(395 days)
No
The summary describes a physical implant (titanium wedge) and its intended use and performance testing. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is a surgical implant designed to correct bone deformities or facilitate fusions, but it does not treat or cure a disease or condition in the way a therapeutic device would. It is a structural aid in surgical procedures.
No
The device is described as a medical article (wedge) to be implanted during surgery for bone fractures or osteotomies, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "sterile, single use medical grade titanium alloy (Ti-6Al-4V) device," indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "internal bone fractures or osteotomies in the ankle and foot." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "sterile, single use medical grade titanium alloy device" designed for "opening and lengthening osteotomy procedures." This is a physical implant used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the restor3d Utility Wedges does not involve any such testing of bodily specimens.
Therefore, the restor3d Utility Wedges are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The restor3d Utility Wedges are intended to be used for internal bone fractures or osteotomies in the ankle and foot, such as:
- Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform or Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- Metatarsal Cuneiform osteotomies
- Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies (TMT or Lapidus)
- Hindfoot osteotomies such as Ankle fusion and Subtalar fusion
The restor3d Utility Wedges are intended for use with supplemental fixation. The restor 3d Utility Wedges are not intended for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
PLF
Device Description
The proposed Utility Wedge is a sterile, single use medical grade titanium alloy (Ti-6Al-4V) device, available in varied footprints and heights, designed for opening and lengthening osteotomy procedures of the foot, including Lapidus and Subtalar.
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 restor3d device was subject to the following benchtop performance tests to support the assertion of substantial equivalence:
- Static Compressive Strength
- Dynamic Compressive Strength
- Expulsion
No new questions of safety or effectiveness were identified during device testing; therefore, the restor3d Utility Wedge is considered substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ADI TiDAL Osteotomy Wedge, K191047, 4Web Osteotomy Truss System, K172294
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
4 Web Osteotomy Truss System, K172294
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
June 17, 2021
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
restor3d, Inc. Michaela Pigue R&D Engineer 311 W Corporation St Durham, North Carolina 27701
Re: K201314
Trade/Device Name: Restor3d Utility 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: June 10, 2021 Received: June 14, 2021
Dear Michaela Pigue:
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,
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) K201314
Device Name restor3d Utility Wedge
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
The restor3d Utility Wedges are intended to be used for internal bone fractures or osteotomies in the ankle and foot, such as:
- · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
- · Opening wedge of Medial Cuneiform or Cotton osteotomies
- · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- · Metatarsal Cuneiform osteotomies
- · Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies (TMT or Lapidus)
- · Hindfoot osteotomies such as Ankle fusion and Subtalar fusion
The restor3d Utility Wedges are intended for use with supplemental fixation. The restor 3d Utility Wedges are not intended for use in the spine.
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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510(k) Summary
510(k) Number: K201314
Date Prepared: 6/10/2021
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
- A. Submitter: restor3d, Inc. 311 W Corporation St Durham, NC 27701 984-888-0593
- B. Company Contact: Michaela Pigue R&D Engineer 984-888-0593 michaela@restor3d.com
- C. Device Information: Trade Name: restor3d Utility Wedge Common Name: Osteotomy Wedge
- D. Orthopedic, Bone Wedge Classification:
21 CFR 888.3030
Product Code: PLF
Predicate Device(s):
ADI TiDAL Osteotomy Wedge, K191047, Primary Predicate
Product Code: PLF
4Web Osteotomy Truss System, K172294, Additional Predicate
Product Code: HRS
E. Physical Description:
The proposed Utility Wedge is a sterile, single use medical grade titanium alloy (Ti-6Al-4V) device, available in varied footprints and heights, designed for opening and lengthening osteotomy procedures of the foot, including Lapidus and Subtalar.
4
F. Indications for Use:
The restor3d Utility Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform or Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- Metatarsal Cuneiform osteotomies
- . Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies (TMT or Lapidus)
. Hindfoot osteotomies such as Ankle Fusion and Subtalar Fusion The restor3d Utility Wedges are intended for use with supplemental fixation. The restor3d Utility Wedges are not intended for use in the spine.
G. Comparison of Characteristics / Performance Testing / Substantial Equivalence:
The restor3d Utility Wedge is substantially equivalent to the primary predicate device (ADI TiDAL Osteotomy Wedge, K191047) in important physical and performance specifications and the reference predicate device (4 Web Osteotomy Truss System, K172294) in intended use. The devices have similar design/physical characteristics (i.e., similar sizing and mechanism of fixation) and the same indications for use. The proposed restor3d device was subject to the following benchtop performance tests to support the assertion of substantial equivalence:
- Static Compressive Strength
- Dynamic Compressive Strength
- Expulsion
5
H. Conclusions:
No new questions of safety or effectiveness were identified during device testing; therefore, the restor3d Utility Wedge is considered substantially equivalent to the predicate device.
6/10/2021
Michaela Pigue R&D Engineer 984-888-0593 michaela@restor3d.com