(55 days)
Not Found
No
The 510(k) summary describes a mechanical spinal plate system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not related to data analysis or image processing.
No
The device, a Z-Span Plate System, is an implantable medical device designed to provide immobilization and supplemental fixation in spinal fusion surgeries for various conditions. It does not actively treat or diagnose a disease but rather provides structural support.
No
The device is described as a "supplemental fixation device" intended for immobilization as an adjunct to fusion in the treatment of various spinal conditions. It does not perform any diagnostic functions.
No
The device description explicitly states it consists of "thoracic, lumbar, and sacral plates and screws" made of "titanium alloy," which are physical hardware components.
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 about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The Z-Span Plate System is a surgical implant designed to provide structural support and immobilization to the spine within the body. It is used directly in surgical procedures to treat various spinal conditions.
The description clearly indicates a device used in vivo (within the living body) for surgical intervention, not for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracolumbar spine (T1-L5) or via the anterior approach below the bifurcation of the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).
The Z-Span Plate System is intended to provide immobilization as an adjunct to fusion in sketally mature patients in the treatment of the following:
- Fracture (including dislocation and subluxation)
- Tumor
- Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Pseudoarthrosis
- Spondylolysis
- Spondylolisthesis
- Scoliosis
- Lordotic deformities of the spine
- Spinal stenosis
- Failed previous spine surgery
Product codes
KWQ
Device Description
The Z-Span Plate System is supplemental fixation device consisting of a variety of shapes and sizes of thoracic, lumbar, and sacral plates and screws. The plates attach to the thoracic, lumbar, and lumbosacral spine (L1-S1). The implant components are made of titanium alloy per ASTM F-136 (Ti-6AL-4V ELi).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
thoracolumbar spine (T1-L5), lumbar and lumbosacral spine (L1-S1)
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)
Mechanical testing of the Z-Span Plate System consisting of static and dynamic axial compression bending testing and static torsion testing was conducted in accordance with ASTM F1717. Test results demonstrate that the Z-Span Plate System performs as well or better than the predicate device and is therefore substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K162824, K020244, K160362, K112484
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Zavation Medical Products LLC Frankie Cummins Engineer 220 Lakeland Parkway Flowood, Mississippi 39232
November 4, 2020
Re: K202624
Trade/Device Name: Z-Span Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 9, 2020 Received: September 10, 2020
Dear Frankie Cummins:
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.
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
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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 (OS) 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 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).
Sincerely,
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
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Indications for Use
510(k) Number (if known) K202624
Device Name
Z-Span Plate System
Indications for Use (Describe)
The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracolumbar spine (T1-L5) or via the anterior approach below the bifurcation of the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).
The Z-Span Plate System is intended to provide immobilization as an adjunct to fusion in sketally mature patients in the treatment of the following:
- · Fracture (including dislocation and subluxation)
• Tumor
· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Pseudoarthrosis
- · Spondylolysis
- · Spondylolisthesis
- · Scoliosis
- · Lordotic deformities of the spine
- · Spinal stenosis
- · Failed previous spine surgery
| 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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510K Summary
| Date: | Nov 3, 2020 |
|---|---|
| Submitter: | Zavation, Medical Products LLC |
| 220 Lakeland Parkway | |
| Flowood, MS 39232 | |
| Phone: 601-919-1119 | |
| Fax: 800-447-1302 | |
| Contact person: | Frankie Cummins |
| Type of 510(k) submission: | Traditional |
| Trade name: | Z-Span Plate System |
| Common Name: | Spinal Fixation System |
| Classification regulation/code: | 888.3060, KWQ |
| Classification name: | Spinal Intervertebral Body Fixation Orthosis |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Basis for submission: | Addition of components: added expanding lateral plate |
| options |
Device Description:
The Z-Span Plate System is supplemental fixation device consisting of a variety of shapes and sizes of thoracic, lumbar, and sacral plates and screws. The plates attach to the thoracic, lumbar, and lumbosacral spine (L1-S1). The implant components are made of titanium alloy per ASTM F-136 (Ti-6AL-4V ELi).
Indications for Use:
The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracolumbar spine (T1-L5) or via the anterior approach below the bifurcation of the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).
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The Z-Span Plate System is intended to provide immobilization and stabilization as an adjunct to fusion in skeletally mature patients in the treatment of the following:
- Fracture (including dislocation and subluxation) ●
- . Tumor
- Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Pseudoarthrosis
- Spondylolysis
- Spondylolisthesis
- Scoliosis
- Lordotic deformities of the spine
- Spinal stenosis
- Failed previous spine surgery
Predicate Device:
Zavation, Z-Span Plate System (K162824) Primary:
Additional: Synthes, Anterior Thoracolumbar Locking Plate (K020244) Zavation, Z-Span Plate System (K160362) Zavation, Zavation Spinal System (K112484)
Technological Characteristics:
The technological characteristics including material, design, performance, intended use, and indications for use of the Z-Span Plate System are consistent with those of the predicate devices.
Performance Data:
Mechanical testing of the Z-Span Plate System consisting of static and dynamic axial compression bending testing and static torsion testing was conducted in accordance with ASTM F1717. Test results demonstrate that the Z-Span Plate System performs as well or better than the predicate device and is therefore substantially equivalent to the predicate devices.
Conclusion:
Based on the similarities in materials, design, principles of function, intended use and indications, the Z-Span Plate system has been shown to be substantially equivalent to the predicate devices. Non-clinical data demonstrates the Z-Span Plate System performs as well as the predicate devices. The Z-Span Plate System does not raise new issues of safety or effectiveness questions.