(63 days)
Not Found
No
The summary describes a passive implant and surgical instruments, with no mention of AI/ML in the intended use, device description, or performance studies.
Yes.
The device is intended for spinal fusion procedures to treat degenerative disc disease, which addresses a medical condition and aims to restore function or alleviate symptoms.
No
Explanation: The device, Xenco Medical CancelleX Cervical Interbody System, is described as an implant used for spinal fusion procedures. Its function is to replace or support the intervertebral disc, not to identify or analyze medical conditions. It is a treatment device, not a diagnostic one.
No
The device description clearly states that the device is an implantable interbody system made of titanium alloy and includes instruments made of aluminum alloy and stainless steel. This indicates a hardware-based medical device, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant (a cervical interbody system) and associated instruments used during a surgical procedure to fuse vertebrae in the spine.
- Intended Use: The intended use is for spinal fusion procedures, which is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The device is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C3-C7)
Indicated Patient Age Range
skeletally mature patients
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)
Bench top mechanical testing was performed, which addresses recommendations from the FDA Class II Special Controls Guidance Document - Intervertebral Body Fusion Device: Static and dynamic axial compression, compression shear, and torsion 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 least equivalent mechanical strength as the predicates. Based on the similarities of the intended use/indications for use, technological and functional characteristic, and the results of the non-clinical performance testing, the subject device is substantially equivalent to and would perform as well as the legally marketed predicate devices.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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, LLC |
| Jason Haider, Founder and CEO | |
| 9930 Mesa Rim Rd | |
| San Diego, CA 92121 | |
| 858-202-1522 ext. 202 | |
| jhaider@xencomedical.com | |
| Correspondent / | |
| Consultant | Jeffrey Brittan |
| Vice President of Product Realization | |
| Watershed 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, |
| Cervical | |
| Regulation Number: 21 CFR 888.3080 | |
| Product Code: ODP | |
| Primary Predicate | |
| Device | K140786 Xenco Medical Cervical Interbody System |
| Product Code: ODP | |
| Additional Predicate | |
| Device | K222015 Integral Titanium Cervical Interbody |
| Product Code: ODP | |
| Device Description | 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. | |
| Indications for Use | |
| Statement | 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 back 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 non-operative treatment prior to surgical | |
| treatment with the device. The device is intended to be used with | |
| supplemental fixation (e.g. anterior plate system). | |
| Indication for Use | |
| Comparison | The subject device has the same intended use/indications for use as the |
| primary predicate. | |
| Technological | |
| Comparison | The subject device has equivalent technological characteristics and |
| performance as the predicates. The subject device is designed in the same | |
| sizes and geometries with equivalent features as the primary predicate but | |
| is 3D printed from titanium, which allows inclusion of porous latticed | |
| areas. These porous features are equivalent to the additional predicate, | |
| which is also 3D printed using titanium and equivalently incorporates | |
| lattice. |
The subject device and the predicates all utilize equivalent design and
sizing for equivalent functionality. These devices are all generally box
shaped with hollow channels to accommodate packing with bone graft, as
well as anterior holes for mating with an insertion instrument. The subject
devices and predicates also equivalently incorporate linear rows of anti-
migration features on the superior and inferior surfaces. |
| Non-Clinical Test
Summary &
Conclusions | Bench top mechanical testing was performed, which addresses
recommendations from the FDA Class II Special Controls Guidance
Document - Intervertebral Body Fusion Device:
Static and dynamic axial compression, compression shear, and
torsion 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 least
equivalent mechanical strength as the predicates. Based on the similarities
of the intended use/indications for use, technological and functional
characteristic, and the results of the non-clinical performance
testing, the subject device is substantially equivalent to and would perform
as well as the legally marketed predicate devices. |
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