The Alphatec Solus Anterior Lumbar Interbody Fusion (ALIF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades.

Device Description

The Alphatec Solus® Anterior Lumbar Interbody Fusion (ALIF) System is an intervertebral body fixation system consisting of implants with various heights and lordosis to accommodate individual patient pathology. System implants are manufactured from implant grade polyetheretherketone (PEEK), titanium anchoring blades and tantalum radiographic markers. System instruments are manufactured from stainless steel. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac® Spinal Fixation System, AspidaTM Anterior Lumbar Plating System, ILLICO® MIS Posterior Fixation System, ILLICO® FS Facet Fixation System, or the BridgePoint™ Spinous Process Fixation System.

AI/ML Overview

This document describes the premarket notification for the Alphatec SOLUS® Anterior Lumbar Interbody Fusion (ALIF) System, focusing on non-clinical testing to establish substantial equivalence.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria	Reported Device Performance
Static Axial Compression	Per ASTM F2077 Standards (Recognized Consensus)	"All testing passed established acceptance criteria."
Dynamic Axial Compression	Per ASTM F2077 Standards (Recognized Consensus)	"All testing passed established acceptance criteria."
Compression Shear Testing	Per ASTM F2077 Standards (Recognized Consensus)	"All testing passed established acceptance criteria."
Static Torsion	Per ASTM F2077 Standards (Recognized Consensus)	"All testing passed established acceptance criteria."
Dynamic Torsion	Per ASTM F2077 Standards (Recognized Consensus)	"All testing passed established acceptance criteria."
Subsidence Testing	Per ASTM F2267 Standards (Recognized Consensus)	"All testing passed established acceptance criteria."
Static Expulsion Testing	Per ASTM Draft Standard F-04.25.02.02 Standards	"All testing passed established acceptance criteria."

2. Sample Size Used for the Test Set and Data Provenance

This document does not specify the sample sizes (number of devices tested) for each of the non-clinical tests. It also does not discuss data provenance as these are non-clinical (mechanical) tests, not human studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this document. The device's performance was evaluated against engineering standards, not expert clinical ground truth from a test set of data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are relevant for clinical studies with expert reviewers, not for mechanical testing against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. This document pertains to the mechanical and material equivalence of a medical implant, not an AI or imaging device that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance was established by recognized consensus standards (ASTM F2077, ASTM F2267) and an ASTM Draft Standard (F-04.25.02.02) for mechanical and material properties. These standards define the acceptable range of performance for intervertebral body fusion devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no concept of a "training set" in the context of mechanical endurance and safety testing for a medical implant like the Alphatec SOLUS® system, which does not involve machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this type of device and testing.

Summary

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510(k) Summary

MAR 0 5 2013

Alphatec SOLUS® Anterior Lumbar Interbody Fusion System 510(k) Summary Date Prepared: December 21, 2012

I	Company:	Alphatec Spine, Inc.5818 El Camino RealCarlsbad, CA 92008.USA
II.	Contact:	Trevor J. DenboRegulatory Affairs SpecialistTelephone: 760-494-6951Fax: 760-431-0289
III.	Product Name:	SOLUS® Anterior Lumbar Interbody Fusion(ALIF) System
IV.	Common Name:	Intervertebral Fusion Device
V.	Regulation Number:	21 CFR 888.3080
VI.	Classification Product Code:	OVD
VII.	Device Equivalence:	SOLUS® Anterior Lumbar Interbody Fusion(ALIF) Spinal Spacer System - K102402 S.E.03/30/2011.

VIII. Description:

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IX. Indications for Use:

The Alphatec Solus® Anterior Lumbar Interbody Fusion (ALIF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades.

X. Summary of the Technological Characteristics:

The design, materials, and indications for use of the subject Alphatec Solus® Anterior Lumbar Interbody Fusion (ALIF) System are substantially equivalent to the previously cleared predicate Solus® Anterior Lumbar Interbody Fusion System (K102402). Both system implants are comprised of a PEEK cage surrounding two internal fixation anchor blades which are separated by a C-Ring.

XI. Discussion of the Non-clinical Testing:

Static Axial Compression, Dynamic Axial Compression, Compression Shear Testing, Static Torsion and Dynamic Torsion tests were conducted per ASTM F2077; Subsidence Testing was conducted per ASTM F2267 and Static Expulsion testing was conducted per ASTM Draft Standard F-04.25.02.02. ASTM F2077 and ASTM F2267 standards are Recognized Consensus Standards associated with the OVD product code per the FDA Product Classification.

XII. Non-clinical Testing Conclusions:

All testing passed established acceptance criteria. Based on the results of these tests the Alphatec Solus® Anterior Lumbar Interbody Fusion (ALIF) System is substantially equivalent to the predicate device.

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

March 5, 2013

Alphatec Spine, Incorporated % Mr. Trevor Denbo Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008

Re: K123993

Trade/Device Name: Alphatec Solus® Anterior Lumbar Interbody Fusion (ALF) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: December 21, 2012 Received: December 26, 2012

Dear Mr. Denbo:

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. Trevor Denbo

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Erin.DKeith

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): K123993

Device Name: Alphatec Solus® Anterior Lumbar Interbody Fusion (ALIF) System

Indications For Use:

× 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriëv, PhD Division of Orthopedic Devices

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Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
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.(b)
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.