Manta Ray TDF Spacer

K220296 · SeaSpine Orthopedics Corporation · ODP · Feb 3, 2023 · Orthopedic

Device Facts

• Record ID: K220296
• Device Name: Manta Ray TDF Spacer
• Applicant: SeaSpine Orthopedics Corporation
• Product Code: ODP · Orthopedic
• Decision Date: Feb 3, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Manta Ray TDF Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Manta Ray TDF Spacer is intended for use with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

Device Story

Cervical interbody fusion cage; engages disc space and uncovertebral joints to reduce subsidence; increases mating surface area. Used in spinal surgery; implanted by surgeons. Features central graft window for autograft/allograft bone. Provided sterile. Requires supplemental fixation. Benefits patient by facilitating fusion in DDD cases.

Clinical Evidence

No clinical data. Substantial equivalence based on non-clinical mechanical testing (static/dynamic compression, torsion, and subsidence) per ASTM standards.

Technological Characteristics

Interbody cage; PEEK (ASTM F2026); tantalum markers (ASTM F560); NanoMetalene (1-micron commercially pure titanium, ASTM F67) surface layer. Sterile. Various footprints and lordotic angles.

Indications for Use

Indicated for skeletally mature patients with cervical (C3-T1) degenerative disc disease (DDD) at multiple contiguous levels, confirmed by history and radiography, following at least 6 weeks of failed non-operative treatment.

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

• Shoreline Cervical Interbody RT System (K183083)
• SeaSpine WaveForm C Interbody System (K212904)
• Vu cPOD Intervertebral Body Fusion Device (K101363)
• Latitude-C Cervical Interbody Spacer System (K151496)

Submission Summary (Full Text)

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February 3, 2023

SeaSpine Orthopedics Corporation Ms. Jesse Albright Associate Manager, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008

Re: K220296

Trade/Device Name: Manta Ray TDF Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 23, 2023 Received: January 24, 2023

Dear Ms. Albright:

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) K220296

Device Name Manta Ray TDF Spacer

#### Indications for Use (Describe)

The Manta Ray TDF Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.

The Manta Ray TDF Spacer is intended for use with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

## Contact Details

Device Class:

| Applicant Name:<br>Address:<br>Phone number:<br>Fax number:<br>Contact Person:<br>Date Prepared: | SeaSpine Orthopedics Corporation<br>5770 Armada Drive, Carlsbad, CA 92008<br>[phone]<br>[phone]<br>Jesse Albright, Associate Manager, Regulatory Affairs<br>February 1, 2023 |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | |
| Trade Name:<br>Common Name:<br>Classification Name:<br>Product Code(s): | Manta Ray TDF Spacer<br>Intervertebral Body Fusion Device<br>Intervertebral Fusion Device With Bone Graft, Cervical (21 CFR 888.3080)<br>ODP |

### Legally Marketed Predicate Devices

2

| 510(k) Number | Product Code(s) | Trade Name | Manufacturer | |
|--------------------------------|-----------------|------------------------------------------------|-------------------------------------|--|
| Primary Predicate Device | | | | |
| K183083 | OVE, ODP | Shoreline Cervical<br>Interbody RT System | SeaSpine Orthopedics<br>Corporation | |
| Additional Predicate Device(s) | | | | |
| K212904 | OVE, ODP | SeaSpine WaveForm C<br>Interbody System | SeaSpine Orthopedics<br>Corporation | |
| K101363 | ODP | Vu cPOD Intervertebral<br>Body Fusion Device | SeaSpine Orthopedics<br>Corporation | |
| K151496 | ODP | Latitude-C Cervical<br>Interbody Spacer System | DeGen Medical | |

## Device Description

The Manta Ray TDF Spacer features a cervical interbody cage that engages the entire disc space, including the uncovertebral joints, during the fusion process. This engagement between the lateral wings and the uncovertebral joints is intended to further reduce subsidence by increasing the mating surface area. The interbody spacer is manufactured from polyetheretherketone (PEEK) (per ASTM F2026), tantalum (per ASTM F560) markers for radiographic visualization, and NanoMetalene®, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. Each spacer has a central graft window for receiving autograft and/or

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allogenic bone graft material and is offered in a variety of footprints, and lordotic options to accommodate variations in pathology and patient anatomy. The Manta Ray TDF Spacer is intended for use with supplemental fixation.

The instruments provided with the Manta Ray TDF Spacer facilitate the placement, adjustment, and removal, if necessary, of the interbody spacer. The spacer is provided sterile packaged, whereas the instruments are provided in system-specific trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

### Intended Use/Indications for Use

The Manta Ray TDF Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.

The Manta Ray TDF Spacer is intended for use with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

### Summary of Technological Characteristics

The Manta Ray TDF Spacer and the cited predicate devices have the same operational principle; they act as a disc spacer and hold bone graft. The subject device is also similar to the cited predicate devices in regard to intended use/indications for use, device description, technological characteristics (e.g., design, components, materials, manufacturing, labeling, sterility, etc.), and non-clinical performance (i.e., mechanical testing).

Compared to the predicate counterparts, the Manta Ray TDF Spacer is used to treat the same conditions, has essentially the same precautions and contraindications for use, and represents a basic design concept in terms of safety and effectiveness, differing only in design details and not functionality.

The subject and predicate devices are based on the following similar technological elements:

- . Spacer Heights
- Spacer Footprints
- . Spacer Lordotic Angles

#### Non-Clinical Testing

The Manta Ray TDF Spacer has demonstrated equivalent mechanical performance to the predicate devices through mechanical testing in static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, and subsidence per ASTM F2267.

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# Clinical Testing

Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.

## Conclusions

The submitted data demonstrate that the Manta Ray TDF Spacer is substantially equivalent to the cited legally marketed predicates.