The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion 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 radios. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Device Description

The MOJAVE Expandable Interbody System is comprised of expandable titanium implants designed to allow for intraoperative adjustment to aid the surgeon in matching implant fit to the vertebral anatomy in the lumbar spine. The implants have titanium endplates designed to allow for bone ingrowth and engagement with the vertebral body end plates. The implants are manufactured from medical grade titanium alloy (ASTM F1472, ASTM F136, ASTM F3001) and cobalt chromium alloy (ASTM F1537) and are available in a variety of heights to accommodate anatomical variations.

AI/ML Overview

This is a 510(k) summary for a medical device called the "MOJAVE Expandable Interbody System," which is an implant used in spinal fusion surgery. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of a study against specific acceptance criteria for performance metrics.

Therefore, many of the requested details, such as acceptance criteria table with device performance, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information, are not present in this summary. These types of studies are typically not required for 510(k) submissions focusing on substantial equivalence for orthopedic implants.

Here's what can be inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not explicitly provided as a table with specific performance metrics and acceptance criteria. The "Non-clinical Performance Evaluation" section vaguely describes the types of tests performed.

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Meet or exceed predicate device performance in static compression, static torsion, etc.	"Confirmatory (static and dynamic) mechanical testing and simulated use (cadaver) testing was performed on the subject device verifying that the subject devices were not a new worst case."
Meet bacterial endotoxin limits	"bacterial endotoxin testing (BET)... was conducted in accordance with ANSI/AAMI/ST72:2011."

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified. The document mentions "worst case MOJAVE Expandable Interbody System implants" for mechanical testing and "simulated use (cadaver) testing." The number of cadavers or implants tested is not provided.
Data Provenance: The mechanical and simulated use testing would be laboratory/pre-clinical data, not human patient data. No country of origin is mentioned for this testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The tests performed are mechanical and simulated use, not those requiring expert interpretation of patient data for ground truth.

4. Adjudication method for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an implant, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is an implant, not an algorithm.

7. The type of ground truth used:

For mechanical testing: Engineering specifications and measurements of force, torque, displacement, and cycles.
For bacterial endotoxin testing: Laboratory measurement of LAL activity against established endotoxin limits.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002.

May 10, 2017

K2M, Inc. Nancy Giezen Manager Regulatory Affairs 600 Hope Parkway SE Leesburg, Virginia 20175

Re: K171097

Trade/Device Name: MOJAVE Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: April 11, 2017 Received: April 13, 2017

Dear Ms. Giezen:

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

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related adverse events) (21 CFR 803); 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.

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

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) K171097

Device Name MOJAVE Expandable Interbody System

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary MOJAVE Expandable Interbody System K2M, Inc.

Submitter

K2M, Inc. 600 Hope Pkwy SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: (571) 919-2000 Date Prepared: 5/8/2017

Classification

Trade Name:	MOJAVE Expandable Interbody System
Common Name:	Intervertebral Fusion Device with Bone Graft
Regulatory Class:	Class II

Classification Name(s): Intervertebral Fusion Device with Bone Graft, lumbar (21 CFR 888.3080, Product Code: MAX)

Predicate Device(s)

Primary Predicate: K2M MOJAVE Expandable Interbody System (K163364)

Device Description

Indications for Use

The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion 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 or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

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Technological Comparison to Predicate(s)

The MOJAVE Expandable Interbody System was compared to predicate systems and was found to be comparable to these systems in design, function, intended use, materials, and size.

Non-clinical Performance Evaluation

The worst case MOJAVE Expandable Interbody System implants were previously tested in static compression, static torsion, static compression shear and dynamic compression (per ASTM F2077), subsidence (per ASTM F2267) and expulsion. Confirmatory (static and dynamic) mechanical testing and simulated use (cadaver) testing was performed on the subject device verifying that the subject devices were not a new worst case. In addition, bacterial endotoxin testing (BET), also known as limulus amebocyte lysate (LAL) testing, was conducted in accordance with ANSI/AAMI/ST72:2011.

Conclusion

There are no significant differences between the MOJAVE spacers and other devices currently being marketed which would adversely affect the use of the product. Therefore the MOJAVE Expandable Interbody System implants are substantially equivalent to predicate devices.

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.