(79 days)
No
The device description focuses on the mechanical components and materials of a cervical spine plate and screw system. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
Yes
The device is intended for the anterior plate and screw fixation of the cervical spine (C2-C7) as a treatment for various medical conditions, including Degenerative Disc Disease, Spondylolisthesis, Trauma, Spinal Stenosis, and Tumors. These uses directly address and alleviate medical conditions, thus making it a therapeutic device.
No.
The document describes a surgical implant system for spinal fixation, not a device used to diagnose medical conditions or diseases.
No
The device description clearly states it consists of physical components like plates, screws, and a plate clip, all made of specific materials. This indicates a hardware medical device, not a software-only one.
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, such as blood, urine, or tissue, to provide information about a person's health.
- Synthes Vectra-T System Function: The provided description clearly states that the Synthes Vectra-T System is a surgical implant used for anterior plate and screw fixation of the cervical spine. It is a physical device implanted into the body to provide structural support and stability.
- Lack of Diagnostic Activity: The device does not perform any tests on biological samples to diagnose a condition or provide information about a patient's health status through analysis of those samples. Its function is purely mechanical and structural.
The information provided describes a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
Synthes Vectra-T System is indicated for the following:
Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Spinal Stenosis, Tumors (primary and metastatic), Failed previous fusions, Pseudoarthrosis, Deformity (i.e., scoliosis, kyphosis, and/or lordosis).
Product codes
KWQ
Device Description
The Synthes Vectra-T System consists of one-level to four-level plates with cancellous and cortex fixed-angle and variable-angle screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7). The plate uses a translating mechanism for the screw carriage to slide to accommodate for bone graft resorption. There is a removable spacer that holds the screw carriage in place during screw placement.
The plates and screws are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb), the same as K050451 Vectra System. The plate clip is manufactured from Elgiloy (40Co-20Cr-16Fe-15Ni-7Mo), the same as K050451 Vectra System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
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)
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
3 510(k) Summary
SEP - 9 2005
| Name of Firm: | Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Susan Lewandowski
Senior Regulatory Affairs Specialist
Telephone: 610-719-5712
Facsimile: 610-719-5102 |
| Trade Name: | Synthes Vectra-T System |
| Common Name: | Cervical Plating Instrumentation |
| Device Product Code
and Classification: | KWQ – 888.3060 – Spinal Intervertebral Body Fixation Orthosis
Class II |
| Substantially
Equivalent Devices: | K971883 - Synthes CSLP-SS (Cervical Spine Locking Plate –
Small Stature), cleared October 16, 1997
K030866 – CSLP (added DDD indication), cleared April 18, 2003
K050451 - Synthes Vectra System, cleared March 24, 2005 |
| Device Description: | The Synthes Vectra-T System consists of one-level to four-level
plates with cancellous and cortex fixed-angle and variable-angle
screws. The plate attaches to the anterior portion of the vertebral
body of the cervical spine (C2-C7). The plate uses a translating
mechanism for the screw carriage to slide to accommodate for
bone graft resorption. There is a removable spacer that holds the
screw carriage in place during screw placement.
The plates and screws are manufactured from Titanium
Aluminum Niobium (Ti-6Al-7Nb), the same as K050451 Vectra
System. The plate clip is manufactured from Elgiloy (40Co-
20Cr-16Fe-15Ni-7Mo), the same as K050451 Vectra System. |
| Intended Use /
Indications for Use: | Synthes Vectra-T System is intended for anterior plate and screw
fixation of the cervical spine (C2-C7).
Synthes Vectra-T System is indicated for the following:
Degenerative Disc Disease (DDD) (defined as neck pain of
discogenic origin with degeneration of the disc confirmed by |
| history and radiographic studies), Spondylolisthesis, Trauma (i.e., | |
| fractures or dislocations), Spinal Stenosis, Tumors (primary and | |
| ' metastatic), Failed previous fusions, Pseudoarthrosis, Deformity | |
| (i.e., scoliosis, kyphosis, and/or lordosis) | |
.
1
page 2 of 2
Page 5 of 16
Traditional 510(k)
CONFIDENTIAL
Synthes Vectra T System
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is black.
SEP - 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan Lewandowski Senior Regulatory Affairs Specialist Synthes Spine 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K051665
Trade/Device Name: Synthes Vectra-T System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: June 21, 2005 Received: June 22, 2005
Dear Ms. Lewandowski:
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.
3
Page 2-Ms. Susan Lewandowski
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 vours,
Nil Re Opln
Mark N. Mellekerson
Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2 Indications for Use Statement
Traditional 510(k) Premarket Notification
Indications for Use Statement
| 510(k) Number (if known): | K 051665 |
|---|---|
| Device Name: | Synthes Vectra-T System |
| Indications for Use: | Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7). |
| Synthes Vectra-T System is indicated for the following: | |
| Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)SpondylolisthesisTrauma (i.e., fractures or dislocations)Spinal StenosisTumors (primary and metastatic)Failed previous fusionsPseudoarthrosisDeformity (i.e., scoliosis, kyphosis, and/or lordosis) |
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Prescription Use X (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 IF NEEDED)
Neilop for mum
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K051665
CONFIDENTIAL
Synthes Vectra T Syster
Page 3 of 16 Traditional 510(k)