The Valeo™ Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to L5 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

Device Description

The Valeo™ Pedicle Screw System comprises non-sterile, single use, titanium allov components for creating a posterior spinal implant construct. The system attaches to the spine through a component system comprising screws, rods, connectors, and set screws. The system is designed to stabilize the spine during the fusion process. The ValeoTM Pedicle Screw System is fabricated from wrought Ti-6A1-4V (ISO 5832-3).

AI/ML Overview

This document is a 510(k) summary for the Valeo™ Pedicle Screw System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding clinical studies, acceptance criteria for device performance (beyond substantial equivalence to predicate devices), or specific performance metrics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, nor can I provide information about:

A table of acceptance criteria and the reported device performance
Sample sizes used for the test set and data provenance
Number of experts used to establish ground truth and their qualifications
Adjudication method
MRMC comparative effectiveness study results or effect sizes
Standalone algorithm performance
Type of ground truth used
Sample size for the training set
How ground truth for the training set was established

The document primarily focuses on establishing substantial equivalence based on design, function, and materials to previously cleared devices. The "Performance Standards" section merely states "Testing performed indicates the Valeo™ Pedicle Screw System is substantially equivalent to predicate devices," but it does not detail what that testing entailed or what the specific performance criteria or results were.

Summary

{0}------------------------------------------------

5. 510(k) Summary

Contact:	Mr. Justin EggletonMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Device Trade Name:	Valeo™ Pedicle Screw System
Manufacturer:	Amedica Corp.615 Arapeen Drive, Suite 302Salt Lake City, UT 84108	NOV 1 9 2007
Common Name:	Pedicle screw spinal system
Classification:	21 CFR §888.3070
Class:	III
Product Code:	NKB, MNH, MNI

Indications For Use:

Device Description:

Predicate Device(s):

The Valeo™ Pedicle Screw System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. The cited references include:

{1}------------------------------------------------

Biomet Synergy VLS Open (K973836) .
Synthes Pangea (K052123) .
Zimmer Silhouette (K993067) .
Medtronic Sofamor Danek CD Horizon 3.5mm rods (K042962) .
Medtronic Sofamor Danek EQUATION™ Fixation System (K033495, K042453) .
U&I Corp Optima Spinal System (K024096, K031585) .
DePuy Spine MOSS Miami 4.0 Spinal System (K962628) .
Jemo Spine DELTATM Spinal Fusion System (K071857) .

Performance Standards:

Testing performed indicates the Valeo™ Pedicle Screw System is substantially equivalent to predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

NOV 1 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Amedica Corporation % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton 1331 H Street Northwest, 12th Floor Washington, DC 20005

Re: K072022

Trade/Device Name: Valeo" Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH Dated: November 1, 2007 Received: November 2, 2007

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

{3}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

4. Indications for Use

510(k) Number (if known):

Device Name: Valeo™ Pedicle Screw System

The Valeo™ Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to L5 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

マ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sabare benn Pofor nyxm

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K07022

Regulation Number and Section

N/A