(728 days)
Not Found
No
The summary describes a physical implant made of metal, intended for surgical use. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is an implant intended to treat medical conditions such as degenerative and post-traumatic arthritis, hallux rigidus, and unstable or painful MTP joints by replacing damaged articulating surfaces. These are therapeutic uses.
No
Explanation: The provided text explicitly states that the restor3d MTP Implant is "intended for use as a hemi-arthroplasty implant" and "designed to replace damaged articulating surface." It describes the device as a treatment for various conditions rather than a tool for diagnosis.
No
The device description clearly states it is a "sterile, single use implant grade metal device" and describes its physical composition and intended use as 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 taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The restor3d MTP Implant is a physical implant designed to be surgically placed inside the body to replace a damaged joint. It is a prosthetic device, not a diagnostic tool.
- Intended Use: The intended use is to treat conditions like arthritis and hallux rigidus by replacing a joint, not to diagnose these conditions through laboratory testing.
The provided text clearly describes a surgical implant, which falls under the category of medical devices used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The restor3d MTP Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is a single use implant intended to be press fit with optional use of bone cement.
Product codes (comma separated list FDA assigned to the subject device)
KWD
Device Description
The restor3d MTP Implant is a sterile, single use implant grade metal device, available in varied articulating surface coverages. The restor3d MTP implant is designed to replace damaged articulating surface of the first metatarsal distal head. The device is intended for the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head. This implant can also be used in the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The implant is a single use product intended to be press fit, with optional use of bone cement. The restor3d MTP Implant is comprised of a single laser powder bed fusion (LPBF) printed cobalt-chromium alloy (Co28Cr6Mo) part. The external surface of the implant that is intended to be in contact with the phalanx is mirror polished.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first metatarsophalangeal joint, first metatarsal distal head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
- Comparative monotonic compression-subsidence test
- Monotonic compression test
- Comparative monotonic bending-pullout test
- Monotonic bending test
- Surface roughness analysis
- Monotonic shear, shear fatigue, and abrasion tests for modified metallic surfaces
- Gravimetric and comparative particulate analysis tests
No new questions of safety or effectiveness were identified during device testing; therefore, the restor3d MTP Implant 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.
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
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.
0
May 25, 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 logo 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, Inc. Jillian Udell Product Manager 311 W Corporation St Durham, North Carolina 27701
Re: K201393
Trade/Device Name: restor3d MTP Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe Joint Phalangeal (Hemi-Toe) Polymer Prosthesis Regulatory Class: Class II Product Code: KWD Dated: May 16, 2022 Received: May 18, 2022
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 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.
Ting Song, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty 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) K201393
Device Name restor3d MTP Implant
Indications for Use (Describe)
The restor3d MTP Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is a single use implant intended to be press fit with optional use of bone cement.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510(k) Page 5-1 of 3
510(k) Summary
510(k) Number: K201393
Date Prepared: May 16, 2022
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: Jillian Udell Product Manager 984-888-0593 jillian@restor3d.com
| C. | Device Information: | ||
|---|---|---|---|
| Trade Name: | restor3d MTP Implant | ||
| Common Name: | MTP Arthroplasty Implant | ||
| D. | Classification: | MTP Arthroplasty Implant | |
| 21 CFR 888.3730 |
E. Predicate Device(s): Metatarsal Decompression Implant™, K090127
F. Physical Description:
The restor3d MTP Implant is a sterile, single use implant grade metal device, available in varied articulating surface coverages. The restor3d MTP implant is designed to replace damaged articulating surface of the first metatarsal distal head. The device is intended for the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head. This implant can also be used in the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The implant is a single use product intended to be press fit, with optional use of bone cement.
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The restor3d MTP Implant is comprised of a single laser powder bed fusion (LPBF) printed cobalt-chromium alloy (Co28Cr6Mo) part. The external surface of the implant that is intended to be in contact with the phalanx is mirror polished.
Indications for Use: G.
The restor3d MTP Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is a single use implant intended to be press fit, with optional use of bone cement.
Comparison of Characteristics / Performance Testing / Substantial H. Equivalence:
The restor3d MTP Implant is substantially equivalent to the predicate device (Metatarsal Decompression Implant™, K090127) in intended use and important physical and performance specifications. The devices have similar design / physical characteristics (i.e., similar articulating surface, presence of stem) and similar indications for use. The proposed restor3d device was subjected to the following performance tests to support the assertion of substantial equivalence:
- Comparative monotonic compression-subsidence test
- Monotonic compression test
- Comparative monotonic bending-pullout test
- Monotonic bending test
- Surface roughness analysis
- Monotonic shear, shear fatigue, and abrasion tests for modified metallic surfaces
- Gravimetric and comparative particulate analysis tests
No new questions of safety or effectiveness were identified during device testing; therefore, the restor3d MTP Implant is considered substantially equivalent to the predicate device.
Piliin Udell 05/16/2021
Jillian Udell Product Manager
311 W Corporation St Durham, NC 27701 984-888-0593
restor3d, inc.
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K201393 Page 3 of 3
Traditional 510(k) Page 5-3 of 3
984-888-0593 jillian@restor3d.com
311 W Corporation St Durham, NC 27701 984-888-0593