When used as a cervical intervertebral body fusion device, the Maxim Surgical X-Treme Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The Maxim Surgical X-Treme Interbody Fusion System is a cervical interbody fusion system comprised of neutral and lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.

The Maxim Surgical X-Treme Interbody Fusion System implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

The Maxim Surgical X-Treme Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

AI/ML Overview

The Maxim Surgical X-Treme Interbody Fusion System is a cervical interbody fusion device. The acceptance criteria and the study that proves the device meets the acceptance criteria are outlined below:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Test Standard)	Reported Device Performance (Compliance)
Static and dynamic compression testing (ASTM F2077-11)	Conforms to standard
Static and dynamic torsion testing (ASTM F2077-11)	Conforms to standard
Subsidence testing (ASTM F2267-04)	Conforms to standard
Expulsion testing (ASTM Draft Standard F-04.25.02.02)	Conforms to standard

2. Sample Size and Data Provenance for Test Set:

Sample Size: Not explicitly stated for each test. The document indicates that "non-clinical testing" was conducted on the device.
Data Provenance: The data is generated from non-clinical laboratory testing of the device itself. This is prospective data generation for testing the device's mechanical properties. The country of origin for the data is not specified but is implicitly associated with the manufacturer (Maxim Surgical, Richardson, Texas, USA).

3. Number of Experts and Qualifications for Ground Truth of Test Set:

Not applicable. The ground truth for this device's performance is based on quantifiable engineering standards and mechanical test results, not expert interpretation of clinical data or images.

4. Adjudication Method for Test Set:

Not applicable. As the performance is based on standardized mechanical tests, there is no need for expert adjudication. The results are objective measurements against predefined criteria in the ASTM standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a medical device (interbody fusion system), not an AI diagnostic or interpretive system. The study focuses on the physical and mechanical properties of the implant.

6. Standalone Performance Study:

Yes, a standalone study of the device's mechanical performance was conducted. This refers to the non-clinical testing performed on the Maxim Surgical X-Treme Interbody Fusion System itself, independent of human interaction during testing, to ensure it meets established safety and performance standards. The "Discussion of Non-Clinical Testing" section explicitly lists these tests.

7. Type of Ground Truth Used:

The ground truth used for the acceptance criteria and performance evaluation is based on established engineering and material science standards (ASTM standards) for intervertebral body fusion devices. These standards define the acceptable mechanical properties and performance characteristics (e.g., strength, resistance to subsidence, resistance to expulsion) of such implants.

8. Sample Size for Training Set:

Not applicable. This device is a physical implant, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI or data-driven models.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set for this device.

Summary

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K123206 Page 1 of 2

FEB 0 7 2013

510(k) Summary Maxim Surgical X-Treme Interbody Fusion System Premarket Notification

SUBMITTED BY

ﺮ

Maxim Surgical 1565 North Central Expressway, Suite 200 Richardson, Texas 75080

ESTABLISHMENT REGISTRATION NUMBER

Pending

OWNER/OPERATOR NUMBER

Pending

CONTACT PERSON

Chris Reeg President Maxim Surgical Phone: 214-564-1350 Fax: 972-692-8934

SUBMISSION PREPARED BY

Lisa Peterson Kaedon Consulting, LLC Phone: 512-507-0746

Intervertebral Body Fusion Device

888.3080 (Product Code ODP)

DATE PREPARED

January 9, 2013

CLASSIFICATION NAME

DEVICE CLASS

Class II

REGULATION NUMBER

COMMON NAME

PROPRIETARY NAME

IDENTIFICATION OF PREDICATE DEVICE(S)

Intervertebral Fusion Device with Bone Graft, Cervical

Maxim Surgical X-Treme Interbody Fusion System

Predicate devices include various cleared interbody fusion systems:

-Zimmer Spine: BAK/C (P980048)
ﻬ LDR Spine: MC+ (K043479, K091088)
-Eminent Spine: Eminent Spine Interbody Fusion System (K090064)
-SpineNet, LLC: Daytona Anterior Cervical Cage (K110733)

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DEVICE DESCRIPTION

INDICATIONS

When used as a cervical intervertebral body fusion device, the Maxim Surgical X-Treme Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with decenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-Tl disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograff to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The purpose of this premarket notification is to obtain clearance to market the Maxim Surgical X-Treme Interbody Fusion System. The Maxim Surgical X-Treme Interbody Fusion System is comprised of neutral and lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.

The subject system has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion:

Intended for use at one level from the C2-C3 disc to the C7-TI disc for the treatment of degenerative disc disease (DDD) of the cervical spine with accompanying radicular symotoms.
Substantially equivalent results of non-clinical testing relative to static and dynamic testing -(per ASTM F2077-11 ), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02)

DISCUSSION OF NON-CLINICAL TESTING

The following non-clinical tests were conducted:

Static and dynamic compression testing, conducted in accordance with ASTM F2077-11 י
Static and dynamic torsion testing, conducted in accordance with ASTM F2077-11 ।
Subsidence testing, conducted in accordance with ASTM F2267-04 י
Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02 1

CONCLUSIONS

The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Maxim Surgical X-Treme Interbody Fusion System is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 emblem with three curved lines, resembling a human figure, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the emblem. The emblem is positioned to the right of the text.

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

Letter dated: February 7, 2013

Maxim Surgical % Mr. Chris Reeg President 1565 North Central Expressway, Suite 200 Richardson, TX 75080

Re: K123206

Trade/Device Name: Maxim Surgical X-Treme Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 16, 2013 Received: January 16, 2013

Dear Mr. Reeg:

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. Chris Reeg

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/CDRH/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

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

K123206 510(k) Number (if known):

Maxim Surgical X-Treme Interbody Fusion System Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stephanie Beghtold -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123206

1565 North Central Expressway, Suite 200 Richardson, Texas 75080

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.