(16 days)
No
The device description and intended use focus on mechanical components for spinal fixation and do not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is described as a "Lumbar Facet Fixation System" intended for "temporary stabilization of the spine as an adjunct to fusion" and for the "treatment of patients with lumbar degenerative disease." These descriptions clearly indicate its use in treating a medical condition and affecting the structure or function of the body, which aligns with the definition of a therapeutic device.
No.
Explanation: The device is described as a "Lumbar Facet Fixation System" intended for "temporary stabilization of the spine as an adjunct to fusion," indicating its purpose is therapeutic (fixation and stabilization) rather than diagnostic.
No
The device description explicitly details physical components (modular spacer, facet screws, instruments) made of titanium, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The zLOCK Lumbar Facet Fixation System is a surgical implant designed to be placed within the body to stabilize the spine. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use is for temporary stabilization of the spine as an adjunct to fusion, treating lumbar degenerative disease. This is a surgical intervention, not a diagnostic test.
The information provided clearly describes a surgical implant and its use in a surgical procedure, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The zLOCK Lumbar Facet Fixation System is an integrated construct comprised of a modular spacer and a single facet screw. The system is intended for temporary stabilization of the spine as an adjunct to fusion through bilateral immobilization of the facet joints in skeletally mature patients.
The zLOCK Lumbar Facet Fixation System is intended for use as an adjunct to a 1-level interbody lumbar fusion from L3 to L5 with autogenous and/or allogenic bone graft and must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The zLOCK Lumbar Facet Fixation System is indicated for the treatment of patients with lumbar degenerative disease at a single level from L3 to L5 in skeletally mature patients who have failed conservative care.
Product codes
MRW
Device Description
The zLOCK Lumbar Facet Fixation System is composed of a modular spacer and facet screws as an integrated construct to achieve posterior lumbar facet fixation as an adjunct to fusion. All implants are supplied sterile for single use only. The modular spacers are available in one footprint with a variety of heights to accommodate varying anatomical conditions of the patient, contain a screw hole, and are bendable with toothed surfaces to firmly anchor into the joint space and contain bone graft. The facet screw is cannulated, self-tapping, with a preassembled polyaxial washer; it is provided in one size. The modular spacer and facet screw are manufactured from Titanium Grade 1 and Titanium 6Al 4V alloy, respectively.
The system is supplied with a set of non-sterile, reusable instruments to access the site, prepare it for implantation, and perform device implantation.
The purpose of this 510(k) was to add a new screw size to the previously cleared zLOCK Lumbar Facet Fixation System (K240085) and to modify the length of the spacer component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (L3 to L5)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
Non-clinical testing performed on the subject zLOCK Lumbar Facet Fixation System supports substantial equivalence to predicate devices.
- Axial Pullout per ASTM F543
- Driving Torque per ASTM F543
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
September 20, 2024
Image /page/0/Picture/1 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ZygoFix, Ltd. % Mr. Justin Eggleton Vice President, Head of Musculoskeletal Regulatory Affairs MCRA, LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K242650
Trade/Device Name: zLOCK Lumbar Facet Fixation System Regulatory Class: Unclassified Product Code: MRW Dated: September 3, 2024 Received: September 4, 2024
Dear Mr. Eggleton:
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" (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).
1
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 QS 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-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 medical devices and radiation-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, Digitally signed Eileen by Eileen Cadel Cadel --S
Date: 2024.09.20 S 12:14:52 -04'00' for
Colin O'Neill, M.B.E. 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
3
Indications for Use
510(k) Number (if known) K242650
Device Name zLOCK Lumbar Facet Fixation System
Indications for Use (Describe)
The zLOCK Lumbar Facet Fixation System is an integrated construct comprised of a modular spacer and a single facet screw. The system is intended for temporary stabilization of the spine as an adjunct to fusion through bilateral immobilization of the facet joints in skeletally mature patients.
The zLOCK Lumbar Facet Fixation System is intended for use as an adjunct to a 1-level interbody lumbar fusion from L3 to L5 with autogenous and/or allogenic bone graft and must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The zLOCK Lumbar Facet Fixation System is indicated for the treatment of patients with lumbar degenerative disease at a single level from L3 to L5 in skeletally mature patients who have failed conservative care.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
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
| Submitter: | Zygofix, Ltd.
17 T'helet St.
Misgay Business Park
Misgay M.P.
2017400, Israel |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Justin Eggleton
Vice President, Head of Musculoskeletal Regulatory Affairs
MCRA, LLC
803 7th Street NW
Washington, DC 20001
Phone: (202)-552-5804
jeggleton@mcra.com |
| Date Prepared: | September 5, 2024 |
| Trade Name: | zLOCK Lumbar Facet Fixation System |
| Common Name: | Facet Joint Fixation System |
| Classification: | Unclassified |
| Product Code: | MRW; System, Facet Screw Spinal Device |
Primary Predicate Device: zLOCK Lumbar Facet Fixation System (K240085)
Device Description:
The zLOCK Lumbar Facet Fixation System is composed of a modular spacer and facet screws as an integrated construct to achieve posterior lumbar facet fixation as an adjunct to fusion. All implants are supplied sterile for single use only. The modular spacers are available in one footprint with a variety of heights to accommodate varying anatomical conditions of the patient, contain a screw hole, and are bendable with toothed surfaces to firmly anchor into the joint space and contain bone graft. The facet screw is cannulated, self-tapping, with a preassembled polyaxial washer; it is provided in one size. The modular spacer and facet screw are manufactured from Titanium Grade 1 and Titanium 6Al 4V alloy, respectively.
The system is supplied with a set of non-sterile, reusable instruments to access the site, prepare it for implantation, and perform device implantation.
The purpose of this 510(k) was to add a new screw size to the previously cleared zLOCK Lumbar Facet Fixation System (K240085) and to modify the length of the spacer component.
5
Indications for Use:
The zLOCK Lumbar Facet Fixation System is an integrated construct comprised of a modular spacer and a single facet screw. The system is intended for temporary stabilization of the spine as an adjunct to fusion through bilateral immobilization of the facet joints in skeletally mature patients.
The zLOCK Lumbar Facet Fixation System is intended for use as an adjunct to a 1-level interbody lumbar fusion from L3 to L5 with autogenous and/or allogenic bone graft and must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The zLOCK Lumbar Facet Fixation System is indicated for the treatment of patients with lumbar degenerative disc disease at a single level from L3 to L5 in skeletally mature patients who have failed conservative care.
Performance Testing:
Non-clinical testing performed on the subject zLOCK Lumbar Facet Fixation System supports substantial equivalence to predicate devices. The following testing were presented:
- Axial Pullout per ASTM F543 ●
- Driving Torque per ASTM F543
Substantial Equivalence:
The subject zLOCK Lumbar Facet Fixation System is substantially equivalent to the previously cleared version in K240085 with respect to intended use, materials, design, and function.
Conclusion:
The subject device and the primary predicate device have the same intended use, have similar technological characteristics, and are made of the same materials. The subject and primary predicate device are packaged in the same materials and are sterilized using the same methods. The data included in this submission demonstrate substantial equivalence to the primary predicate device listed above.