(98 days)
No
The 510(k) summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical testing and clinical outcomes related to the implant's physical properties and efficacy in fusion.
Yes.
The device is intended for the temporary stabilization of the spine as an adjunct to fusion for skeletally mature patients who have failed conservative care, directly treating a medical condition with a therapeutic aim.
No
Explanation: The zLOCK Lumbar Facet Fixation System is described as an "integrated construct comprised of a modular spacer and a single facet screw" intended for "temporary stabilization of the spine as an adjunct to fusion." It is a physical implant designed to treat a condition, not to identify or diagnose one. The "Intended Use / Indications for Use" section specifies its use for "treatment of patients with lumbar degenerative disc disease," and the "Device Description" explains its components as an implant, reinforcing its role as a therapeutic device.
No
The device description clearly states it is comprised of physical components (modular spacer and facet screw) made of Titanium, and is supplied with reusable instruments for implantation. This indicates it is a hardware medical device, not software-only.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The zLOCK Lumbar Facet Fixation System is a physical implant designed for surgical use to stabilize the spine as an adjunct to fusion. It is a mechanical device used directly on the patient's anatomy, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the zLOCK Lumbar Facet Fixation System falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
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 disc disease at a single level from L3 to L5 in skeletally mature patients who have failed conservative care.
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, L3 to L5
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)
Non-Clinical Performance Testing:
- Screw Testing per ASTM F543:
- Static axial pullout test
- Torsional strength test
- Insertion and removal tests
- Modular Spacer Testing per ASTM F2077:
- Static and dynamic axial compression
- Static and dynamic compression-shear
- Biomechanical study in cadaveric specimens
- Finite Element Analysis to evaluate shear forces
Clinical Data:
A prospective, multi-center single arm interventional study outside the United States was presented. Patients implanted with the zLOCK Lumbar Facet Fixation System Modular Spacer were evaluated using radiographic and CT evaluations, safety data, and patient reported outcomes (Oswestry Disability Index and visual analog scale for back and leg pain). For the proposed indications for use, the clinical data on the zLOCK device supports there are no increased safety or effectiveness concerns compared to predicates when used for lumbar facet fixation.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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April 18, 2024
ZygoFix, Ltd. % Justin Eggleton Vice President MCRA, LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K240085
Trade/Device Name: zLOCK Lumbar Facet Fixation System Regulatory Class: Unclassified Product Code: MRW Dated: March 21, 2024 Received: March 22, 2024
Dear Justin 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.
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).
Sincerely,
Image /page/1/Picture/6 description: The image contains the text "Colin O'neill -S" in a simple, sans-serif font. The text is arranged vertically, with "Colin" on the top line and "O'neill -S" on the bottom line. To the right of the text is a faded logo that appears to be "FDA".
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
2
Indications for Use
Submission Number (if known)
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 disc 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)
Prescription Use (Part 21 CFR 801 Subpart D)
he-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Trade Name: | zLOCK Lumbar Facet Fixation System |
|---|---|
| Manufacturer: | Zygofix, Ltd. |
| 17 T'helet St. | |
| Misgay Business Park | |
| Misgay M.P. | |
| 2017400, Israel | |
| Sponsor Contact: | Ofer Levy |
| Chief Executive Officer | |
| Prepared by: | Justin Eggleton |
| MCRA, LLC | |
| 803 7th Street, NW, 3rd Floor | |
| Washington, DC 20001 | |
| Office: 202.552.5800 | |
| Date Prepared: | March 7, 2024 |
| Classification: | Unclassified |
| Product Codes: | MRW; System, Facet Screw Spinal Device |
| Primary Predicate: | PrimaLOK Facet Fixation System (K102438) |
| Additional Predicate: | PMT Facet Fixation System, Lumbar (PMT FFS-LX) (K230840) |
| Reference Device: | PMT Facet Fixation System (K220951) |
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.
4
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 13 to 15 in skeletally mature patients who have failed conservative care.
Predicate Device:
The zLOCK Lumbar Facet Fixation System is substantially equivalent in indications, design principles, and performance to the following legally marketed predicate devices:
Primary Predicate: PrimaLOK Facet Fixation System (K102438) Additional Predicate: PMT Facet Fixation System, Lumbar (PMT FFS-LX) (K230840) Reference Device: PMT Facet Fixation System (K220951)
Non-Clinical 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:
- Screw Testing per ASTM F543: ●
- o Static axial pullout test
- o Torsional strength test
- Insertion and removal tests o
- Modular Spacer Testing per ASTM F2077:
- о Static and dynamic axial compression
- O Static and dynamic compression-shear
- . Biomechanical study in cadaveric specimens
- Finite Element Analysis to evaluate shear forces
5
Clinical Data:
Clinical data from a prospective, multi-center single arm interventional study outside the United States was presented. Patients implanted with the zLOCK Lumbar Facet Fixation System Modular Spacer were evaluated using radiographic and CT evaluations, safety data, and patient reported outcomes (Oswestry Disability Index and visual analog scale for back and leg pain). For the proposed indications for use, the clinical data on the zLOCK device supports there are no increased safety or effectiveness concerns compared to predicates when used for lumbar facet fixation.
Substantial Equivalence:
The zLOCK Lumbar Facet Fixation System is substantially equivalent to legally marketed predicate devices in terms of its technological characteristics, intended use, and mechanical performance. The zLOCK Facet Screw is nearly identical to the primary predicate except for a minor difference in thread geometry. The zLOCK construct, consisting of a Modular Spacer with Facet Screw, has the same principles of operation as the predicate devices.
Conclusion:
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.