(30 days)
Not Found
No
The summary describes a mechanical fixation device (screws) and mentions only mechanical testing, with no indication of software, image processing, or AI/ML algorithms.
Yes
The device is intended for fixation of intra-articular fractures and non-unions, and arthrodesis, which are therapeutic interventions.
No
The device is a system of lag screws intended for fixation of intra-articular fractures and non-unions, and arthrodesis. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it includes "cannulated stainless screws," which are physical hardware components, 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 perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of the ExsoMed INnate Nano Lag Screw System clearly indicate it is a surgical implant used for the fixation of bones and joints. It is a physical device inserted into the body, not a device used to analyze samples outside the body.
The information provided focuses on the mechanical properties and surgical application of the screw system, which is consistent with a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and small bone fragments; small joints; scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
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)
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. All results demonstrated that the ExsoMed INnate Nano Lag Screw System performs similarly to the predicate device and is substantially equivalent.
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.
ExsoMed InFrame Cannulated Fixation System (K201430)
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.
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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
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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
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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) | □ |
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510(k) Summary
| Manufacturer: | ExsoMed, Corp.
135 Columbia
Suite 201
Aliso Viejo, CA 92656 |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Reinhold Toerek
Director of Regulatory & Quality
Phone: (855) 397-6633
rtoerek@exsomed.com |
| Prepared By: | Mr. Reinhold Toerek
Director of Regulatory & Quality
Phone: (855) 397-6633
rtoerek@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 Bone
Fixation Fastener
Class II |
| Product Codes: | HWC |
| Indications for Use: | The ExsoMed INnate Nano™ Lag Screw System is intended
for fixation of intra-articular and extra-articular fractures and
non-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, radial
head and radial styloid. |
| Device Description: | 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. |
| Predicate Devices: | ExsoMed InFrame Cannulated Fixation System (K201430) |
| Technology
Comparison and Non-
Clinical Performance
Testing | The ExsoMed Innate Nano Lag Screw is similar to the
predicate (existing device) in that it is manufactured from
similar materials and includes similar lengths, diameters and
thread profiles. There are differences in geometry and
packaging configuration. The information summarized in the
Design Control Activities Summary demonstrates that the
additional sizes meet the predetermined acceptance criteria
for the verification activities. 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. |
| Conclusion | The ExsoMed INnate Nano Lag Screw System is equivalent
to the predicate devices with respect to intended use,
materials, design, method of fixation, and performance
characteristics. All results demonstrated that the ExsoMed
INnate Nano Lag Screw System performs similarly to the
predicate device and is substantially equivalent. |
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