Vy Spine™ VyLam™ Laminoplasty System

K232471 · Vy Spine, LLC · NQW · Oct 10, 2023 · Orthopedic

Device Facts

• Record ID: K232471
• Device Name: Vy Spine™ VyLam™ Laminoplasty System
• Applicant: Vy Spine, LLC
• Product Code: NQW · Orthopedic
• Decision Date: Oct 10, 2023
• Decision: SESE
• Submission Type: Traditional
• 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

VyLam™ Laminoplasty System consists of titanium alloy plates and screws used to maintain spinal decompression following laminoplasty. Device implanted during surgery to secure allogenic bone graft in lower cervical/upper thoracic vertebrae (C3-T3). Prevents graft migration or spinal cord impingement. Operated by surgeons in clinical/OR settings. Provides mechanical fixation to stabilize vertebral anatomy post-decompression.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing: static and dynamic four-point bend testing (ASTM F2193) and axial pullout testing (ASTM F543) on worst-case constructs.

Technological Characteristics

Implant components: Ti-6Al-4V ELI (ASTM F136). Instruments: stainless steel (ASTM F899), high-grade plastic, silicone rubber. Mechanical fixation system. No software or electronic components.

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

• Synthes ARCH Fixation System (K032534)
• Gallery Laminoplasty System (K100805)

Submission Summary (Full Text)

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October 10, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

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

Re: K232471

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: NQW Dated: August 16, 2023 Received: August 16, 2023

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" (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).

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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 QS 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.

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).

Sincerely,

Eileen
Digitally signed
by Eileen Cadel
-
S
Cadel -S Date: 2023.10.10
09:23:35 -04'00'
for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K232471

#### 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) | |
|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

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

Contact: Jordan Hendrickson, Operations Manager 510(k) Number: K232471 Common or Usual Name: Interlaminal Fixation Appliance Proposed Proprietary or Trade Name: Vy Spine™ Laminoplasty System Classification Name: Spinal Interlaminal Fixation Orthosis Regulation Number: 21 CFR 888.3050 Product Code: NOW Primary Predicate: Synthes ARCH Fixation System (K032534) Additional Predicate: Gallery Laminoplasty System (K100805)

## Substantial Equivalence:

The subject Vy Spine™ VyLam™ Laminoplasty System is substantially equivalent to the legally marketed predicate devices, the Synthes ARCH Fixation System (K032534) and the Gallery Laminoplasty System (K100805). The subject Vy Spine™ Laminoplasty System is equivalent to its commercially available predicates in terms of intended use, indications for use, design, function, principle of operation, materials, size range, and strength.

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

## Intended Use / 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.

28 September 2023

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#### Performance Data and Substantial Equivalence:

The following mechanical testing was conducted: static four-point bend testing per ASTM F2193, dynamic four-point bend testing per ASTM F2193, and axial pullout testing per ASTM F543. The performance data indicates that the subject device is substantially equivalent to predicate devices and has met all mechanical test requirements based on worst-case construct testing and the engineering rationale.