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) premarket notification for a medical device called the "MOJAVE Expandable Interbody System". This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove the device meets these criteria in the way a clinical trial or a performance study for an AI/CADe device would.

Therefore, many of the requested categories are not applicable or cannot be extracted directly from this type of regulatory submission. This document aims to show the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance evaluations and comparative analysis of design, materials, and intended use.

Here's an analysis based on the provided text, indicating "N/A" (Not Applicable) or "Not Provided" where the information is not present in this 510(k) summary:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from predicate/standards)	Reported Device Performance (MOJAVE)
Static Compression, Torsion, Compression Shear (per ASTM F2077, implied)	Performed similarly to or better than predicate devices.
Dynamic Compression Shear (per ASTM F2077)	Performed similarly to or better than predicate devices.
Subsidence (per ASTM F2267)	Performed similarly to or better than predicate devices.
Expulsion (per ASTM F2267, implied)	Performed similarly to or better than predicate devices.
Bacterial Endotoxin Testing (BET) / Limulus Amebocyte Lysate (LAL) testing (per ANSI/AAMI/ST72:2011)	Testing was conducted in accordance with the standard. (Specific results not provided but implied to meet acceptance).

Note: The "acceptance criteria" here are implied by the performance of predicate devices and adherence to relevant ASTM and ANSI/AAMI standards for intervertebral body fusion devices. The exact numerical thresholds for "similarly to or better than" are not specified in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not provided. The non-clinical testing typically involves a specific number of devices per test, but this detail is not included in the summary.
Data Provenance: Not provided, but all testing would be conducted in a laboratory setting, likely in the US, as K2M, Inc. is based in Leesburg, Virginia. The data is non-clinical/pre-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This information is for clinical studies or studies establishing ground truth for diagnostic AI/CADe devices. This document describes mechanical and biological compatibility testing of an implantable device, not diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Not applicable for non-clinical performance evaluation of an implantable device.

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

N/A. This device is an intervertebral body fusion implant, not an AI/CADe diagnostic tool. Therefore, MRMC studies are not applicable.

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

N/A. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For non-clinical testing: The "ground truth" or reference for evaluating performance in a 510(k) for an implantable device like this typically comes from:
- Validated ASTM standards: These standards define how to perform tests (e.g., static compression, dynamic compression shear) and often include performance benchmarks or methodologies for comparison.
- Performance of legally marketed predicate devices: The new device must perform "similarly to or better than" established predicate devices under the same testing conditions.
The "ground truth" is not clinical pathology or outcomes data in this context, but rather engineering and material performance specifications.

8. The sample size for the training set

N/A. This refers to machine learning models. This document describes a physical medical device.

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

N/A. This refers to machine learning models. This document describes a physical medical device.

Summary

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle or other national symbol, with three overlapping profiles.

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

March 15, 2017

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

Re: K163364

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: February 9, 2017 Received: February 10, 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 devicerelated 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.

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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,

Lori A. Wiggins -S

for 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) K163364

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: 3/13/2017

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: Globus Caliber (K102293) Additional Predicates: K2M Aleutian (K082698, K133614) K2M Cascadia (K150481, K160125)

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

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nonoperative therapy. Additionally, the MOJA VE 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.

Technological Comparison to Predicate(s)

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

Non-clinical Performance Evaluation

The worst MOJAVE Expandable Interbody System implants were tested in static compression,

torsion, and compression shear; dynamic compression shear (per ASTM F2077); subsidence (per ASTM F2267) and expulsion and performed similarly to or better than predicate devices. 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.