(42 days)
Not Found
No
The summary describes a mechanical implant (plate and screws) for spinal fusion and mentions only mechanical testing. There is no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes
The device is intended to provide immobilization as an adjunct to fusion for treating various spinal conditions such as fractures, tumors, degenerative disc disease, and deformities, which directly addresses medical conditions.
No
The Z-Span Plate System is a medical device intended for immobilization as an adjunct to fusion in the treatment of various spinal conditions. It is described as a supplemental fixation device rather than a tool for diagnosis.
No
The device description explicitly states that the Z-Span Plate System consists of physical components (plates and screws) made of titanium alloy, which are implanted into the spine. 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:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion and stabilization. It is used in vivo (within the body) to provide structural support.
- Device Description: The device is described as a "supplemental fixation device consisting of a variety of shapes and sizes of one-level lumbar and sacral plates and screws." These are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is a surgical implant used inside the body.
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 lumbar spine (L1-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 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
Product codes
KWQ
Device Description
The Z-Span Plate System is supplemental fixation device consisting of a variety of shapes and sizes of one-level lumbar and sacral plates and screws. The plates attach to the 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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L1-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
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 as or better than the predicate device and is therefore substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
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/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, possibly suggesting care and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 22, 2016
Zavation, LLC Mr. Frankie Cummins Engineer 220 Lakeland Parkway Flowood, Mississippi 39232
Re: K160362
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: February 8, 2016 Received: February 9, 2016
Dear Mr. 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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160362
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 great vessels in the treatment of the lumbar spine (L1-L5) or via the anterior approach below 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 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
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) |
|X Prescription Use (Part 21 CFR Subbart Di ounter Use (21 CFR 801 Suppart C)
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510K Summary
| Date: | Feb 08, 2016 |
|---|---|
| Submitter: | Zavation, 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: | New device |
Device Description:
The Z-Span Plate System is supplemental fixation device consisting of a variety of shapes and sizes of one-level lumbar and sacral plates and screws. The plates attach to the 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 lumbar spine (L1-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:
Primary: Synthes, Antegra System (K063158) Additional: Orthofix, Skyhawk Plate System (K140260)
Technological Characteristics:
The technological characteristics including material, design and performance 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 as 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 is as safe, as effective, and performs as well as the predicate devices. The Z-Span Plate System does not raise new safety and effectiveness questions.