Vy Spine™ VyLam™ Laminoplasty System

K242784 · Vy Spine, LLC · NQW · Oct 16, 2024 · Orthopedic

Device Facts

• Record ID: K242784
• Device Name: Vy Spine™ VyLam™ Laminoplasty System
• Applicant: Vy Spine, LLC
• Product Code: NQW · Orthopedic
• Decision Date: Oct 16, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.

Device Story

The Vy Spine™ VyLam™ Laminoplasty System consists of implantable plates and screws used to stabilize the spine following a laminoplasty procedure. The system is designed to hold decompression by securing allogenic bone grafts, preventing graft expulsion or impingement on the spinal cord. The device is used by surgeons in a clinical/OR setting. The system is expanded to include new plate designs (Double Hook, Inline Double Hook, and Support Plates) to accommodate various vertebral anatomies. The implants are fixed to the vertebrae to maintain structural integrity post-decompression, providing mechanical support to the spinal column.

Clinical Evidence

Bench testing only. FEA analyses were performed to evaluate the mechanical strength of the additional plates compared to the predicate system plates using ASTM F2193 four-point bending standards.

Technological Characteristics

Implant components manufactured from Ti-6Al-4V ELI (ASTM F136). Instruments manufactured from stainless steel (ASTM F899), high-grade plastic, and silicone rubber. System includes plates and screws in various anatomical sizes. Mechanical testing performed per ASTM F2193.

Indications for Use

Indicated for laminoplasty of lower cervical and upper thoracic spine (C3-T3) in skeletally mature patients. Used with allogenic bone graft to prevent graft expulsion or spinal cord impingement.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Vy Spine™ VyLam™ Laminoplasty System (K232471)
• CENTERPIECE™ Plate Fixation System (K050082)

Submission Summary (Full Text)

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October 16, 2024

Vy Spine, LLC Jordan Hendrickson Quality Operations Manager 545 W 500 South, Suite 100 Bountiful. Utah 84011

Re: K242784

Trade/Device Name: Vy Spine™ VyLam™ Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NOW Dated: September 16, 2024 Received: September 16, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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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) K242784

#### Device Name

Vy Spine™ VyLam™ Laminoplasty System

#### Indications for Use (Describe)

The Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.

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

| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary

Vy Spine, LLC 545 W 500 South Suite 100 Bountiful, UT 84010 Telephone: [phone] Fax: [phone]

16 October 2024

Contact: Jordan Hendrickson, Operations Manager

| Common or Usual Name: | Interlaminal Fixation Appliance |
|-------------------------------------|---------------------------------------------------|
| Proposed Proprietary or Trade Name: | Vy Spine™ VyLam™ Laminoplasty System |
| Classification Name: | Spinal Interlaminal Fixation Orthosis |
| Regulation Number: | 21 CFR 888.3050 |
| Product Code: | NQW |
| Primary Predicate: | Vy Spine™ VyLam™ Laminoplasty System<br>(K232471) |
| Additional Predicate: | CENTERPIECE™ Plate Fixation System<br>(K050082) |

## Substantial Equivalence:

The subject Vy Spine™ VyLam™ Laminoplasty System is substantially equivalent to the primary predicate Vy Spine™ VyLam™ Laminoplasty System (K232471) and the additional predicate CENTERPIECE™ Plate Fixation System (K050082) in terms of intended use, indications for use, function, principle of operation, materials, size range, and strength.

## Purpose:

The purpose of this Special 510(k) submission is for the addition of implant plates to the Vy Spine™ VyLam™ Laminoplasty System. These additional plates include: VyLam™ Double Hook Plate, VyLam™ Inline Double Hook Plate, and VyLam™ Support Plate.

## Device Description:

The Vy Spine™ VyLam™ Laminoplasty System is comprised of implant and instrument components. The implant components, plates and screws, will hold the decompression after a laminoplasty procedure. The implant components are manufactured from Ti-6Al-4V ELI per ASTM F136 and are available in multiple anatomical sizes to accommodate various vertebral

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bodies. The instruments are manufactured from stainless steel per ASTM F899, high grade plastic, and silicone rubber.

# Indications for Use:

The Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.

## Technological Modifications:

The subject Vy Spine™ VyLam™ Laminoplasty System's technological characteristics are the same as or similar to the predicate devices commercially distributed.

# Performance Data and Substantial Equivalence:

FEA analyses for the additional plates' four-point bending (based on ASTM F2193) were performed to compare the strength of the additional plates to the standard plate in the predicate Vy Spine™ VyLam™ Laminoplasty System (K232471). The performance data verifies that the subject is substantially equivalent to the predicate Vy Spine™ Laminoplasty System (K232471).