(93 days)
Not Found
No
The 510(k) summary describes a purely mechanical implant for bone graft fixation and makes no mention of AI or ML technology in its description, intended use, or performance studies.
Yes
The device is used for bone graft fixation in ACL and PCL reconstruction, which is a therapeutic intervention.
No
The device is an implant used for fixation in ligament reconstruction, not for identifying or diagnosing a condition.
No
The device description clearly states it is a sterile, single-use implant made of metallic alloys, indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes the restor3d Metallic Interference Screw as a sterile, single-use implant used to fix bone grafts during knee reconstruction surgery. It is a physical device implanted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, providing diagnostic information, or any of the typical characteristics of an IVD.
The device is an implantable orthopedic device.
N/A
Intended Use / Indications for Use
The restor3d Metallic Interference Screw is used to provide bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The proposed restor3d Metallic Interference Screw is a sterile, single use implant available in either titanium alloy or cobalt chrome alloy. The device is cannulated to allow a guidewire to assist with placement of the screw into the bone tunnel. The screw is used to maintain fixation of bone-tendon-bone grafts in orthopedic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
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 subjected to the following performance tests to support the assertion of safety and substantial equivalence to the predicate devices:
- Pullout Strength
- Insertion Torque
- Biocompatibility [ISO 10993-1]
- Pyrogenicity [ANSI/AAMI ST72]
- Sterilization [ISO 11137-1, ISO 11137-2, and AAMI TIR33]
No new questions of safety or effectiveness were identified during device testing; therefore, the restor3d Metallic Interference Screw 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.
Conmed EZ-Start Interference Screw (K182955), Smith&Nephew CANNU-FLEX SILK Interference Screw (K921481)
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.
Not Found
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
March 19, 2020
Image /page/0/Picture/1 description: The image contains 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 includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
restor3D Nathan Evans VP of Technology and Strategy 311 W Corporation St Durham, North Carolina 27701
Re: K193491/S001
Trade/Device Name: restore3d Metallic Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: December 16, 2019 Received: December 17, 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
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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.
Jesse Muir, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K193491
Device Name restor3d Metallic Interference Screw
Indications for Use (Describe)
The restor3d Metallic Interference Screw is used to provide bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
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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restor3d, inc.
510(k) Summary
510(k) Number:
Date Prepared: 3/13/2020
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: Nathan Evans, Ph.D. VP of Technology and Strategy 404-660-4418 nathan@restor3d.com
| C. | Device Information: | |
|---|---|---|
| Trade Name: | restor3d Metallic Interference Screw | |
| Common Name: | Interference Screw | |
| D. | Classification: | Smooth or threaded metallic bone fixation fastener |
| 21 CFR 888.3040 |
- E. Predicate Device(s): Conmed EZ-Start Interference Screw (K182955) Smith&Nephew CANNU-FLEX SILK Interference Screw (K921481)
- F. Physical Description: The proposed restor3d Metallic Interference Screw is a sterile, single use implant available in either titanium alloy or cobalt chrome alloy. The device is cannulated to allow a guidewire to assist with placement of the screw into the bone tunnel. The screw is used to maintain fixation of bone-tendon-bone grafts in orthopedic procedures.
- G. Indications for Use:
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The restor3d Metallic Interference Screw is used to provide bone-tendonbone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
Comparison of Characteristics / Performance Testing / Substantial H. Equivalence:
The restor3d Metallic Interference Screw is substantially equivalent to the predicate devices (Conmed EZ-Start Interference Screw, K182955, and Smith&Nephew CANNU-FLEX SILK Interference Screw, K921481) in intended use and important physical and performance specifications. The devices have similar design / physical characteristics (i.e., similar sizing and mechanism of fixation) and the same indications for use. In addition, the restor3d Metallic Interference Screw is available with a rounded head feature, and may be provided in packaging which differs from the predicate devices. The proposed restor3d device was subjected to the following performance tests to support the assertion of safety and substantial equivalence to the predicate devices:
- Pullout Strength
- Insertion Torque
- Biocompatibility [ISO 10993-1] ●
- Pyrogenicity [ANSI/AAMI ST72] ●
- Sterilization [ISO 11137-1, ISO 11137-2, and AAMI TIR33] ●
No new questions of safety or effectiveness were identified during device testing; therefore, the restor3d Metallic Interference Screw is considered substantially equivalent to the predicate device.
Nattungvana 3/13/2020
Nathan Evans, Ph.D. VP of Technology and Strategy 404-660-4418 nathan@restor3d.com