(203 days)
No
The device description and intended use focus solely on a mechanical fixation system for cervical spine fusion, with no mention of AI/ML capabilities or related data processing.
Yes
The device is stated to be used for the treatment of various spinal conditions, indicating a therapeutic purpose.
No
The device is a cervical plate system intended for surgical fixation and fusion, not for diagnosing medical conditions.
No
The device description clearly states it is a "fixation system" consisting of "Plates" and "screws," which are physical 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, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The description clearly states that the Active " Anterior Cervical Plate System is a "fixation system" consisting of plates and screws. These are implants designed to be surgically placed inside the body to stabilize the cervical spine.
- Intended Use: The intended use is for the "treatment of the cervical spine in skeletally mature patients receiving fusion." This involves a surgical procedure and the implantation of a device, not the analysis of bodily specimens.
Therefore, based on the provided information, the Active " Anterior Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Active "10 Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implants after the attainment of a solid fusion mass. The Active ™ Anterior Cervical Plate System is intended for use under the following indications:
· Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Trauma (i.e., fracture or dislocation)
- · Spinal stenosis
· Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) - Tumor
- · Pseudoarthrosis
- · Failed previous fusion
Product codes
KWO, KWQ
Device Description
The Active " Anterior Cervical Plate System is a fixation system designed to allow for settling of the bone graft during fusion. Plates are provided in various lengths to accommodate fusions from 1 to 4 Ievels. Fixed and variable angle locking unicortical screws are provided in lengths of 12, 14, 16, and 18mm and diameters of 4mm and 4.5mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior cervical spine (C2-T1)
Indicated Patient Age Range
skeletally mature patients
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)
Mechanical performance attributes per ASTM F1717 were found to be substantially equivalent to those of predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PreView Anterior Cervical Plate (K062371), Sanacor CSLP (K030866), Synthes DOC VCSS (K982443), DePuy Spine C-Jaws Cervical Compression Mini Frame (K062181) Medicrea Technologies OSStaple Staple System (K061385), BioMedical Enterprises, Inc. Pioneer Anterior Cervical Plate System (K043066) Pioneer Surgical Technology Ant-Cer Dynamic Anterior Cervical Plate System (K024326) Spinal Concepts. Inc. Synthes Vectra-T System (K051665), Synthes Spine C3 Anterior Cervical Plate System (K012881)
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
KO73500
510(k) Summary
JUL - 3 2008
Submitter: Sanacor LLC Contact Person: Mr. Michael D. Ensign Sanacor LLC 765 E 340 S Suite 204 American Fork, UT 84003 Telephone: (801) 756-6249 Fax: (801) 756-8286 Date Prepared: March 13, 2008 Trade Name: Active Anterior Cervical Plate System Classification: Class II Classification Name: Appliance, fixation, spinal intervertebral body Number: 21 CFR 888.3060 Product Code: KWO Predicate Device(s): The subject device is substantially equivalent to the following systems which are currently marketed and distributed in the US: PreView Anterior Cervical Plate (K062371), Sanacor CSLP (K030866), Synthes DOC VCSS (K982443), DePuy Spine C-Jaws Cervical Compression Mini Frame (K062181) Medicrea Technologies OSStaple Staple System (K061385), BioMedical Enterprises, Inc. Pioneer Anterior Cervical Plate System (K043066) Pioneer Surgical Technology Ant-Cer Dynamic Anterior Cervical Plate System (K024326) Spinal Concepts. Inc. Synthes Vectra-T System (K051665), Synthes Spine C3 Anterior Cervical Plate System (K012881), Spine Vision
1
K073500
Page 2 of 2
Device Description: The Active " Anterior Cervical Plate System is a fixation system designed to allow for settling of the bone graft during fusion. Plates are provided in various lengths to accommodate fusions from 1 to 4 Ievels. Fixed and variable angle locking unicortical screws are provided in lengths of 12, 14, 16, and 18mm and diameters of 4mm and 4.5mm.
The Active™ Anterior Cervical Plate System is intended for the treatment Intended Use: of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implants after the attainment of a solid fusion mass. The Active "10 Anterior Cervical Plate System is intended for use under the following indications:
· Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Trauma (i.e., fracture or dislocation)
- · Spinal stenosis
· Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- · Pseudoarthrosis
- · Failed previous fusion
Basis of Substantial
Equivalence:
The Active Anterior Cervical Plate System is substantially equivalent to the above listed predicate devices.
The substantially equivalent technological characteristics found in the Active Anterior Cervical Plate System include the following:
- Augment stability of grafted segment PreView (K062371), CSLP (K030866)
- Segmented plate to allow screw translation via carriages DOC (K982443), Vectra (K051665), Ant-Cer (K024326)
- Combined use of two titanium alloys: Nitinol and Ti-6Al-4V Pioneer (K043066)
- Compression applied to bone graft OSStaple (K061385), C-JAWS (K062181), C3 (K012881)
All of these technologies are substantially equivalent to those found among the predicate devices.
Mechanical performance attributes per ASTM F1717 were found to be substantially equivalent to those of predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sanacor, LLC % Mr. Michael Ensign Regulatory Manager 765 East 340 South, Suite 204 American Fork, Utah 84003-3348
JUL - 8 2008
Re: K073500
Trade/Device Name: Active™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis. Regulatory Class: II Product Code: KWQ Dated: May 2, 2008 Received: May 5, 2008
Dear Mr. Ensign:
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 - Mr. Michael Ensign
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Active™ Anterior Cervical Plate System
Indications for Use:
The Active "10 Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-11) with removal of the implants after the attainment of a solid fusion mass. The Active ™ Anterior Cervical Plate System is intended for use under the following indications:
· Degenerative disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Trauma (i.e., fracture or dislocation)
- · Spinal stenosis
- · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
- · Failed previous fusion
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)
(Division Sign Off
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
K0031