Who is the manufacturer of Valeo Spacer System and Valeo II Interbody Fusion Device System?

Amedica Corp. filed the 510(k) submission for Valeo Spacer System and Valeo II Interbody Fusion Device System (K143518).

What is the FDA product code for Valeo Spacer System and Valeo II Interbody Fusion Device System?

MAX. It is classified under 21 CFR 888.3080 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Valeo Spacer System and Valeo II Interbody Fusion Device System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Valeo Spacer System and Valeo II Interbody Fusion Device System?

Valeo II™ Interbody Fusion Device (K142264); Valeo® Spacer System (K091278).

Who can help prepare an FDA 510(k) submission like Valeo Spacer System and Valeo II Interbody Fusion Device System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Valeo Spacer System and Valeo II Interbody Fusion Device System

K143518 · Amedica Corp. · MAX · Oct 2, 2015 · Orthopedic

Device Facts

Record ID	K143518
Device Name	Valeo Spacer System and Valeo II Interbody Fusion Device System
Applicant	Amedica Corp.
Product Code	MAX · Orthopedic
Decision Date	Oct 2, 2015
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
K143518 · Oct 2, 2015	Valeo Spacer System and Valeo II Interbody Fusion Device System	Amedica Corp.	Clinical literature review	A clinical literature review was conducted to assess the safety and risks associated with using the Valeo Spacer System and Valeo II Interbody Fusion Device System with allograft in lumbar fusion procedures, supporting the expansion of indications.	Literature review; Lumbar fusion; Allograft; Safety assessment

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Clinical literature review; Literature review	Patients undergoing lumbar fusion procedures	Not applicable for this study	Safety and risks associated with the use of the device with allograft in the lumbar spine

Indications for Use

Valeo® Spacer System 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. Valeo® Spacer System-L and Valeo II™ Interbody Fusion Device System - Lumbar are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft in patients with degenerative disc disease (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 (autograft/allograft); angular teeth for endplate grip/expulsion resistance. Used in spinal fusion surgery; placed via anterior approach (cervical) or lumbar approach. Operated by surgeons in clinical/OR settings. Provides structural support to facilitate intervertebral fusion; used with supplemental fixation systems. Benefits patients by stabilizing spinal segments and promoting fusion in DDD cases.

Clinical Evidence

No clinical trials performed. Evidence based on a comprehensive clinical literature review assessing safety of using the device with allograft in lumbar fusion procedures. Review concluded no additional risks compared to predicate devices.

Technological Characteristics

Material: Si3N4 (silicon nitride) ceramic. Design: Hollow spacer with axial void, convex bullet-nose, and angular teeth for fixation. Provided sterile. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) or lumbar spine (L2-S1) at one or two contiguous levels. Cervical patients must have radicular symptoms; lumbar patients may have up to Grade I spondylolisthesis. Requires 6 weeks (cervical) or 6 months (lumbar) of non-operative therapy. Must be used with supplemental fixation and autograft or allogenic bone graft.

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

Valeo II™ Interbody Fusion Device (K142264)
Valeo® Spacer System (K091278)

Reference Devices

Preference Pedicle Screw System

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 2, 2015 AMEDICA® Corporation Mr. William D. Jordan Senior Director Regulatory Affairs and Quality Assurance 1885 West 2100 South Salt Lake City, Utah 84119 Re: K143518 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: MAX, ODP Dated: September 2, 2015 Received: September 4, 2015 Dear Mr. Jordan: 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 {1}------------------------------------------------ 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, ## Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K143518 #### Device Name Valeo® Spacer System; Valeo II™ Interbody Fusion Device System #### Indications for Use (Describe) Valeo® Spacer System 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. Valeo® Spacer System-L and Valeo II™ Interbody Fusion Device System - Lumbar are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft in patients with degenerative disc disease (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) | | 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| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)…

Valeo Spacer System and Valeo II Interbody Fusion Device System

Device Facts

Real-World Evidence

Clinical Evidence

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Valeo Spacer System and Valeo II Interbody Fusion Device System

Device Facts

Real-World Evidence

Clinical Evidence

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

Special Control Matches

My Alerts

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