(90 days)
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.
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.
The provided document describes an FDA 510(k) clearance for the MOJAVE Expandable Interbody System. This is a medical device, not an AI/software product, and the information provided does not include acceptance criteria or a study proving that an AI/software device meets acceptance criteria.
The document discusses the substantial equivalence of the MOJAVE Expandable Interbody System to predicate devices based on:
- Technological Comparison to Predicate: Minor modifications to enhance user experience, comparable in design, function, intended use, materials, and size.
- Non-clinical Performance Evaluation: Risk assessment, including benchtop and mechanical testing, to confirm no new issues of safety or effectiveness.
Therefore, I cannot provide the requested information for an AI/software device from this text as it is not applicable.
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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.
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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
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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)
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| 510(k) Summary: MOJAVE Expandable Interbody System | |
|---|---|
| Submitter: | K2M, Inc.Hope Parkway SELeesburg, VA 20175 |
| Contact Person : | Name: Megan CallananPhone: (551)262-2429Email: 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 expandabletitanium implants designed to allow for intraoperative adjustment to aid thesurgeon in matching implant fit to the vertebral anatomy in the lumbar spine.The implants have titanium endplates designed to allow for bone ingrowthand engagement with the vertebral body end plates. The implants aremanufactured from medical grade titanium alloy (ASTM F1472, ASTM F136,ASTM F3001) and cobalt chromium alloy (ASTM F1537) and are available in avariety of heights to accommodate anatomical variations. |
| Indications for Use: | The MOJAVE Expandable Interbody System implants are intervertebral bodyfusion devices indicated for use with autograft and/or allogenic bone graftcomprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease (DOD) at onelevel or two contiguous levels from L2 to S1. DDD is defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history andradiographic studies. The DDD patients may also have up to Grade Ispondylolisthesis or retrolisthesis at the involved level(s). These patientsshould be skeletally mature and have six months of nonoperative therapy.Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusionin patients diagnosed with degenerative scoliosis. MOJAVE lumbar implantsare intended to be used with supplemental spinal fixation systems that havebeen cleared for use in the lumbosacral spine. |
| 510(k) Summary: MOJAVE Expandable Interbody System | |
| Technological Comparisonto Predicate | The proposed MOJAVE Expandable Interbody System incorporates minormodifications to the system to enhance user experience. The enhancementswere compared to the predicate system and were found to be comparable indesign, function, intended use, materials, and size. |
| Non-clinical PerformanceEvaluation | A risk assessment, including benchtop and mechanical testing, was conductedto confirm that the subject MOJAVE Expandable Interbody System does notintroduce new issues of safety or effectiveness. |
| Conclusion | There are no significant differences between the MOJAVE ExpandableInterbody System and other devices currently being marketed which wouldadversely affect the use of the product. Therefore, the MOJAVE ExpandableInterbody System is substantially equivalent to the predicate system. |
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§ 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.