Curiteva Porous PEEK Cervical Interbody Fusion System

K213030 · Curiteva, Inc. · ODP · Feb 13, 2023 · Orthopedic

Device Facts

• Record ID: K213030
• Device Name: Curiteva Porous PEEK Cervical Interbody Fusion System
• Applicant: Curiteva, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Feb 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Device Story

Interbody fusion system consisting of sterile, single-use, box-shaped implants; designed for anterior cervical spine surgery. Implants feature open central corridor for bone graft packing; porous PEEK structure on superior/inferior surfaces and graft corridor; hydroxyapatite (HA) surface coating. Used by surgeons in clinical settings to stabilize spine segments; requires supplemental fixation. Implants accommodate varying patient anatomy; facilitate fusion via autogenous/allogeneic bone graft. Benefits include spinal stabilization and symptom relief for degenerative conditions.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing including axial compression, compression-shear, torsion (ASTM F2077), subsidence (ASTM F2267), wear debris characterization (ASTM F1877), expulsion, and impaction testing.

Technological Characteristics

Implant-grade PEEK (ASTM F2026) with Titanium alloy markers (ASTM F136). Features porous PEEK structure and 20nm thick hydroxyapatite (HA) coating. Sterile, single-use, box-shaped form factor. No software or energy source.

Indications for Use

Indicated for skeletally mature patients with cervical disc degeneration and/or cervical spinal instability resulting in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. Requires use with supplemental fixation and bone graft.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Curiteva Cervical Interbody Fusion System (K181261)
• Astura Medical ALTA Anterior Cervical Interbody Spacer (K173324)
• Cutting Edge Spine, LLC EVOL SI Joint Fusion System (K190025)

Submission Summary (Full Text)

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February 13, 2023

Curiteva, Inc. % Meredith May, MS, RAC Director of Consulting Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K213030

Trade/Device Name: Curiteva Porous PEEK Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: January 11, 2023 Received: January 11, 2023

Dear Ms. May:

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

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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 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,

Brent Showalter -S

Brent Showalter, Ph.D. 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

510(k) Number (if known) K213030

#### Device Name

Curiteva Porous PEEK Cervical Interbody Fusion System

Indications for Use (Describe)

The Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary - K213030

#### A. Submitter Information

| Submitter: | Curiteva, Inc.<br>25127 Will McComb Drive, Suite 100<br>Tanner, AL 35671<br>Phone: [phone]<br>Fax: [phone] |
|---------------------|--------------------------------------------------------------------------------------------------------------------------|
| Submitter Contact: | Eric Linder<br>Chief Technology Officer |
| Regulatory Contact: | Meredith May MS, RAC<br>Empirical Testing Corp.<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | February 9, 2023 |

#### B. Device Information

| Trade Name: | Curiteva Porous PEEK Cervical Interbody Fusion System |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device Classification: | Class II (per 21 CFR 888.3080) |
| Product Code: | ODP |
| Classification Panel: | Division of Orthopedic Devices |
| Predicate Device(s): | Primary: Curiteva Cervical Interbody Fusion System – K181261<br>Additional: Astura Medical ALTA Anterior Cervical Interbody<br>Spacer - K173324<br>Additional: Cutting Edge Spine, LLC EVOL SI Joint Fusion<br>System - K190025 |

#### C. Device Description

The Curiteva Porous PEEK Cervical Interbody Fusion System implants are sterile, single-use devices and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally boxshaped with an open central corridor to permit packing with bone graft to facilitate fusion. The implants have a dense central ring with a porous structure lining the vertical graft corridor and on

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the superior and inferior surfaces of the construct. Each implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.

The Curiteva Porous PEEK Cervical Interbody Fusion System implants are manufactured from implant-grade PEEK (per ASTM F2026) with Titanium alloy markers (per ASTM F136).

## D. Indications for Use

The Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT. MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

### E. Comparison of Technological Characteristics

As was established in this submission, the subject Curiteva Porous PEEK Cervical Interbody Fusion System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and to have similar technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

## F. Performance Data

Non-clinical testing performed on the Curiteva Porous PEEK Cervical Interbody Fusion System supports substantial equivalence to predicate devices. The following testing was performed:

- Axial compression per ASTM F2077
- Compression-shear per ASTM F2077 ●
- Torsion per ASTM F2077 ●
- Subsidence per ASTM F2267
- Wear debris characterization per ASTM F1877

Additional testing (e.g. expulsion, impaction) was performed to further support substantial equivalence. The results of non-clinical testing demonstrate that the strength and performance of the Curiteva Porous PEEK Cervical Interbody Fusion System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

#### G. Conclusion

Based on the indications for use, technological characteristics, non-clinical performance testing, and comparison to predicate devices, the subject Curiteva Porous PEEK Cervical Interbody Fusion System has been shown to be substantially equivalent to legally marketed predicate devices.