CervAlign™ Anterior Cervical Plate System

K183060 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · KWQ · Jan 17, 2019 · Orthopedic

Device Facts

• Record ID: K183060
• Device Name: CervAlign™ Anterior Cervical Plate System
• Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: 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, pseudarthrosis, and failed previous fusion.

Device Story

CervAlign Anterior Cervical Plate System provides temporary stabilization of cervical spine (C2-C7) to promote fusion. System comprises titanium alloy (Ti-6Al-4V ELI) plates and screws of varying sizes to accommodate patient anatomy. Plates feature integrated cover-style locking mechanisms to secure screws. Used by surgeons in clinical settings to treat degenerative disc disease, trauma, deformities, and other spinal pathologies. Device provides resistance to flexion, extension, lateral bending, and axial rotation. Implants are provided non-sterile and require sterilization before use. System includes dedicated instrumentation for insertion and removal.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via ASTM F1717-18 static/dynamic compression bending and static torsion. Locking mechanism retention tested. MR safety evaluated per ASTM F2052-15, F2213-17, F2182-11a, and F2119-07. All tests met established acceptance criteria.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V ELI). Components: Plates with integrated cover-style locking mechanisms and screws. Standards: ASTM F1717-18 (mechanical), ASTM F2052-15, F2213-17, F2182-11a, F2119-07 (MR safety). Non-sterile; requires sterilization. Mechanical principle: Rigid fixation for spinal stabilization.

Indications for Use

Indicated for patients requiring anterior cervical fixation (C2-C7) due to degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis/lordosis/kyphosis), tumor, pseudarthrosis, 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

• Pioneer Aspect Anterior Cervical Plate System (K130427)
• Pioneer Anterior Cervical Plate System (PACP) (K083663)

Submission Summary (Full Text)

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January 17, 2019

Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Ms. Jaclyn Holli Specialist, Regulatory Affairs 375 River Park Circle Marquette, Michigan 49855

Re: K183060

Trade/Device Name: CervAlign™ 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: November 1. 2018 Received: November 2, 2018

Dear Ms. Holli:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Ronald P. Jean -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

K183060

Device Name CervAlign™ Anterior Cervical Plate System

#### Indications for Use (Describe)

The CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: 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, pseudarthrosis, 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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## 510(k) Summary

## As required by 21 CFR 807.92

| Company: | Pioneer Surgical Technology, Inc.<br>DBA RTI Surgical, Inc.<br><br>375 River Park Circle<br>Marquette, MI 49855 USA<br>Phone: [phone]<br>Fax: [phone]<br>Prepared: November 1, 2018 |
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| Submitter/Contact: | Jaclyn Holli<br>Specialist, Regulatory Affairs<br>RTI Surgical, Inc.<br>[e-mail]<br>[phone] ext. 5647 |
| Trade name: | CervAlign™ Anterior Cervical Plate System |
| Common name: | Anterior Cervical Plate System |
| Classification: | Class II; 21 CFR 888.3060 (Product Code KWQ –<br>Appliance, Fixation, Spinal Intervertebral Body) |
| Panel: | Orthopedic Device Panel |
| Predicates: | Primary Predicate:<br>Pioneer Aspect Anterior Cervical Plate System (K130427<br>cleared 6/5/2013)- Pioneer Surgical Technology, Inc.<br><br>Additional Predicate:<br>Pioneer Anterior Cervical Plate System (PACP) (K083663<br>cleared 2/25/2009)- Pioneer Surgical Technology, Inc. |
| Description: | The CervAlign Anterior Cervical Plate System is designed<br>to promote cervical fusion by providing temporary<br>resistance to flexion, extension, lateral bending, and axial<br>rotation with strength and stiffness in the cervical spine<br>(C2-C7). The system includes implants of various sizes of<br>screws and plates to accommodate varying patient<br>anatomies. The plates have integrated cover-style locking<br>mechanisms that actuate to cover each screw. Implants<br>are manufactured from titanium alloy, Ti-6Al-4V ELI |
| | instrumentation necessary to facilitate the insertion and<br>removal. |
| | The implants and instruments are provided non-sterile and<br>must be sterilized before use. Sterilization cases and trays<br>are provided to facilitate proper sterilization and storage. |
| Indications for<br>Use: | The CervAlign Anterior Cervical Plate System is intended<br>for anterior cervical fixation (C2-C7) for the following<br>conditions: degenerative disc disease (DDD) defined as<br>neck pain of discogenic origin with degeneration of the<br>disc confirmed by history and radiographic studies,<br>spondylolisthesis, trauma (i.e., fracture or dislocation),<br>spinal stenosis, deformities or curvatures (i.e., scoliosis,<br>kyphosis, and/or lordosis), tumor, pseudarthrosis, and<br>failed previous fusion. |
| Summary of<br>Technological<br>Characteristics: | The subject system has the same or similar fundamental<br>technology (technological characteristics, indications for<br>use, material, principles of operation, overall implant<br>geometry and size options, and anatomical location of<br>use) as the predicates. |
| Discussion of<br>Supporting Non-<br>Clinical Testing: | The following nonclinical tests were submitted and relied<br>on in this premarket notification submission for a<br>determination of substantial equivalence. Testing<br>identified in this summary has all passed acceptance<br>criteria established by the predicate device, where<br>applicable. Performance testing showed that the<br>mechanical strength of the subject system is equivalent to<br>or better than predicate devices and is therefore sufficient<br>for the intended use. |
| | Mechanical Testing:<br>ASTM F1717-18 static and dynamic compression<br>bending ASTM F1717-18 static torsion Locking Mechanism Retention Other modes of mechanical testing were evaluated via an<br>engineering rationale, but not required nor completed for a<br>determination of substantial equivalence. |
| | MR Safety Evaluation determined the devices are MR<br>Conditional via the following standards:<br>ASTM F2052-15, "Standard Test Method for<br>Measurement of Magnetically Induced |
| | Displacement Force on Medical Devices in the<br>Magnetic Resonance Environment" ASTM F2213-17, "Standard Test Method for<br>Measurement of Magnetically Induced Torque on<br>Medical Devices in the Magnetic Resonance<br>Environment" ASTM F2182-11a, “Standard Test Method for<br>Measurement of Radio Frequency Induced Heating<br>Near Passive Implants During Magnetic<br>Resonance Imaging" ASTM F2119-07 (Reapproved 2013), “Standard<br>Test Method for Evaluation of MR Image Artifacts<br>from Passive Implants" |
| Conclusion: | The supporting evidence in this submission is sufficient<br>to justify the substantial equivalence of the subject<br>CervAlign Anterior Cervical Plate System as compared<br>to the predicate devices referenced. |

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