(35 days)
No
The 510(k) summary describes a mechanical implant system (plates and screws) for spinal fixation. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies are bench tests evaluating mechanical properties.
Yes
The device is described as an "aid in spinal fixation" for various spinal instabilities, indicating its use in treating medical conditions directly, which aligns with the definition of a therapeutic device.
No
The device is described as an Anterior Lumbar Plate and Screw System, which is an implant used for spinal fixation, not for diagnosing conditions.
No
The device description clearly states that the FIXXSURE™ Anterior Lumbar Plate and Screw System consists of physical implants (plates and screws) made of Titanium 6AL-4V Alloy, which are hardware components.
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 system used for spinal fixation in the lumbar and lumbosacral spine. This is a therapeutic device used in vivo (within the body) to treat structural instability.
- Device Description: The description details physical implants (plates and screws) made of titanium alloy, designed for surgical implantation.
- 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 in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The FIXXSURE™ Anterior Lumbar Plate and Screw System is indicated for use via the anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc conformed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.
Product codes
KWQ
Device Description
The FIXXSURE™ Anterior Lumbar Plate and Screw System's implants are a lumbar Plate System intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). The FIXXSURE™ Anterior Lumbar Plate and Screw System consists of a variety of shapes and sizes of plates and screws. The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of the screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and lumbosacral (1-S1) spine
Indicated Patient Age Range
Not Found
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
The FIXXSURE™ Anterior Lumbar Plate and Screw System was tested according to ASTM F 1717-18.
-
- Static Compression Bending Test ASTM F1717-18
- Static Tension Bending Test ASTM F1717-18 2)
-
- Static Torsional Test - ASTM F1717-18
- Dynamic Compression Bending Test ASTM F1717-18 4)
Static compression, Static tensile, Static torsion and Dynamic compression testing was performed as described in ASTM F 1717-18 to demonstrate the substantial equivalence of the FIXXSURE™ Anterior Lumbar Plate and Screw System to the predicate devices. Bench testing to evaluate the mechanical properties of the FIXXSURE™ Anterior Lumbar Plate and Screw System showed similar or higher mechanical value than the predicate marketed 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.
0
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Oak Tree Engineering, LLC. % Douglas W. Neary Consultant 419 Main Street, #242 Huntington Beach, CA 92648
Re: K211932
Trade/Device Name: FIXXSURE™ Anterior Lumbar Plate and Screw System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 5, 2021 Received: June 22, 2021
Dear Douglas W. Neary:
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/cdrl/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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR
July 27, 2021
1
- for 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/cdrl-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.
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
2
Indications for Use
510(k) Number (if known) K211932
Device Name
FIXXSURE™ Anterior Lumbar Plate and Screw System
Indications for Use (Describe)
The FIXXSURE™ Anterior Lumbar Plate and Screw System is indicated for use via the anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc conformed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.
| 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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Image /page/3/Picture/0 description: The image is a logo for Oak Tree Engineering. The logo features a white oak tree on the left side of the image. To the right of the tree, the words "OAK TREE ENGINEERING" are written in white, with the word "ENGINEERING" in a smaller font size. Below that, the words "Project & Process Engineering" are written in an even smaller font size. The background of the logo is a dark blue color.
510(k) SUMMARY
K211932 Pg. 1 of 3
The following 510(k) summary is being submitted as required by 21 CFR 807.92:
- 1 Manufacturer
| Submitter: | Oak Tree Engineering, LLC. |
|---|---|
| 419 Main Street, #242, Huntington Beach, California 92648. | |
| Phone: 805-797-3003 | |
| Website: https://www.oaktreellc.com | |
| Contact Person: | Douglas W. Neary |
| douglaswneary@aol.com | |
| Date | April 5, 2021 |
2. Device Identification
| Trade Name: | FIXXSURE™ Anterior Lumbar Plate and Screw System |
|---|---|
| Common Name: | Spinal Fixation Appliances |
| Product Code: | KWQ |
| Classification: | Class II |
| Classification | |
| Name: | Spinal intervertebral body fixation orthosis |
| Regulation No. | 21 CFR 888.3060 |
| Classification Pane | Orthopedic |
3. Predicate or legally marketed devices which are substantially equivalent.
The FIXXSURE™ Anterior Lumbar Plate and Screw System has undergone a comprehensive battery of non-clinical testing, including chemical, The testing supports a determination of substantial equivalence. The FIXXSURE™ Anterior Lumbar Plate and Screw System met all pre-defined acceptance criteria and, in tests where it was compared to either AccelFix Anterior Lumbar Plate and Screw System, the predicate or reference device, was found not to represent a new worst case. Overall, the results of the performance bench tests support the substantial equivalence of the Subject device.
The design feature and indications for use for the subject device 'FIXXSURE™ Anterior Lumbar Plate and Screw System' is substantially equivalent to the following predicate:
-
- Primary Predicate Device: AccelFix Lumbar Plate System (K192481)
4 Materials
FIXXSURE™ Anterior Lumbar Plate and Screw System is manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136). This this is the same material used in the predicate devices.
4
Image /page/4/Picture/0 description: The image is a logo for Oak Tree Engineering. The logo is set on a blue background. On the left side of the logo is a white tree. To the right of the tree is the text "OAK TREE ENGINEERING" in white, with the words "Project & Process Engineering" in a smaller font below.
న. Description of the Device
The FIXXSURE™ Anterior Lumbar Plate and Screw System's implants are a lumbar Plate System intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136).
The FIXXSURE™ Anterior Lumbar Plate and Screw System consists of a variety of shapes and sizes of plates and screws.
The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of the screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.
6. Indications for Use
The FIXXSURE™ Anterior Lumbar Plate and Screw System is indicated for use via the anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc conformed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
7. Performance -Bench testing
The FIXXSURE™ Anterior Lumbar Plate and Screw System was tested according to ASTM F 1717-18.
-
- Static Compression Bending Test ASTM F1717-18
- Static Tension Bending Test ASTM F1717-18 2)
-
- Static Torsional Test - ASTM F1717-18
- Dynamic Compression Bending Test ASTM F1717-18 4)
Static compression, Static tensile, Static torsion and Dynamic compression testing was performed as described in ASTM F 1717-18 to demonstrate the substantial equivalence of the FIXXSURE™ Anterior Lumbar Plate and Screw System to the predicate devices.
Bench testing to evaluate the mechanical properties of the FIXXSURE™ Anterior Lumbar Plate and Screw System showed similar or higher mechanical value than the predicate marketed devices.
8. Summary of Technology Characteristics
FIXXSURE™ Anterior Lumbar Plate and Screw System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.
9. Substantial Equivalence:
FIXXSURE™ Anterior Lumbar Plate and Screw System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.
10. Conclusion
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The information presented demonstrates the substantial equivalency of the FIXXSURE™ Anterior Lumbar Plate and Screw System to the predicate devices.