VUSION CS PLUS

K122588 · Ortho Development Corp. · ODP · Jun 12, 2013 · Orthopedic

Device Facts

• Record ID: K122588
• Device Name: VUSION CS PLUS
• Applicant: Ortho Development Corp.
• Product Code: ODP · Orthopedic
• Decision Date: Jun 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vusion® CS Plus device is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.

Device Story

Vusion® CS Plus is a cervical intervertebral body fusion device; implanted via open anterior approach; packed with autogenous bone; used with supplemental internal fixation. Device consists of PEEK Optima LT1 implant body with tantalum marker pins; features fixation teeth, graft window, and insertion hole. Available in various footprints, lordotic angles, and heights to match patient anatomy. Used by surgeons in clinical settings to facilitate spinal fusion in patients with degenerative disc disease.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static and dynamic compression, static shear, static and dynamic torsion, and subsidence testing per ASTM F2077 and ASTM F2267. Results demonstrate performance equivalent or superior to predicate devices.

Technological Characteristics

Implant material: PEEK Optima LT1 (ASTM F2026). Marker material: Tantalum (ASTM F560). Design features: fixation teeth, graft window, insertion hole. Mechanical testing standards: ASTM F2077, ASTM F2267. Non-sterile.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (C2-T1) requiring spinal fusion after 6 weeks of failed non-operative treatment. Must be used with supplemental internal fixation.

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

• LDR Spine Cervical Interbody Fusion System (K091088)
• LDR Spine ROI-C Cervical Cage (K113559)
• Aesculap CeSpace PEEK Spinal Implant System (K083311)
• Aleutian IBF System (K113138)
• Crystal™ Intervertebral Body Fusion Device (K073351)

Submission Summary (Full Text)

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K122588
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# JUN 1 2 2013

### 510(k) Summary

NAME OF SPONSOR:

Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020

510(k) CONTACT:

Tom Haueter Regulatory Affairs Manager Telephone: [phone] Facsimile: [phone] Email: [e-mail]

DATE PREPARED:

.

PROPRIETARY NAME:

COMMON NAME:

CLASSIFICATION:

DEVICE PRODUCT CODE:

PREDICATE DEVICES:

DEVICE DESCRIPTION:

Vusion® CS Plus 510(k)

July 11, 2012

Vusion® CS Plus

Intervertebral Body Fusion Device

21 CFR 888.3080, Intervertebral Body Fusion Device.

ODP

LDR Spine Cervical Interbody Fusion System (K091088) LDR Spine

ROI-C Cervical Cage (K113559) LDR Spine

Aesculap CeSpace PEEK Spinal Implant System (K083311) Aesculap® Implant Systems

Aleutian IBF System (K113138) K2M, Inc.

Crystal™ Intervertebral Body Fusion Device (K073351) Spinal Elements

The Vusion® CS Plus system is designed for cervical intervertebral body fusion. The implant is a non-sterile PEEK Optima LT1 (ASTM F2026) implant body and two tantalum (ASTM F560) marker pins and is provided in multiple footprints, lordotic angles, and heights to match patient's anatomy. The implant includes machined Section 5, 510(k) Summary Page 1 of 2

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fixation teeth on the superior and inferior surfaces, a graft window passing between the superior and inferior surfaces, and an insertion hole for implant placement . INTENDED USE: The Vusion® CS Plus device is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. . This device is intended to be used in patients who have had six weeks of non-operative treatment. TECHNOLOGICAL Vusion® CS Plus has the same technological characteristics as the CHARACTERISTICS: predicate devices. These include: t Intended use (as described above) . Basic design Material (PEEK) . . Sizes (widths, lengths, heights are within range(s) offered by the predicate systems) Therefore the fundamental scientific technology of Vusion® CS Plus is the same as previously cleared devices. The following non-clinical mechanical tests were conducted on the PERFORMANCE DATA: worst case configurations of Vusion® CS Plus: . Static and dynamic compression testing per ASTM F2077 . Static shear testing per ASTM F2077 Static and dynamic torsion testing per ASTM F2077 . . Subsidence testing per ASTM F2267

> The mechanical test results demonstrate that Vusion® CS Plus devices perform as well as or better than the predicate devices. Therefore, Vusion® CS Plus is as safe and effective as the predicates.

Based on similarities in intended use, design, materials, manufacturing methods, and packaging, Vusion® CS Plus is substantially equivalent to the previously cleared predicate devices. Mechanical test results demonstrate that the proposed Vusion® CS Plus is substantially equivalent to the predicate devices.

Vusion® CS Plus 510(k)

CONCLUSIONS:

Section 5, 510(k) Summary

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper portion of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Letter Dated: June 12, 2013

Ortho Development Corporation % Mr. Tom Haueter Regulatory Affairs Manager 12187 South Business Park Drive Draper, Utah 84020

Re: K122588

Trade/Device Name: Vusion® CS Plus Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: May 28, 2013 Received: May 29, 2013

Dear Mr. Haueter:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Mr. Tom Haueter

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/ReportaProblem/default.htm.for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Laurence D. Coyne -A

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

Enclosure

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## Indications for Use

510(k) Number (if known): K122588

Device Name: Ortho Development Vusion® CS Plus

Indications for Use:

The Vusion® CS Plus device is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.

This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine.

This device is intended to be used in patients who have had six weeks of non-operative treatment.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(Part 21 CFR 801 Subpart C) |
|-------------------------------------------------|---|--------|-----------------------------------------------------|
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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, RhD Division of Orthopedic Devices