(129 days)
Not Found
No
The 510(k) summary describes a mechanical vertebral body replacement device and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "vertebral body replacement device intended for use... to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma," which directly addresses a medical condition or ailment, indicating a therapeutic purpose.
No
Explanation: The device is a vertebral body replacement device, designed to provide structural support, not to diagnose medical conditions.
No
The device description clearly states it is a "titanium vertebral body replacement device," indicating it is a physical implant, not software.
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, tissue) to provide information about a person's health.
- Device Description: The SYNTHES® Contoured SynMesh® Spacer is a vertebral body replacement device made of titanium. It is surgically implanted into the spine to provide structural support.
- Intended Use: Its intended use is to replace a damaged vertebral body due to tumor or trauma and provide anterior spinal column support. This is a surgical implant, not a device used for testing samples outside the body.
The information provided clearly describes a surgical implant used for structural support within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SYNTHES® Contoured SynMesh® Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The SYNTHES® Contoured SynMesh® Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
SYNTHES® Contoured SynMesh® Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The SYNTHES® Contoured SynMesh® Spacer is intended to be used with SYNTHES® supplemental internal fixation systems, e.g., ATLP, Ventrofix, TSLP, and USS, Dual Opening USS, Small Stature USS, and Click'X. The interior of the spacer component of the SYNTHES® SynMesh® Spacer can be packed with bone.
SYNTHES® Contoured SynMesh® Spacer is designed to provide anterior spinal column support 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® Contoured SynMesh® Spacer is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy / vertebrectomy.
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
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): 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.
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
3.0 Premarket Notification 510 (k) Summary OCT 1 - 2004
| Date Prepared: | May 21, 2004 |
|---|---|
| Sponsor Information: | |
| Name and Address: | SYNTHES® Spine. |
| 1230 Wilson Drive | |
| West Chester, PA 19380 | |
| Telephone: | (484) 356-9616 |
| Contact Person: | Angela Mikroulis |
| Device Name: | |
| Trade or Proprietary Name: | SYNTHES® Contoured SynMesh® Spacer |
| Common Name: | Implant, fixation, spinal intervertebral body |
| fixation orthosis device. | |
| Classification Name/Class: | Per 21 CFR 888.3060: Spinal intervertebral |
| body fixation orthosis, Class II. | |
| Device Description: | The SYNTHES® Contoured SynMesh® Spacer |
| is a titanium vertebral body replacement device | |
| used in conjunction with supplemental internal | |
| fixation to provide structural stability in | |
| skeletally mature individuals following | |
| corpectomy / vertebrectomy. | |
| Predicate Device (s): | SYNTHES® SynMesh® Spacer System |
| (K003275) | |
| Intended Use: | The SYNTHES® Contoured SynMesh® Spacer |
| is a vertebral body replacement device intended | |
| for use in the thoracolumbar spine (T1-L5) to | |
| replace a collapsed, damaged, or unstable | |
| vertebral body due to tumor or trauma (i.e., | |
| fracture). The SYNTHES® Contoured | |
| SynMesh® Spacer is designed to provide | |
| anterior spinal column support even in the | |
| absence of fusion for a prolonged period. | |
| Material: | Commercially pure titanium |
| Substantial Equivalence: | Documentation is provided which demonstrates |
| that the SYNTHES® Contoured SynMesh® | |
| Spacer for Spinal intervertebral body fixation | |
| orthosis is Substantially Equivalent to other | |
| legally marketed SYNTHES® devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 - 2004
Ms. Angela Mikroulis Regulatory Affairs Specialist Synthes Spine 1230 Wilson Drive West Chester, Pennsylvania 19380
Re: K041389
Trade/Device Name: SYNTHES® Contoured SynMesh® Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: September 1, 2004 Received: September 3, 2004
Dear Ms. Mikroulis:
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. Angela Mikroulis
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing your arrivalence of your device to a legally premarket notheation. The PDA miang of basification 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 If you desire specific advice for your as 10-1) 276-0120. Also, please note the regulation entitled, Colliation of Compullios as (210) = 17 = 17 = 15 = 1 = 1 807.97). You may obtain Misblanding of reference to premail.orgibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or 1011) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Mark N Millman
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
3
SYNTHES® Special 510 (k): Device Modification / Line Extension SYNTHES® SynMesh Spacer System-(K003275)
2.0 Indications for Use Statement
રિભ જિલ્લ 510(k) Number (if known):
Device Name: SYNTHES® Contoured SynMesh® Spacer
Indications for Use: SYNTHES® Contoured SynMesh® Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The SYNTHES® Contoured SynMesh® Spacer is intended to be used with SYNTHES® supplemental internal fixation systems, e.g., ATLP, Ventrofix, TSLP, and USS, Dual Opening USS, Small Stature USS, and Click'X. The interior of the spacer component of the SYNTHES® SynMesh® Spacer can be packed with bone.
SYNTHES® Contoured SynMesh® Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Prescription Use______________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Mark N. Milken
Division of General, Restorative, and Neurological Devices
510(k) Number K041389
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