(92 days)
Not Found
No
The 510(k) summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "adjunct to fusion" for various spinal conditions, indicating its role in treating or alleviating a medical condition by providing structural support for the cervical spine.
No
The device description clearly states its purpose as an "Anterior Cervical Plate (ACP) System" for "anterior fixation of the cervical spine... as an adjunct to fusion." It is comprised of "plates and screws," which are used in surgery to stabilize the spine, not to diagnose conditions.
No
The device description explicitly states the system consists of non-sterile plates and screws manufactured from titanium alloy, and includes nonsterile, reusable instruments and sterile, single use instruments. These are physical hardware components, 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The CODA Anterior Cervical Plate System is a surgical implant used for anterior fixation of the cervical spine. It is a physical device implanted into the body.
- Intended Use: The intended use is for surgical stabilization of the cervical spine as an adjunct to fusion. This is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant and its intended use in a surgical setting, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CODA Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: 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., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes
KWO, KWQ
Device Description
The CODA™ Anterior Cervical Plate (ACP) System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile plates and screws that are manufactured from titanium alloy (Ti-6Al-4V ELI). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes nonsterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws.
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
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)
The following mechanical tests were performed on the subject device: static compression bending per ASTM F1717, torsional static testing per ASTM F1717, and dynamic compression bending per ASTM F1717. Results indicate that the subject device performed as well or better than legally marketed predicate devices.
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
November 18, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Pioneer Surgical Technology, Inc. (D.B.A. Resolve Surgical Technologies) Ms. Alicia Kaufman Sr. Regulatory Affairs Specialist 375 River Park Circle Marquette, Michigan 49855-0627
Re: K222493
Trade/Device Name: CODA™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: October 18, 2022 Received: October 18, 2022
Dear Ms. Kaufman:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222493
Device Name CODATM Anterior Cervical Plate System
Indications for Use (Describe)
The CODA Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion is skeletally mature patients. Specific indications include: 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., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for Resolve Surgical Technologies. The logo consists of two curved shapes in blue and dark blue on the left side. To the right of the shapes, the word "RESOLVE" is written in large, bold, dark blue letters. Below the word "RESOLVE", the words "SURGICAL TECHNOLOGIES" are written in smaller, light blue letters.
510(k) S
As required by 21CFR807
| Sponsor | Pioneer Surgical Technology, Inc. (D.B.A Resolve Surgical Technologies)
375 River Park Circle
Marquette, MI 49855
+1 800-557-9909 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| | Alicia Kaufman
akaufman@resolvesurg.com
+1 763-772-6137 |
| Contact | Alternate contact:
John White
jjwhite@resolvesurg.com
+1 906-361-6589 |
| Date Prepared | August 17, 2022 |
| Proprietary Name | CODA™ Anterior Cervical Plate System |
| Common Name | Anterior Cervical Plate System |
| Classification Name | Appliance, Fixation, Spinal Intervertebral Body |
| Classification | Class: 2
Regulation Number: 21 CFR 888.3060 (Spinal intervertebral body fixation
orthosis)
Product Code: KWQ |
| Predicate Device | Primary predicate: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM (K103494,
888.3060, KWQ) |
Device Description
The CODA™ Anterior Cervical Plate (ACP) System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile plates and screws that are manufactured from titanium alloy (Ti-6Al-4V ELI). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes nonsterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws.
Intended Use/Indications for Use
The CODA Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: 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., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
4
Image /page/4/Picture/1 description: The image shows the logo for Resolve Surgical Technologies. The logo consists of two curved shapes in blue and dark blue on the left side. To the right of the shapes, the word "RESOLVE" is written in large, bold, dark blue letters, and below it, the words "SURGICAL TECHNOLOGIES" are written in smaller, light blue letters.
Technological Characteristics
The CODA Anterior Cervical Plate System has the same or similar technological characteristics (design, materials, principles of operation, indications for use) as the primary predicate, SKYLINE ANTERIOR CERVICAL PLATE SYSTEM.
Non-Clinical Performance Data
The following mechanical tests were performed on the subject device: static compression bending per ASTM F1717, torsional static testing per ASTM F1717, and dynamic compression bending per ASTM F1717. Results indicate that the subject device performed as well or better than legally marketed predicate devices.
Conclusion
The information provided demonstrates that the CODA™ Anterior Cervical Plate System is substantially equivalent to legally marketed predicate devices.