Code and
Classification: | MQP
21 CFR 888.3060
Class II |
| Predicates: | K011037 – Synthes Vertebral Spacer
K010530 – Interpore Cross GeoTM Structure |
| Device Description: | The Synthes SynfixTM-LR is a combination radiolucent and
radiopaque vertebral body replacement device that provides
structural stability in skeletally mature individuals following
corpectomy. The SynfixTM-LR may be used to accommodate the
anatomical requirements of the space created by the corpectomy.
Four screws are inserted through the anteriorly-located plate into
the adjacent vertebral bodies. The screws lock securely to the plate
using a tapered-thread locking mechanism.
The SynfixTM-LR is available as assembled components in various
heights and geometries to suit individual pathology and anatomical
conditions. |
| Intended Use/
Indications for Use: | The SynFix-LR is a stand-alone vertebral body replacement
device intended for use in the thoracolumbar spine (T1-L5) to
replace a diseased vertebral body resected or excised during
partial vertebrectomy procedures for the treatment of tumor or
trauma (i.e. fracture) to achieve anterior decompression of the
spinal cord and neural tissues. The interior of the spacer
component of the SynFix-LR can be packed with bone
(autograft or allograft).
The SynFix-LR is designed to restore the biomechanical
integrity of the anterior, middle, and posterior spinal column
even in the absence of fusion for a prolonged period. |
page 1 of 1
Revised Indications for SynFix™-LR Spacer – K062083
Response to Request for Additional Information
CONFIDENTIAL
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes Spine % Ms. Bonnie Smith Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
APR - 3 2007
K062083 Trade/Device Name: SynFix™-LR Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertabral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: February 1, 2007 Received: February 2, 2007
Dear Ms. Smith:
Re:
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 – Ms. Bonnie Smith
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millam
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K062083
5.0 Indications for Use Statement
Device Name: SynFix™-LR
Indications for Use:
The SynFix-LR is a stand-alone vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial vertebrectomy procedures for the treatment of tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues. The interior of the spacer component of the SynFix-LR can be packed with bone (autograft or allograft).
The SynFix-LR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Murk A. Millican
Division of General, Restorative, and Neurological Devices
510(k) Number K062083
Day 1 of 1
Revised Indications for SynFixTM-LR Spacer - K062083 Response to Request for Additional Information
CONFIDENTIAL