(90 days)
Not Found
No
The summary describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an intervertebral body fusion device indicated for use in patients with degenerative disc disease, which implies a therapeutic intent to treat a medical condition.
No
The device description clearly states that the MOJAVE Expandable Interbody System is comprised of "expandable titanium implants" designed to aid surgeons in matching implant fit. Its intended use is for intervertebral body fusion, and it is described as an "adjunct to fusion." These are all characteristics of a therapeutic or surgical device, not a diagnostic one. Diagnostic devices are used to identify or characterize a disease or condition, which this device does not do.
No
The device description clearly states it is comprised of physical implants made from titanium and cobalt chromium alloys, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The MOJAVE Expandable Interbody System is an implantable surgical device designed to be placed within the body (specifically, the lumbar spine) to aid in spinal fusion. It is made of titanium and cobalt chromium alloys.
- Intended Use: The intended use is to provide structural support and promote bone fusion in patients with degenerative disc disease and degenerative scoliosis. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The provided information clearly describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / 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 bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DOD) 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MAX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine, lumbosacral spine)
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A risk assessment, including benchtop and mechanical testing, was conducted to confirm that the subject MOJAVE Expandable Interbody System does not introduce new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 18, 2020
K2M, Inc. % Ms. Megan Callanan Regulatory Affairs Associate Stryker 2 Pearl Court Allendale, New Jersey 07401
Re: K193203
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: January 17, 2020 Received: January 21, 2020
Dear Ms. Callanan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Brent L. Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193203
Device Name MOJAVE Expandable Interbody System
Indications for Use (Describe)
The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DOD) 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 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| 510(k) Summary: MOJAVE Expandable Interbody System | |
|---|---|
| Submitter: | K2M, Inc. |
| Hope Parkway SE | |
| Leesburg, VA 20175 | |
| Contact Person : | Name: Megan Callanan |
| Phone: (551)262-2429 | |
| Email: megan.callanan1@stryker.com | |
| Date Prepared: | 11/19/2019 |
| Trade Name: | MOJAVE Expandable Interbody System |
| Common Name: | Intervertebral Fusion Device with Bone Graft |
| Proposed Class: | Class II |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, lumbar |
| Regulation Number: | 21 CFR 888.3080 |
| Product Code: | MAX |
| Predicate Devices: | Primary Predicate: MOJAVE Expandable Interbody System (K171097) |
| Additional Predicate: MOJAVE Expandable Interbody System (K163364) | |
| 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. | |
| 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 (DOD) 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. | |
| 510(k) Summary: MOJAVE Expandable Interbody System | |
| Technological Comparison | |
| to Predicate | The proposed MOJAVE Expandable Interbody System incorporates minor |
| modifications to the system to enhance user experience. The enhancements | |
| were compared to the predicate system and were found to be comparable in | |
| design, function, intended use, materials, and size. | |
| Non-clinical Performance | |
| Evaluation | A risk assessment, including benchtop and mechanical testing, was conducted |
| to confirm that the subject MOJAVE Expandable Interbody System does not | |
| introduce new issues of safety or effectiveness. | |
| Conclusion | There are no significant differences between the MOJAVE Expandable |
| Interbody System and other devices currently being marketed which would | |
| adversely affect the use of the product. Therefore, the MOJAVE Expandable | |
| Interbody System is substantially equivalent to the predicate system. |
4