(200 days)
Not Found
No
The summary describes a physical implant device made of titanium alloy and its mechanical performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for internal bone fixation for fractures or osteotomies, which is a therapeutic intervention to treat a medical condition (fractures or bone deformities).
No
The device description indicates it is a medical implant used for internal bone fixation in fractures or osteotomies, not for diagnosing conditions.
No
The device description clearly states the device is a sterile, single-use medical grade titanium alloy device, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The TiDAL Osteotomy Wedges are described as sterile, single-use medical grade titanium alloy devices intended for internal bone fixation during surgery. They are implanted directly into the body to support bone fractures or osteotomies.
- Intended Use: The intended use clearly states the device is for "internal bone fractures or osteotomies in the ankle and foot" and for "use with ancillary plating fixation." This is a surgical implant, not a device used to test samples outside the body.
The information provided about the device's material, structure, intended surgical use, and performance testing (mechanical strength, wear, expulsion) all point to it being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The TiDAL Osteotomy Wedges are intended to be used for internal bone fractures or osteotomies in the ankle and foot, such as:
- · Cotton (opening wedge) osteotomies of the medial cuneiform
- · Evans lengthening osteotomies.
The TiDAL Osteotomy Wedges are intended for use with ancillary plating fixation.
The TiDAL Osteotomy Wedges are not intended for use in the spine.
Product codes
PLF
Device Description
The proposed ADI TiDAL Osteotomy Wedge is a sterile, single use medical grade titanium alloy (Ti-6Al-4V) device, available in varied footprints and heights. The ADI TiDAL Osteotomy Wedge is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as Cotton (opening) osteotomies of the medical cuneiform and Evans (lengthening) osteotomies. The TiDAL Wedge device is comprised of a single, continuous piece of titanium alloy fabricated via additive manufacturing. The ADI device has a porous structure throughout the body of the implant and a circular window for the packing of graft material, a threaded hole for insertion (Evans implant only), and a strike plate for implant positioning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle and foot
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed ADI device was subjected to the following performance tests to support the assertion of substantial equivalence:
- · Comparative functional performance testing per ASTM F2077-18, Test Methods For Intervertebral Body Fusion Devices;
- o Static compressive strength
- Dynamic compressive strength o
- Static compression shear strength o
- . Comparative wear analysis following dynamic compression
- Expulsion testing .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Integra Titanium Bone Wedge®, K131360
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 5, 2019
Additive Device, Inc. (ADI) d/b/a restor3d Nathan Evans Vice President of Technology and Strategy 311 W Corporation Street Durham, North Carolina 27701
Re: K191047
Trade/Device Name: ADI TiDAL Osteotomy Wedge Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PLF Dated: October 3, 2019 Received: October 4, 2019
Dear Nathan Evans:
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 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.
For: Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair, and Trauma 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) K191047
Device Name ADI TiDAL Osteotomy Wedge
Indications for Use (Describe)
The TiDAL Osteotomy Wedges are intended to be used for internal bone fractures or osteotomies in the ankle and foot, such as:
- · Cotton (opening wedge) osteotomies of the medial cuneiform
- · Evans lengthening osteotomies.
The TiDAL Osteotomy Wedges are intended for use with ancillary plating fixation.
The TiDAL Osteotomy Wedges are not intended for use in the spine.
| 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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Additive Device Incorporated
510(k) Summary
510(k) Number: K191047
October 31, 2019 Date Prepared:
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
- A. Submitter: Additive Device, Inc. (ADI) d/b/a restor3d 311 W Corporation St Durham, NC 27701 984-888-0593
- B. Company Contact: Nathan Evans, Ph.D. VP of Technology and Strategy 404-660-4418 nathan@restor3d.com
| C. | Device Information:
Trade Name: ADI TiDAL Osteotomy Wedge
Common Name: Osteotomy Wedge |
|----|----------------------------------------------------------------------------------------------|
| D. | Classification: Orthopedic, Bone Wedge (Class II
21 CFR 888.3030 |
- ட். Predicate Device(s): Integra Titanium Bone Wedge®, K131360
- F. Physical Description:
The proposed ADI TiDAL Osteotomy Wedge is a sterile, single use medical grade titanium alloy (Ti-6Al-4V) device, available in varied footprints and heights. The ADI TiDAL Osteotomy Wedge is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as Cotton (opening) osteotomies of the medical cuneiform and Evans (lengthening) osteotomies. The TiDAL Wedge device is comprised of a single, continuous piece of titanium alloy fabricated via additive manufacturing. The ADI device has a porous structure throughout the body of the implant and a circular window for the packing of graft material, a threaded hole for insertion (Evans implant only), and a strike plate for implant positioning.
4
-
G. Indications for Use:
The TiDAL Osteotomy Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: -
Cotton (opening wedge) osteotomies of the medial cuneiform ●
-
Evans lengthening osteotomies ●
The TiDAL Osteotomy Wedges are intended for use with ancillary plating fixation.
The TiDAL Osteotomy Wedges are not intended for use in the spine.
-
H. Performance Testing
The proposed ADI device was subjected to the following performance tests to support the assertion of substantial equivalence: -
· Comparative functional performance testing per ASTM F2077-18, Test Methods For Intervertebral Body Fusion Devices;
- o Static compressive strength
- Dynamic compressive strength o
- Static compression shear strength o
-
. Comparative wear analysis following dynamic compression
-
Expulsion testing .
l. Comparison of Characteristics / Substantial Equivalence:
Although the ADI TiDAL Osteotomy Wedge differs from the predicate in the device material, the devices have similar design / physical characteristics (i.e., porous metal implant with graft window) and the same intended use.
The ADI TiDAL Osteotomy Wedge does not raise different questions of safety or effectiveness. The ADI TiDAL Osteotomy Wedge is substantially equivalent to the predicate device (Integra Titanium Bone Wedge®, K131360).