CODA™ Anterior Cervical Plate System

K230993 · Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech · KWQ · Jun 20, 2023 · Orthopedic

Device Facts

• Record ID: K230993
• Device Name: CODA™ Anterior Cervical Plate System
• Applicant: Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 20, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CODA™ Anterior Cervical Plate System is intended for anterior cervical 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, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

CODA™ Anterior Cervical Plate System; spinal intervertebral body fixation orthosis. System comprises titanium alloy (Ti-6Al-4V ELI) plates and screws; integrated active locking mechanism; various lengths; constrained and variable screw options. Includes reusable and single-use instruments for implantation. Used in surgical settings by orthopedic or neurosurgeons for cervical spine stabilization. Subject of 510(k) is introduction of sterile-packaged implants. Device provides mechanical stability to cervical spine to facilitate fusion; benefits patient by addressing instability from trauma, degeneration, or deformity.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical testing regarding sterility and packaging configuration.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI). Components: Plates with integrated active locking mechanism, constrained/variable screws. Instruments: Reusable and single-use. Sterilization: Sterile and non-sterile configurations. Connectivity: None.

Indications for Use

Indicated for anterior cervical fixation (C2-C7) as an adjunct to fusion in skeletally mature patients with degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities/curvatures, tumor, pseudoarthrosis, or failed previous fusion.

Regulatory Classification

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.

Predicate Devices

• CODA™ Anterior Cervical Plate System (K222493)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech Alicia Kaufman Sr. Regulatory Affairs Specialist 375 River Park Circle Marquette, Michigan 49855

Re: K230993

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: KWQ Dated: May 23, 2023 Received: May 23, 2023

Dear Alicia 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

June 20, 2023

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Image /page/1/Picture/5 description: The image shows the name "Eileen Cadel -S" in large, bold font on the left side. To the right of the name, there is a digital signature block. The signature indicates that the document was digitally signed by Eileen Cadel -S on June 20, 2023, at 13:24:11 -04'00'.

for

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

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### Indications for Use

Submission Number (if known)

K230993

Device Name

CODA™ Anterior Cervical Plate System

#### Indications for Use (Describe)

The CODA™ Anterior Cervical Plate System is intended for anterior cervical 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, 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)

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| | | K230993 - Page 1 of 2 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------|
| | 510(k) Summary | Prepared on: 2023-05-02 |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Pioneer Surgical Technology, Inc. (D.B.A Resolve Surgical Technologies) | |
| Applicant Address | 375 River Park Circle Marquette MI 49855 United States | |
| Applicant Contact Telephone | 763-772-6137 | |
| Applicant Contact | Mrs. Alicia Kaufman | |
| Applicant Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | CODA™ Anterior Cervical Plate System | |
| Common Name | Spinal intervertebral body fixation orthosis | |
| Classification Name | Appliance, Fixation, Spinal Intervertebral Body | |
| Regulation Number | 888.3060 | |
| Product Code | KWQ | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K222493 | CODA™ Anterior Cervical Plate System | KWQ |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| 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 and sterile, single use 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 non-sterile, reusable instruments and sterile, single use instruments designed to facilitate proper implantation of the plate and screws. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |

The CODA™ Anterior Cervical Plate System is interior cervical 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 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.

## Indications for Use Comparison

The CODA™ Anterior Cervical Plate System indications included in this Special 510(k) are the same as the CODA™ Anterior Cervical Plate System indications cleared via K222493.

# Technological Comparison

The CODA™ Anterior Cervical Plate System was previously cleared via K222493. The purpose of this Special 510(k) is to introduce sterile implants to the CODA™ Anterior Cervical Plate System. Aside from the difference in sterility and packaging configuration, the subject device has the same technological characterice. The summary of verification and validation activities included

## 21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

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in this submission supports that the sterility and packaging configuration differences do not raise issues of safety and effectiveness as compared to the predicate device.

#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Testing was conducted to show that the introduction of a sterile packaged version of the CODA™ Anterior Cervical Plate System does not impact the safety or performance. Clinical data was not necessary for the determination of substantial equivalence. Therefore, the CODA™ Anterior Cervical Plate System is substantially equivalent to the predicate device.