Sypher Spacer System

K181337 · Biogennix, LLC · MAX · Sep 18, 2018 · Orthopedic

Device Facts

• Record ID: K181337
• Device Name: Sypher Spacer System
• Applicant: Biogennix, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Sep 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sypher Spacer System is a standalone intervertebral body fusion system for use in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous and/or allogenic bone graft (composed of cancellous and/or corticocancellous bone) at one or two contiguous levels of the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Supplemental fixation is required whenever fewer than 3 bone screws are utilized.

Device Story

Sypher Spacer System is a standalone intervertebral body fusion device for lumbar spine surgery. Implants consist of PEEK-OPTIMA cylinder blocks with tantalum markers and titanium alloy self-tapping/self-drilling bone screws with a cage lock assembly. Device features hollow center for autogenous/allogenic bone graft and surface teeth to prevent migration. Used by surgeons in clinical settings to treat degenerative disc disease. Implants are available in various footprints, heights, and lordotic angles. Supplemental fixation required if fewer than 3 screws are used. Device provides structural support to the intervertebral space to facilitate fusion.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing included static compression (ASTM F2077), static shear compression (ASTM F2077), and expulsion testing (ASTM Draft Standard F-04.25.02.02), supplemented by Finite Element Analysis.

Technological Characteristics

Cylinder-shaped PEEK-OPTIMA LT1 (ASTM F2026) blocks; tantalum markers (ASTM F560); titanium alloy (ASTM F136) self-tapping/self-drilling bone screws and cage lock assemblies. Features hollow center for bone graft and surface teeth. Available in various footprints, heights, and lordotic angles.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous lumbar levels (L2-S1), including Grade I spondylolisthesis or retrolisthesis, who failed six months of 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

• Biogennix Sypher Spacer System (K141798)

Reference Devices

• Zimmer Biomet Solitaire (K081395, K081501)
• Zimmer Biomet ROI-A® ALIF Cage System (K153495)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.

September 18, 2018

Biogennix, LLC % Daniel Johnson Regulatory Engineer JALEX Medical, LLC. 30311 Clemens Rd. Suite 5D Westlake, Ohio 44145

Re: K181337

Trade/Device Name: Sypher Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OVD Dated: August 21, 2018 Received: August 22, 2018

Dear Mr. Johnson:

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

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 mediation-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.

# Melissa Hall -S

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K181337

Device Name Sypher Spacer System

## Indications for Use (Describe)

The Sypher Spacer System is a standalone intervertebral body fusion system for use in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous and/or allogenic bone graft (composed of cancellous and/or corticocancellous bone) at one or two contiguous levels of the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Supplemental fixation is required whenever fewer than 3 bone screws are utilized.

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) | |

## 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 required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## K181337 510(k) Summary

| Submitted By: | Biogennix, LLC<br>18007 Sky Park Circle, Suite F<br>Irvine, CA 92614 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------|
| Date: | 08/21/2018 |
| Contact Person: | Daniel Johnson, Regulatory Engineer |
| Contact Telephone: | [phone] |
| Contact Fax: | [phone] |
| Device Trade Name: | Sypher Spacer System |
| Device Common Name: | Intervertebral Fusion Device |
| Device Classification Name: | Intervertebral Fusion Device With Bone Graft, Lumbar<br>Intervertebral Fusion Device With Integrated Fixation, Lumba |
| Regulation Number: | 21 CFR 888.3080 |
| Device Classification: | Class II |
| Product Code: | MAX, OVD |
| Primary Predicate: | Biogennix Sypher Spacer System (K141798)<br>The predicate device has never been subjected to a recall |
| Reference Predicates: | Zimmer Biomet Solitaire (K081395, K081501)<br>Zimmer Biomet ROI-A® ALIF Cage System (K153495) |

## Device Description:

The Sypher Spacer System is a standalone intervertebral body fusion system intended for the lumbar spine. The Sypher Spacer System implants include cylinder shaped blocks manufactured from PEEK-OPTIMA™ LT1 conforming to ASTM F2026, tantalum markers conforming to ASTM F560, titanium alloy self-tapping, self-drilling bone screws conforming to ASTM F136, and titanium alloy cage lock assemblies conforming to ASTM F136.

The implants are available in a variety of footprints. heights, and lordotic angles. The device features a hollow center to accommodate autogenous and/or allogenic bone graft (composed of cancellous and/or corticocancellous bone). The implants have integrated anterior screw holes to allow for medial placement of screws, and a titanium alloy cage lock assembly for securing the screws in place. The superior and inferior surfaces of the implant have a pattern of teeth to prevent movement.

### Indications For Use:

The Sypher Spacer System is a standalone intervertebral body fusion system for use in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous and/or allogenic bone graft (composed of cancellous and/or corticocancellous bone) at one or two contiguous levels of the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Supplemental fixation is required whenever fewer than 3 bone screws are utilized.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "BIOGENNiX" in a stylized, bold, sans-serif font. The letters are all capitalized and connected, with rounded corners. The "X" has a swoosh extending from the bottom left to the top right, adding a dynamic element to the logo. The overall design is modern and sleek.

## Summary of Technological Characteristics:

The Sypher Spacer System and the predicates have similar intended use and fundamental scientific technology. All devices compare similarly in:

- Design features
- Intended use ●
- Materials
- Dimensions
- Function

## Mechanical Testing:

Substantial Equivalence is supported by the results of mechanical testing and Finite Element Analysis (FEA). The mechanical testing performed includes static compression per ASTM F2077, static shear compression per ASTM F2077, and expulsion testing per ASTM Draft Standard F-04.25.02.02.

## Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate devices, the subject device has demonstrated substantial equivalence.