Pantheon IBFD

K203003 · Pantheon Spinal · MAX · Jul 7, 2021 · Orthopedic

Device Facts

• Record ID: K203003
• Device Name: Pantheon IBFD
• Applicant: Pantheon Spinal
• Product Code: MAX · Orthopedic
• Decision Date: Jul 7, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as an intervertebral fusion device, the Pantheon IBFD devices are intended for use as either one level or two contiguous levels in the lumbar spine from L2 to S1, for the treatment of treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who are skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the devices are intended for use with supplemental fixation cleared for use in the lumbar spine and with autograft to facilitate fusion.

Device Story

Pantheon IBFD is an intervertebral body fusion device used in lumbar spinal fusion surgery. The device is oval-shaped with internal openings for bone graft and pyramidal teeth on inferior surfaces for fixation. Tantalum markers allow radiographic visualization of implant position; an articulating hub facilitates adjustable angulation during insertion. Surgeons implant the device into the disc space to promote fusion. The device is used in clinical settings by orthopedic or neurosurgeons. It acts as a structural spacer to restore disc height and stabilize the spinal segment while autograft facilitates biological fusion. The system includes various sizes, including 20-degree hyperlordotic options, to accommodate patient anatomy. Benefits include stabilization of the spinal segment and potential relief of discogenic back pain.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including ASTM F2077 static and dynamic compression tests, and Finite Element Analysis (FEA) to validate the new hyperlordotic size configurations.

Technological Characteristics

Materials: PEEK (ASTM F2026) and Ti6Al4V titanium alloy with tantalum markers (ASTM F136). Design: Oval shape, pyramidal teeth, articulating hub for inserter shaft. Connectivity: None. Energy: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis at one or two contiguous lumbar levels (L2-S1). Requires six months of failed non-operative treatment. Suitable for patients with prior non-fusion spinal surgery at the target level. Must be used with supplemental fixation and autograft.

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

• Pantheon Spinal Interbody Fusion Device (K181548)
• Pantheon Spinal Interbody Fusion Device (K113781)
• Titan Spine Endoskeleton TL Hyperlordotic Interbody Fusion Device (K191581)

Submission Summary (Full Text)

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July 7, 2021

Pantheon Spinal Dave Lamb Ouality and Regulatory Affairs 40132 Industrial Park Circle Suite 101 Georgetown, Texas 78626

Re: K203003

Trade/Device Name: Pantheon IBFD Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 9, 2021 Received: June 10, 2021

Dear Mr. Lamb:

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

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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 (OS) 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 mediation-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 L. 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) K203003

Device Name Pantheon IBFD

#### Indications for Use (Describe)

When used as an intervertebral fusion device, the Pantheon IBFD devices are intended for use as either one level or two contiguous levels in the lumbar spine from L2 to S1, for the treatment of treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who are skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the devices are intended for use with supplemental fixation cleared for use in the lumbar spine and with autograft to facilitate fusion.

**Type of Use (Select one or both, as applicable)**

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summarv

| Date: | July 6, 2021 |
|----------------------------|------------------------------------------------------------------------------|
| Sponsor: | Pantheon Spinal |
| | 40132 Industrial Park Circle Suite |
| | 101 Georgetown, TX 78626 |
| | 512-308-3488 |
| Establishment Registration | 3010665091 |
| Sponsor Contact: | Dave Lamb |
| Proposed Trade Name: | Pantheon IBFD |
| Common Name: | Interbody Fusion System |
| Device Classification: | Class II |
| Regulation Name | Intervertebral fusion device |
| Product Code | MAX |
| Regulation Number | 888.3080 |
| Primary Predicate: | Pantheon Spinal Interbody Fusion Device K181548, K113781 |
| Additional Predicates | Titan Spine Endoskeleton TL Hyperlordotic Interbody Fusion Device<br>K191581 |

Device Description: The Pantheon IBFD is oval in shape with one or more openings through the structure. Pyramidal teeth are incorporated on the inferior surfaces of each device. Tantalum markers provide visual feedback with respect to the invivo implant position. An articulating hub provides adjustable angulation of the device with respect to the inserter shaft. The devices are available in a variety of sizes to accommodate differing anatomic requirements. The device is manufactured from medical grade PEEK in accordance with ASTM F2026 and Ti6Al4V titanium alloy with tantalum markers conforming to ASTM F136. The subject device introduces the 20 degree hyperlordotic sizes in a variety of lengths, widths and heights.

Indications for use: When used as an intervertebral fusion device, the Pantheon IBFD devices are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc

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disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who are skeletally mature and have had six months of non- operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. The devices are intended for use with supplemental fixation cleared for use in the lumbar spine and with autograft to facilitate fusion.

Substantial Equivalence: The Pantheon IBFD is substantially equivalent to the primary predicate Pantheon Spinal Interbody Fusion Device (K181548) with respect to design, function, intended use, and materials with the exception of the proposed additional sizes.

Pantheon Spinal Interbody Fusion Device K181548 and additional (secondary) predicate Titan Spine Endoskeleton TL Hyperlordotic Interbody Fusion Device K191581 are similar in design,materials, and indications. The new Pantheon IBFD does not raise new questions about safety and effectiveness.

Performance Testing: New ASTM F2077 static and dynamic compression tests were performed to validate changes to the device. An FEA was created to verify that a new worse case was not created with the new size additions.

Conclusion: Based on information contained in this submission, and the similarities of the subject and predicate devices, the subject IBFD Interbody Fusion System is substantially equivalent to the predicate devices.