XYPAN Expandable Lumbar Cage System

K203531 · Aegis Spine, Inc. · MAX · Jan 29, 2021 · Orthopedic

Device Facts

• Record ID: K203531
• Device Name: XYPAN Expandable Lumbar Cage System
• Applicant: Aegis Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jan 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

XYPAN Expandable Lumbar Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. XYPAN Expandable Lumbar Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Story

The XYPAN Expandable Lumbar Cage System consists of hollow, rectangular interbody fusion implants designed to facilitate spinal fusion. Implants are inserted in an unexpanded state and expanded in situ using system-specific instrumentation to restore disc height. Serrated superior and inferior surfaces provide fixation to vertebral endplates. The system is used by surgeons in spinal fusion procedures, requiring supplemental fixation and bone graft (autogenous or allogenous). Implants are available in various dimensions and lordotic angles to accommodate patient anatomy. Approaches include transforaminal/posterior (XYPAN-XT), anterior to psoas (XYPAN-XTP), and lateral (XYPAN-XL). The device provides structural support to the intervertebral space, promoting fusion and potentially alleviating discogenic back pain.

Clinical Evidence

No clinical data. Substantial equivalence is based on engineering rationales and mechanical performance comparisons to the predicate device.

Technological Characteristics

Constructed from Titanium 6AL-4V alloy (ASTM F136). Expandable, hollow, rectangular form factor with serrated surfaces. Mechanical expansion mechanism. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, including those with up to Grade 1 spondylolisthesis or retrolisthesis. Requires 6 months of prior 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

• AccelFix Lumbar Interbody Fusion Cage System (K190708)

Submission Summary (Full Text)

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January 29, 2021

Aegis Spine, Inc. Meredith Lee May, MS, RAC Director of Consulting Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K203531

Trade/Device Name: XYPAN Expandable Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 24, 2020 Received: December 2, 2020

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.

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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 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 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known) K203531 Device Name XYPAN Expandable Lumbar Cage System

Indications for Use (Describe)

XYPAN Expandable Lumbar Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. XYPAN Expandable Lumbar Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Type of Use (Select one or both, as applicable) [ ] Over-The-Counter Use (21 CFR 801 Subpart C) 区 Prescription Use (Part 21 CFR 801 Subpart D) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] "An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

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# 510(K) SUMMARY

| Submitter's Name: | Aegis Spine, Inc. |
|----------------------------|-----------------------------------------------------------------------------------------------|
| Submitter's Address: | 9781 S. Meridian Blvd, Ste 300<br>Englewood, CO 80112 |
| Submitter's Telephone: | +1.303.741.4123 |
| Contact Person: | Meredith Lee May MS, RAC<br>Empirical Testing Corp.<br>719.337.7579<br>[e-mail] |
| Date Summary was Prepared: | 24Nov2020 |
| Trade or Proprietary Name: | XYPAN Expandable Lumbar Cage System |
| Common or Usual Name: | intervertebral fusion device with bone graft, lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Orthopedics |

#### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The XYPAN Lumbar Expandable Cage System's implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.

- -XYPAN-XT Expandable Cage is to be implanted via transforaminal and posterior approach.
- -XYPAN-XTP Expandable Cage is to be implanted via Anterior to Psoas approach.
- XYPAN-XL Expandable Cage is to be implanted via lateral approach. -

#### INDICATIONS FOR USE

X YPAN Expandable Lumbar Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. XYPAN Expandable Lumbar Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

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## TECHNOLOGICAL CHARACTERISTICS

X YPAN Expandable Lumbar Cage System is made from Titanium 6AL-4V alloy that conforms to ASTM F136. The subject and predicate device have identical technological characteristics. Specifically, the following characteristics are identical between the subject and predicates:

- Indications for Use
- Materials of manufacture
- Structural support mechanism

#### Table 5-1 Predicate device

| 510k Number | Trade or Proprietary or Model<br>Name | Manufacturer | Predicate<br>Type |
|-------------|-------------------------------------------------|-------------------------|-------------------|
| K190708 | AccelFix Lumbar Interbody Fusion<br>Cage System | L&K Biomed Co.,<br>Ltd. | Primary |

# PERFORMANCE DATA

Engineering rationales and comparisons between the subject and predicate devices were used to leverage previously conducted performance testing.

## CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the XYPAN Expandable Lumbar Cage System is substantially equivalent to the predicate device.