(259 days)
No
The device description and performance studies focus on the mechanical properties and design of a physical implant system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for use in the treatment of various spinal instabilities and conditions (e.g., fracture, tumor, degenerative disc disease) as an adjunct to fusion, which qualifies it as a therapeutic device.
No
The OAKTREE Anterior Lumbar Plate and Screw System is a spinal fixation implant used in surgery, not a device designed to diagnose medical conditions.
No
The device description explicitly states that the system consists of physical implants (plates and screws) made of Titanium 6AL-4V Alloy. This indicates a hardware-based medical device, not a software-only one.
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 and Intended Use: The provided information clearly describes the OAKTREE Anterior Lumbar Plate and Screw System as a surgical implant used to stabilize the spine during fusion procedures. It is a physical device implanted into the body, not a device that analyzes biological samples.
The description focuses on the mechanical properties, materials, and surgical application of the device, which are characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The OAKTREE 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 spine, spinal stenosis, or a failed previous spine surgery.
Product codes
KWQ
Device Description
The OAKTREE 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 OAKTREE 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 OAKTREE Anterior Lumbar Plate and Screw System was tested according to the ASTM F 1717-18.
-
- Static Compression Bending Test - ASTM F1717-18
-
- Static Tension Bending Test - ASTM F1717-18
- Static Torsional Test ASTM F1717-18 3)
-
- Dynamic Compression Bending Test - ASTM F1717-18
Static compression, Static tensile, Static torsion and Dynamic compression according to ASTM F 1717-18 was tested to demonstrate the substantial equivalency of the OAKTREE Anterior Lumbar Plate and Screw System to the predicate devices.
Bench testing to evaluate the mechanical properties of the OAKTREE Anterior Lumbar Plate and Screw System showed an equivalent mechanical value as predicate marketed devices.
- Dynamic Compression Bending Test - ASTM F1717-18
Key Metrics
Not Found
Predicate Device(s)
FIXXSURE™ Anterior Lumbar Plate and Screw System 1) (K211932), AccelFix Lumbar Plate System (K192481)
Reference Device(s)
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
December 7, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
Oak Tree Engineering, LLC. Douglas Neary President 419 Main Street, #242 Huntington Beach, California 92648
Re: K220843
Trade/Device Name: OAKTREE 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: November 1, 2022 Received: November 7, 2022
Dear Douglas 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/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
1
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 (QS) 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 -S
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) K220843
Device Name
OAKTREE Anterior Lumbar Plate and Screw System
Indications for Use (Describe)
The OAKTREE 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 spine, spinal stenosis, or a 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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Image /page/3/Picture/0 description: The image shows the logo for Oak Tree Engineering. The logo includes the text "OAK TREE ENGINEERING" and an image of a tree. Above the company name is the text "K220843" and "Page 1 of 3".
510(k) SUMMARY
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 |
|-----------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Douglas W. Neary
douglaswneary@aol.com |
| Date | March 16, 2022 |
2. Device Identification
| Trade Name: | OAKTREE 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 OAKTREE Anterior Lumbar Plate and Screw System has undergone a comprehensive battery of non-clinical testing, including chemical, physical. The testing supports a determination of substantial equivalence. The OAKTREE Anterior Lumbar Plate and Screw System met all pre-defined acceptance criteria in tests where it was compared to either the predicate or reference device and was found to not 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 OAKTREE Anterior Lumbar Plate and Screw System is substantially equivalent to the following predicate(s):
- Primary Predicate Device: FIXXSURE™ Anterior Lumbar Plate and Screw System 1) (K211932)
-
- Additional Predicate Device: AccelFix Lumbar Plate System (K192481)
FIXXSURE™ has been licensed through L&K BIOMED CO., LTD. Reference is made to K192481, AccelFix Lumbar Plate System, the approved predicate and manufacturer for the FIXXSURE™ Anterior Lumbar Plate and Screw System (K211932).
4
OAKTREE product information and testing is submitted using the drawings approved under K211932, including the same material of manufacture, manufacturing processes and manufacturer (L&K), changing only the ownership of the drawings and the model and part numbers for identification purposes.
4 Materials
OAKTREE Anterior Lumbar Plate and Screw System is manufactured from Ti-6A1-4V ELI titanium alloy (ASTM F136). This this is the same material used in the predicate devices.
ട. Description of the Device
The OAKTREE 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 OAKTREE 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 OAKTREE 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 OAKTREE Anterior Lumbar Plate and Screw System was tested according to the
ASTM F 1717-18.
-
- Static Compression Bending Test - ASTM F1717-18
-
- Static Tension Bending Test - ASTM F1717-18
- Static Torsional Test ASTM F1717-18 3)
-
- Dynamic Compression Bending Test - ASTM F1717-18
Static compression, Static tensile, Static torsion and Dynamic compression according to ASTM F 1717-18 was tested to demonstrate the substantial equivalency of the OAKTREE Anterior Lumbar Plate and Screw System to the predicate devices.
Bench testing to evaluate the mechanical properties of the OAKTREE Anterior Lumbar Plate and Screw System showed an equivalent mechanical value as predicate marketed devices.
5
Image /page/5/Picture/0 description: The image shows the logo for Oak Tree Engineering. The logo includes a tree on the left side of the image. To the right of the tree are the words "OAK TREE ENGINEERING". Above the company name is the text "K220843" and "Page 3 of 3".
8. Summary of Technology Characteristics
OAKTREE 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:
OAKTREE 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
The information presented demonstrates the substantial equivalency of the OAKTREE Anterior Lumbar Plate and Screw System to the predicate devices.