LumiVy Lumbar IBF System

K212930 · Vy Spine, LLC · MAX · Feb 16, 2022 · Orthopedic

Device Facts

• Record ID: K212930
• Device Name: LumiVy Lumbar IBF System
• Applicant: Vy Spine, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Feb 16, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device, is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device is also 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 disease (DDD) with up to Grade 1 spondylolisthesss. 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 have had six months of non-operative treatment. Additional supplemental fixation is not necessary for the LumiVy™ -AS implants if the integrated screws are implanted.

Device Story

LumiVy Lumbar IBF System is an intervertebral spacer for the anterior lumbar spine; inserts between vertebral bodies to facilitate fusion. Used with autogenous bone graft. Implants consist of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers; may include Titanium alloy bone screws for fixation. Integrated screw version (LumiVy-AS) eliminates need for additional supplemental fixation. Device is implanted by surgeons in clinical settings. Benefits include stabilization of the spinal segment and promotion of fusion in patients with degenerative disc disease.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical testing and design comparison to the predicate device.

Technological Characteristics

Spacer made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers; optional Titanium alloy bone screws. No software or electrical components. Sterilization method not specified.

Indications for Use

Indicated for skeletally mature patients requiring intervertebral body fusion at one or two contiguous lumbar levels (L2-S1) for degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis, following six months 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

• Reliance Lumbar IBF (K183049)

Submission Summary (Full Text)

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February 16, 2022

Vy Spine™, LLC Jordan Hendrickson Operations Manager 2236 Capital Circle NE, Suite 103-1 Tallahassee, Florida 32308

Re: K212930

Trade/Device Name: LumiVy" Lumbar IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 17, 2021 Received: January 18, 2022

Dear Jordan Hendrickson:

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 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) K212930

Device Name Vy Spine™ LumiVyTM Lumbar IBF System

#### Indications for Use (Describe)

The Vy Spine™ LumiVyTM Lumbar IBF System, when used as an Intervertebral Body Fusion device, is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device is also 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 disease (DDD) with up to Grade 1 spondylolisthesss. 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 have had six months of non-operative treatment.

Additional supplemental fixation is not necessary for the LumiVy™ -AS implants if the integrated screws are implanted.

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

| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
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K212930 Page 1 of 2

#### 510(k) Summary

16 December 2021

Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee, FL 32308 Telephone: [phone] Fax:

Jordan Hendrickson Contact: Operations Manager

Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name: Regulation Number: Product Code: MAX

Intervertebral Body Fusion Device Vy Spine™ LumiVy™ Lumbar IBF System Class II, Intervertebral Body Fusion Device 21 CFR 888.3080

# Substantial Equivalence

The Vy Spine™ LumiVyTM Lumbar IBF System is substantially equivalent to the primary predicate device Reliance Lumbar IBF (K183049). The Vy Spine™ LumiVy™ Lumbar IBF System is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation.

### Device Description

The Vy Spine™ LumiVy™ Lumbar IBF System is comprised of implants components. The implant component, the Vy Spine™ LumiVy™ Lumbar IBF System device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Vy Spine™ LumiVy™ Lumbar IBF System may also include bone screws manufactured from Titanium alloy to secure the device to the vertebral body.

### Intended Use/Indications for Use

The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device, is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device is also 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 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 have had six months of non-operative treatment.

Additional supplemental fixation is not necessary for the LumiVy™ -AS implants if the integrated screws are implanted.

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# Non-Clinical Testing

The RELIANCE Lumbar IBF System (K183049) has undergone Non-Clinical Testing using various ASTM Standard tests at a third party facility. The subject Vy Spine™ LumiVyTM Lumbar IBF System has similar design, sizes, indication of use & biocompatibility as the predicate devices.

## Technological Modifications

The subject Vy Spine™ LumiVy™ Lumbar IBF System differs from the primary predicate devices in terms of additional sizes.

### Technological Characteristics

The subject Vy Spine™ Lumbar IBF 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 have equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.