(63 days)
Xenco Medical CancelleX Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of nonoperative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).
Xenco Medical CancelleX Cervical Interbody System devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. Spacers are manufactured from Titanium Alloy (TI-6AL-4V per ASTM F3001-14). The system also includes instruments manufactured using 6061 T6 Aluminum Alloy (per ASTM B211 / B221) and Stainless Steel (per ASTM F899). All system implants and instruments are provided sterile packaged and are intended for single use.
This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the Xenco Medical CancelleX Cervical Interbody System. It is not a study report for an AI/ML medical device.
Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML device is not present in this document.
The document focuses on demonstrating substantial equivalence of a physical medical device (an intervertebral body fusion device) to existing predicate devices. It discusses:
- Device Description: Generally box-shaped with surface teeth, a central channel for autogenous bone, available in various shapes and sizes, manufactured from Titanium Alloy.
- Indications for Use: Spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease, implanted via an open, anterior approach, packed with autogenous bone, used with supplemental fixation.
- Technological Comparison: Similar design and sizing to predicates, but 3D printed from titanium with porous latticed areas, similar to an additional predicate.
- Non-Clinical Test Summary & Conclusions: Benchtop mechanical testing was performed according to ASTM standards (F2077 for static/dynamic axial compression, compression shear, and torsion; F2267 for subsidence), and expulsion testing per lab protocol. The conclusion states that the subject device has at least equivalent mechanical strength as the predicates.
- Clinical Testing: The document explicitly states, "Clinical testing was not applicable for this submission."
Since this document pertains to a physical implantable device and not an AI/ML software device, none of the specific questions regarding AI/ML device performance, acceptance criteria, or study methodologies can be answered from the provided text.
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January 29, 2025
Xenco Medical, LLC % Jeffrey Brittan Vice President of Product Realization Watershed Idea Foundry, Inc. (dba SpiTrex 3D) 1815 Aston Ave., Ste 106 Carlsbad, California 92008
Re: K243673
Trade/Device Name: Xenco Medical CancelleX Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: November 19, 2024 Received: November 27, 2024
Dear Jeffrey Brittan:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director 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
Submission Number (if known)
Device Name
Xenco Medical CancelleX Cervical Interbody System
Indications for Use (Describe)
Xenco Medical CancelleX Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of nonoperative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Xenco Medical CancelleX SUMMARY:
Xenco Medical CancelleX Cervical Interbody System
| Date Prepared | November 7, 2024 |
|---|---|
| Applicant | Xenco Medical, LLCJason Haider, Founder and CEO9930 Mesa Rim RdSan Diego, CA 92121858-202-1522 ext. 202jhaider@xencomedical.com |
| Correspondent /Consultant | Jeffrey BrittanVice President of Product RealizationWatershed Idea Foundry, Inc. (dba SpiTrex 3D)jeffbrittan@spitrexorthopedics.com |
| Trade Name | Xenco Medical CancelleX Cervical Interbody System |
| Common Name | Intervertebral body fusion device |
| Code - Classification | Classification Name: Intervertebral Fusion Device With Bone Graft,CervicalRegulation Number: 21 CFR 888.3080Product Code: ODP |
| Primary PredicateDevice | K140786 Xenco Medical Cervical Interbody SystemProduct Code: ODP |
| Additional PredicateDevice | K222015 Integral Titanium Cervical InterbodyProduct Code: ODP |
| Device Description | Xenco Medical CancelleX Cervical Interbody System devices aregenerally box shaped with surface teeth and a central channel for packingautogenous bone. These implants are available in a range of shapes andsizes to accommodate variations in patient anatomy. Spacers aremanufactured from Titanium Alloy (TI-6AL-4V per ASTM F3001-14).The system also includes instruments manufactured using 6061 T6Aluminum Alloy (per ASTM B211 / B221) and Stainless Steel (per ASTMF899). All system implants and instruments are provided sterile packagedand are intended for single use. |
| Indications for UseStatement | Xenco Medical CancelleX Cervical Interbody System devices are intendedfor spinal fusion procedures at one level (C3-C7) in skeletally maturepatients with degenerative disc disease (defined as back pain of discogenicorigin with degeneration of the disc confirmed by history and radiographicstudies) of the cervical spine. Devices are to be implanted via an open,anterior approach and packed with autogenous bone. Patients should havehad at least six weeks of non-operative treatment prior to surgicaltreatment with the device. The device is intended to be used withsupplemental fixation (e.g. anterior plate system). |
| Indication for UseComparison | The subject device has the same intended use/indications for use as theprimary predicate. |
| TechnologicalComparison | The subject device has equivalent technological characteristics andperformance as the predicates. The subject device is designed in the samesizes and geometries with equivalent features as the primary predicate butis 3D printed from titanium, which allows inclusion of porous latticedareas. These porous features are equivalent to the additional predicate,which is also 3D printed using titanium and equivalently incorporateslattice.The subject device and the predicates all utilize equivalent design andsizing for equivalent functionality. These devices are all generally boxshaped with hollow channels to accommodate packing with bone graft, aswell as anterior holes for mating with an insertion instrument. The subjectdevices and predicates also equivalently incorporate linear rows of anti-migration features on the superior and inferior surfaces. |
| Non-Clinical TestSummary &Conclusions | Bench top mechanical testing was performed, which addressesrecommendations from the FDA Class II Special Controls GuidanceDocument - Intervertebral Body Fusion Device:Static and dynamic axial compression, compression shear, andtorsion per ASTM F2077 Subsidence per ASTM F2267 Expulsion testing per lab protocol Clinical testing was not applicable for this submission.The non-clinical testing demonstrates that the subject device has at leastequivalent mechanical strength as the predicates. Based on the similaritiesof the intended use/indications for use, technological and functionalcharacteristic, and the results of the non-clinical performancetesting, the subject device is substantially equivalent to and would performas well as the legally marketed predicate devices. |
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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.