(30 days)
No
The device description focuses on the mechanical components (plates, screws) and materials, with no mention of software, algorithms, or any capabilities that would typically involve AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for the fixation of the cervical spine to treat various spinal conditions, indicating a therapeutic purpose.
No
This device is described as a system for anterior plate and screw fixation of the cervical spine, consisting of plates and screws for surgical implantation. It is clearly a therapeutic/implantable device, not a diagnostic one.
No
The device description clearly states it consists of physical components (plates, screws, plate clip) made of specific materials, intended for surgical implantation. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Synthes VECTRA System Function: The Synthes VECTRA 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.
- Intended Use: The intended use clearly describes a surgical procedure and the conditions it is used to treat (degenerative disc disease, trauma, etc.). It does not involve analyzing biological specimens.
- Device Description: The device description details the materials and physical characteristics of the plates and screws, which are components of a surgical implant.
The Synthes VECTRA System is a surgical implant/device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Synthes Vectra System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
Synthes Vectra 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 System consists of one-level to four-level plates with cancellous and cortical 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 is 2.5 mm thick, has bigger graft visibility windows (as compared to the predicate device), bend grooves, and fixed-angle screw DTS Guide orientation holes.
The plates and screws are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb), the same as the predicate device. The plate clip is manufactured from Elgiloy (40Co-20Cr-16Fe-15Ni-7Mo), the same as the predicate device.
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
Not Found
Key Metrics
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
MAR 2 4 2005
3 510(k) Summary
| Name of Firm: | Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Susan Lewandowski
Spine Regulatory Affairs Specialist
Telephone: 610-719-5712
Facsimile: 610-719-5102 |
| Trade Name: | Synthes Vectra System |
| Common Name: | Cervical Plating Instrumentation |
| Device Product Code
and Classification: | KWQ - 888.3060 - Spinal Intervertebral Body Fixation Orthosis
Class II |
| Substantially
Equivalent Devices: | Synthes ACCS - K033844 |
| Device Description: | The Synthes Vectra System consists of one-level to four-level
plates with cancellous and cortical 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 is 2.5 mm thick,
has bigger graft visibility windows (as compared to the predicate
device), bend grooves, and fixed-angle screw DTS Guide
orientation holes.
The plates and screws are manufactured from Titanium
Aluminum Niobium (Ti-6Al-7Nb), the same as the predicate
device. The plate clip is manufactured from Elgiloy (40Co-20Cr-
16Fe-15Ni-7Mo), the same as the predicate device. |
| Intended Use /
Indications for Use: | Synthes Vectra System is intended for anterior plate and screw
fixation of the cervical spine (C2-C7).
Synthes Vectra 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
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces left and is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2005
Ms. Susan Lewandowski Senior Regulatory Affairs Specialist Synthes Spine 1302 Wrights Lane East West Chester, PA 19380
Re: K050451
Trade/Device Name: Synthes VECTRA System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: February 18, 2005 Received: February 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
2
Page 2 -- Ms. Susan Lewandowski
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
t (2005) (2006) (2006) (2006) (2006) (2005) (21 CFR 1000-1050, forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Scetions 95 de scessi)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin marketing your artice of your device of your device to a legally
premarket notification. The FDA finding of substantial equiraced thus, p premarket notification. The FDA Innung of subsantial equive 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
rs in the many of the many of any of 6 0100 - Also - plasse note the regula If you desire specific advice for your uevice on our nooning nease note the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the re contact the Office of Compliance at (240) 270 - FR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obt Small "Misbranding by reference to premarkst nothlean (1)" on the Division of Small
other general information on your responsibilities under the Act from the 1800) 638-204 other general intornation on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its foll-free number (800) htm Manufacturers, International and Consumer Assistantes of the councilindustry/support/index.html.
Sincerely yours,
Stupk Rlurdu
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Special 510(k) Device Modification
Indications for Use Statement
| 510(k) Number
| (if known): | K050451 |
|---|---|
| Device Name: | Synthes VECTRA System [modification to Synthes Anterior |
| Cervical Compression System (ACCS)] | |
| Indications for Use: | Synthes VECTRA System is intended for anterior plate and screw |
| fixation of the cervical spine (C2-C7). | |
| Synthes VECTRA 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) | |
| 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styptik Alurku
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________