(208 days)
No
The summary describes a physical implant device made with additive manufacturing and tested for mechanical properties. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for fixation of bone fractures, arthrodesis, and bone grafts, which addresses a medical condition or ailment.
No
The device is indicated for fixation of bone fractures, arthrodesis, and bone grafts, which are treatment or support functions, not diagnostic.
No
The device description explicitly states the device is a physical implant made from titanium alloy using additive manufacturing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "maintenance of alignment and fixation of bone fractures, arthrodesis, and bone grafts." This describes a surgical implant used directly on the patient's body to support bone structure.
- Device Description: The description details a physical implant made from titanium alloy, designed for surgical procedures involving bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of these specimens.
Therefore, the restor3d Pin Implants are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
restor3d Pin Implants are indicated for maintenance of alignment and fixation of bone fractures, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
restor3d pin implants are made from implant grade titanium alloy using an additive manufacturing process and possess a porous surface structure of unique topology. Pin implants are designed for use in a variety of surgical procedures including fixation of fractures, osteotomies, arthrodesis and as bone graft in the presence of additional immobilization. The pin implants are offered in a range of diameters, permitting surgeons to choose a relevant size for the affected anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone fractures, osteotomies, arthrodesis, and bone grafts
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:
- Bending Testing
- Shear Testing
- Pullout Testing
No new questions of safety or effectiveness were identified during device testing; therefore, the restor3d Pin Implants are considered substantially equivalent to the predicate devices.
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.
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
January 4, 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
restor3d Lexi Lewis Director of Extremity 311 West Corporation Street Durham, North Carolina 27701
Re: K211789
Trade/Device Name: restor3d Pin Implants Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: December 3, 2021 Received: December 7, 2021
Dear Ms. Lewis:
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, MBE 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
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Indications for Use
510(k) Number (if known) K211789
Device Name restor3d Pin Implants
Indications for Use (Describe)
restor3d Pin Implants are indicated for maintenance of alignment and fixation of bone fractures, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
| 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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510(k) Summary
510(k) Number: K211789
Date Prepared: December 3, 2021
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
- A. 510(k) Submitter: restor3d, inc. 311 W. Corporation St. Durham, NC 27701
- B. Primary Correspondent: Lexi Lewis Director of Extremity 317-287-4311 lexi@restor3d.com
- C. Device Information:
| Trade Name: | restor3d Pin Implant |
|---|---|
| Common Name: | fixation, pin, smooth |
-
D. Classification:
Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulation Class: Class II Product Code: HTY -
E. Predicate Devices:
| Primary Predicate: | OSSIO™ Pin Product Family (K181180) |
|---|---|
| Reference Predicates: | Arthrex Bio-Pin (K050259) |
| ADI TIDAL Osteotomy Wedge (K191047) | |
| Zimmer Kirschner Wires and Steinmann Pins (K143618). |
F. Physical Description: restor3d pin implants are made from implant grade titanium alloy using an additive manufacturing process and possess a porous surface structure of unique topology. Pin
4
implants are designed for use in a variety of surgical procedures including fixation of fractures, osteotomies, arthrodesis and as bone graft in the presence of additional immobilization. The pin implants are offered in a range of diameters, permitting surgeons to choose a relevant size for the affected anatomy.
-
G. Indications for Use:
restor3d Pin Implants are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). -
H. Comparison of Characteristics / Performance Testing / Substantial Equivalence:
The restor3d Pin Implants are substantially equivalent to the predicate devices in intended use and performance specifications. 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: -
. Bending Testing
-
. Shear Testing
-
. Pullout Testing
No new questions of safety or effectiveness were identified during device testing; therefore, the restor3d Pin Implants are considered substantially equivalent to the predicate devices.
A. Lewis
Date: Dec. 3, 2021
Lexi Lewis Director of Extremity lexi@restor3d.com
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