(30 days)
The ExsoMed INnate Nano™ Lag Screw System is intended for fixation of intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The purpose of this Special 510(k) is to add additional sizes and geometry to InFrame™ Cannulated Fixation System. The ExsoMed INnate Nano Lag Screw System includes cannulated stainless screws with a diameter of 1.5mm and lengths ranging from 6 mm to 26 mm.
This document describes the FDA 510(k) clearance for the ExsoMed INnate Nano™ Lag Screw System. This is a medical device for orthopedic fixation, not an AI/ML powered device. Therefore, the information requested about acceptance criteria, study design (sample size, data provenance, experts for ground truth, adjudication, MRMC studies, standalone performance), ground truth type, and training set details for an AI/ML device is not applicable to this document.
The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (ExsoMed InFrame Cannulated Fixation System (K201430)) based on similar indications for use, materials, design, method of fixation, and performance characteristics.
The "Technology Comparison and Non-Clinical Performance Testing" section mentions:
- Acceptance Criteria: "The information summarized in the Design Control Activities Summary demonstrates that the additional sizes meet the predetermined acceptance criteria for the verification activities." (However, the specific acceptance criteria are not detailed in this public summary.)
- Study Proving Device Meets Acceptance Criteria: "Testing, according to ASTM F543, and engineering analysis were used to evaluate the mechanical strength, screw fixation performance, and screw usability performance of the ExsoMed INnate Nano Lag Screw System implants."
In summary, based on the provided text, it's impossible to create the table and answer the detailed questions regarding AI/ML device performance validation as the device is a mechanical orthopedic implant.
If this was an AI/ML powered device, the information would typically be found in detailed performance studies submitted as part of the 510(k), often in the "Performance Evaluation - Clinical" or "Performance Evaluation - Non-Clinical" sections, which are not fully provided in this public summary.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the date April 27, 2022. The text is in a simple, sans-serif font. The date is written out in full, with the month, day, and year clearly visible. The text is centered and takes up most of the image.
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 and Human Services logo on the left and the FDA acronym and name on the right. The Department of Health and Human Services logo is a stylized human figure, while the FDA acronym and name are written in blue, with the acronym in a square.
ExsoMed Corp. Reinhold Toerek Director of QA/RA 135 Columbia, Suite 201 Aliso Viejo, California 92656
Re: K220892
Trade/Device Name: ExsoMed INnate Nano™ Lag Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 21, 2022 Received: March 28, 2022
Dear Reinhold Toerek:
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
{1}------------------------------------------------
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 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,
Shumaya Ali, M.P.H. 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K220892
Device Name
ExsoMed INnate Nano™ Lag Screw System
Indications for Use (Describe)
The ExsoMed INnate Nano™ Lag Screw System is intended for fixation of intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
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) | □ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
| Manufacturer: | ExsoMed, Corp.135 ColumbiaSuite 201Aliso Viejo, CA 92656 |
|---|---|
| Contact: | Mr. Reinhold ToerekDirector of Regulatory & QualityPhone: (855) 397-6633rtoerek@exsomed.com |
| Prepared By: | Mr. Reinhold ToerekDirector of Regulatory & QualityPhone: (855) 397-6633rtoerek@exsomed.com |
| Date Prepared: | March 21, 2022 |
| Device Trade Name: | ExsoMed INnate Nano™ Lag Screw System |
| Common Name: | Screw, Fixation, Bone |
| Classification: | 21 CFR §888.3040 – Smooth or Threaded Metallic BoneFixation FastenerClass II |
| Product Codes: | HWC |
| Indications for Use: | The ExsoMed INnate Nano™ Lag Screw System is intendedfor fixation of intra-articular and extra-articular fractures andnon-unions of small bones and small bone fragments;arthrodesis of small joints; bunionectomies and osteotomies,including scaphoid and other carpal bones, metacarpals,tarsals, metatarsals, patella, ulnar styloid, capitellum, radialhead and radial styloid. |
| Device Description: | The purpose of this Special 510(k) is to add additional sizesand geometry to InFrame™ Cannulated Fixation System.The ExsoMed INnate Nano Lag Screw System includes |
| cannulated stainless screws with a diameter of 1.5mm andlengths ranging from 6 mm to 26 mm. | |
| Predicate Devices: | ExsoMed InFrame Cannulated Fixation System (K201430) |
| TechnologyComparison and Non-Clinical PerformanceTesting | The ExsoMed Innate Nano Lag Screw is similar to thepredicate (existing device) in that it is manufactured fromsimilar materials and includes similar lengths, diameters andthread profiles. There are differences in geometry andpackaging configuration. The information summarized in theDesign Control Activities Summary demonstrates that theadditional sizes meet the predetermined acceptance criteriafor the verification activities. Testing, according to ASTMF543, and engineering analysis were used to evaluate themechanical strength, screw fixation performance, and screwusability performance of the ExsoMed INnate Nano LagScrew System implants. |
| Conclusion | The ExsoMed INnate Nano Lag Screw System is equivalentto the predicate devices with respect to intended use,materials, design, method of fixation, and performancecharacteristics. All results demonstrated that the ExsoMedINnate Nano Lag Screw System performs similarly to thepredicate device and is substantially equivalent. |
{4}------------------------------------------------
N/A