Valeo C Spacer System, Valeo II C IBF Device

K142264 · Amedica Corp. · ODP · Dec 8, 2014 · Orthopedic

Device Facts

• Record ID: K142264
• Device Name: Valeo C Spacer System, Valeo II C IBF Device
• Applicant: Amedica Corp.
• Product Code: ODP · Orthopedic
• Decision Date: Dec 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K142264 · Dec 8, 2014	Valeo C Spacer System, Valeo II C IBF Device	Amedica Corp.	Clinical literature review of patient outcomes	A clinical literature review was conducted to assess the safety of using the device with allograft and at two contiguous cervical levels, supporting the expansion of indications for use.	Literature review; Safety assessment; Expanded indications

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Clinical literature review; Literature review	Patients undergoing cervical fusion at two levels using allograft	Not applicable for this study	Safety and performance of allograft use at two cervical levels

Indications for Use

Valeo™ Spacer System-C and ValerM II Interbody Fusion Device System -Cervical are indicated for use in sketally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Valeo™ System-C and Valeo™ II Interbody Fusion Device System -Cervical are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. Valeo™ Spacer System-L and Valeo™ II Interbody Fusion Device System - Lumbar are indicated for use with autograft bone graft in patients with DDD at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo™ Spacer System-L and Valeo™ II Interbody Fusion Device System - Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.

Device Story

Hollow intervertebral body spacers; convex, bullet-nose design; axial void for bone graft; angular teeth for endplate grip/expulsion resistance. Used in cervical (C2-T1) or lumbar (L2-S1) spine fusion. Implanted by surgeons via anterior approach. Facilitates fusion using autograft or allogenic bone graft. Supplemental fixation required. Benefits patient by stabilizing disc space and promoting fusion in DDD cases.

Clinical Evidence

No clinical trials performed. Substantial equivalence supported by clinical literature review assessing safety of two-level cervical application and allograft use.

Technological Characteristics

Materials: MC2 ceramic (silicon nitride). Design: Hollow intervertebral spacer with axial void, convex bullet-nose, and angular teeth. Sterile. Standalone implant.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) with radicular symptoms at 1-2 levels, or lumbar spine (L2-S1) with DDD/Grade I spondylolisthesis at 1-2 levels. Requires supplemental fixation and prior non-operative therapy (6 weeks cervical, 6 months lumbar).

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

• ANATOMIC PEEK™ Cervical FUSION SYSTEM (K130177)

Reference Devices

• Preference Pedicle Screw System

Submission Summary (Full Text)

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

December 8, 2014

Amedica® Corporation % Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors, LLC 1331 H Street, Northwest 12th Floor Washington DC, 20005

Re: K142264

Trade/Device Name: Valeo™ Spacer System, Valeo™ II Interbody Fusion Device System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: September 8, 2014 Received: September 9, 2014

Dear Mr. Eggleton:

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. Justin Eggleton

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 Industry and Consumer Education at its toll-free 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/Safety/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

## Mark N. Melkerson -S

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) K142264

#### Device Name

Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System

#### Indications for Use (Describe)

Valeo™ Spacer System-C and ValerM II Interbody Fusion Device System -Cervical are indicated for use in sketally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Valeo™ System-C and Valeo™ II Interbody Fusion Device System -Cervical are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Valeo™ Spacer System-L and Valeo™ II Interbody Fusion Device System - Lumbar are indicated for use with autograft bone graft in patients with DDD at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo™ Spacer System-L and Valeo™ II Interbody Fusion Device System - Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.

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

ال Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

| Device Trade Name: | Valeo™ Spacer System (Valeo™ Spacer System –C and Valeo™<br>Spacer System –L)<br>Valeo™ II Interbody Fusion Device System (Valeo™ II Interbody<br>Fusion Device System -Cervical and Valeo™ II Interbody Fusion<br>Device System – Lumbar) |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | AMEDICA® Corporation<br>1885 West 2100 South<br>Salt Lake City, UT 84119<br>Phone: [phone] |
| Contact: | Mr. William D. Jordan<br>Senior Director Regulatory Affairs and Quality Assurance |
| Prepared by: | Mr. Justin Eggleton<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | December 5, 2014 |
| Classifications: | 21 CFR §888.3080, Intervertebral Body Fusion Device |
| Class: | II |
| Product Codes: | MAX, ODP |

## Indications For Use:

Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

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Valeo™ System-L and Valeo™ II Interbody Fusion Device System - Lumbar are indicated for use with autograft bone graft in patients with DDD at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo™ Spacer System-L and Valeo™ II Interbody Fusion Device System - Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.

## Device Description:

The Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System devices consist of a variety of hollow intervertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material per the indications stated above. The subject device is offered in various geometries to accommodate different surgical approaches and vertebral body dimensions. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical is manufactured from MC2 ceramic material (silicon nitride), and is provided sterile.

The purpose of the subject 510(k) was to expand the indications of the Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical devices to include use with allograft and use at two contiguous levels from C2/C3 to C7/T1.

## Predicate Device:

The modifications to the Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System are substantially equivalent to the predicate ANATOMIC PEEK™ Cervical FUSION SYSTEM (K130177) with respect to indications, design, and performance.

### Substantial Equivalence:

The Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System and predicate ANATOMIC PEEK™ Cervical FUSION SYSTEM are similar in design and indicated use, and are both cleared devices. They do differ in that the ANATOMIC PEEK "" is indicated for use with allogenic bone graft. A comprehensive clinical literature review was conducted to assess any additional safety concern for the use of this device at two cervical levels with the use of allograft. The review of the literature concluded that there were no additional risks due to the modification of indications for this device and that the device was substantially equivalent to the predicate device.

## Conclusion:

This 510(k) was submitted on behalf of the Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System (cervical interbody cages only) to expand the indications for use to include use with allograft and use at two contiguous levels from C2/C3 to C7/T1. Substantial equivalence was determined in response to sufficient comparisons to a predicate device.