(56 days)
Not Found
No
The summary describes a mechanical implant system for spinal fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The "Intended Use / Indications for Use" section lists several medical conditions (e.g., Degenerative Disc Disease, trauma, tumors) for which the device is intended to treat or manage, which is characteristic of a therapeutic device.
No
The device is described as an anterior screw fixation system for the cervical spine, used for treatment of various conditions. It does not perform any diagnostic function.
No
The device description explicitly states it consists of plates and screws made from Titanium Alloy and Elgiloy, which are hardware components.
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. They are used outside the body.
- Device Description: The Synthes Anterior Cervical Compression System is a system of plates and screws designed for surgical implantation into the cervical spine. It is used inside the body to provide structural support and fixation.
- Intended Use: The intended use is for anterior screw fixation to the cervical spine for various conditions. This is a surgical procedure, not a diagnostic test performed on a specimen.
Therefore, based on the provided information, the Synthes Anterior Cervical Compression System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synthes Anterior Cervical Compression System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: Degenerative Disc Disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions, pseudoarthrosis, and deformity (defined as kyphosis, lordosis or scoliosis).
Product codes
KWQ
Device Description
The Synthes Anterior Cervical Compression System consists of plates with cortical and cancellous screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The implants of these systems are manufactured from Titanium Alloy (Ti-6A1-7Nb) and Elgiloy (40Co-20Cr-16Fe-15Ni-7Mo).
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
:
FEB - 5 2004
3. 510(k) Summary
| Submitter | Synthes Spine
1230 Wilson Drive
West Chester, PA 19380 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Susan Lewandowski
(484) 356-9614
lewandowskis@synthes.com |
| Name of the Device | Synthes Anterior Cervical Compression System |
| Predicate Device | Synthes Anterior Cervical Locking Plate - K031276 |
| Device Description | The Synthes Anterior Cervical Compression System consists of
plates with cortical and cancellous screws. The plate attaches
to the anterior portion of the vertebral body of the cervical
spine (levels C2-C7).
The implants of these systems are manufactured from Titanium
Alloy (Ti-6A1-7Nb) and Elgiloy (40Co-20Cr-16Fe-15Ni-7Mo). |
| Intended Use | Synthes Anterior Cervical Compression System is intended for
anterior screw fixation to the cervical spine (C2-C7) for the
following indications: Degenerative Disc Disease (DDD),
spondylolisthesis, trauma (including fractures), spinal stenosis
and tumors (primary and metastatic), failed previous fusions,
pscudoarthosis, and deformity (defined as kyphosis, lordosis or
scoliosis). |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. 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 bird with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 2004
Ms. Susan Lewandoski Project Manager, Regulatory Affairs Synthes Spine 1230 Wilson Drive West Chester, Pennsylvania 19380
Re: K033844
Trade/Device Name: Synthes Anterior Cervical Compression System (ACCS) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 9, 2003 Received: December 11. 2003
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither 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 - Ms. Susan Lewandoski
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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsma/dsmamain.html
Sincerely vours.
Mark A. Milliken
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
Page 1 of 1
2. Indications for Use Statement
Special 510(k) Device Modification
INTENDED USE STATEMENT
| 510(k) Number (if known): | K033844 |
|---|---|
| Device Name: | Synthes Anterior Cervical Compression System |
| (Modification to Synthes Anterior Cervical Locking Plate) | |
| Indications | Synthes Anterior Cervical Compression System is |
| intended for anterior screw fixation to the cervical | |
| spine (C2-C7) for the following indications: | |
| Degenerative Disc Disease (DDD), | |
| spondylolisthesis, trauma (including fractures), | |
| spinal stenosis and tumors (primary and metastatic), | |
| failed previous fusions, pseudoarthrosis, and | |
| deformity (defined as kyphosis, lordosis or | |
| scoliosis). |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Preseription Use (Per 21 CFR 801.109)
OR Over-the-Counter Use
Mark A. Mulhern
. NEUROLOGICAL EXAMINATION