(19 days)
Not Found
No
The 510(k) summary describes a mechanical fixation system and does not mention any AI or ML components or functionalities.
No
The device is a cannulated fixation system, indicated for the fixation of bone fractures and fusions, which are structural and mechanical interventions rather than therapeutic (e.g., drug delivery, radiation therapy).
No
Explanation: The device is a cannulated fixation system intended for fixation of fractures and non-unions, as well as arthrodesis and osteotomies. It is a surgical implant used for treatment, not for diagnosing conditions.
No
The device description explicitly states it includes cannulated stainless screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the fixation of bone fractures and joints within the body. This is a surgical/implantable device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details cannulated stainless steel screws, which are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the ExsoMed InFrame™ Cannulated Fixation System is a surgical implant device, not an IVD.
N/A
Intended Use / Indications for Use
The ExsoMed InFrame™ Cannulated Fixation System is intended for fixation of intra-articular fractures and non-unions of small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metatarsals, metatarsals, 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 to INnate™ Cannulated Screw System. The InFrame™ Cannulated Fixation System includes cannulated stainless screws with a diameter of 2.0 mm and lengths ranging from 10 mm to 50 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-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.
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 information summarized in the Design Control Activities Summary demonstrates that the additional sizes meet the pre-determined 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 InFrame™ Cannulated Fixation System implants.
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 ITN Cannulated Screw System (K171558), INnate Cannulated Screw System (K183603), GEO Bone Screw System (K161904)
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
June 20, 2020
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ExsoMed, Corp. % Patricia Kontoudis Specialist, Regulatory Affairs Regulatory and Quality Solutions, LLC 2790 Mosside Blvd. Suite 800 Monroeville, Pennsylvania 15146
Re: K201430
Trade/Device Name: InFrame™ Cannulated Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: May 28, 2020 Received: June 1, 2020
Dear Patricia Kontoudis:
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.
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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 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 (OS) 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, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201430
Device Name
InFrame™ Cannulated Fixation System
Indications for Use (Describe)
The ExsoMed InFrame™ Cannulated Fixation System is intended for fixation of intra-articular fractures and non-unions of small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metatarsals, metatarsals, 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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4. 510(k) Summary
| Manufacturer: | ExsoMed, Corp. |
|---|---|
| 135 Columbia | |
| Aliso Viejo, CA 92656 | |
| Contact: | Mr. Jung Chang |
| Director of Engineering | |
| Phone: (619) 823-5775 | |
| jchang@exsomed.com | |
| Prepared By: | Ms. Patricia Kontoudis |
| Specialist, Regulatory Affairs | |
| Regulatory and Quality Solutions LLC | |
| 2790 Mosside Blvd, Suite 800 | |
| Monroeville, PA 15146 | |
| Phone: (443) 722-0126 | |
| pkontoudis@rqteam.com | |
| Date Prepared: | May 28, 2020 |
| Device Trade Name: | InFrame™ Cannulated Fixation 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 InFrame™ Cannulated Fixation 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 to |
| INnate™ Cannulated Screw System. The InFrame™ Cannulated | |
| Fixation System includes cannulated stainless screws with a | |
| diameter of 2.0 mm and lengths ranging from 10 mm to 50 mm. | |
| Predicate Devices: | ExsoMed ITN Cannulated Screw System (K171558) (Primary) |
| INnate Cannulated Screw System (K183603) | |
| GEO Bone Screw System (K161904) | |
| Technology Comparison | |
| and Non-Clinical | |
| Performance Testing: | The ExsoMed InFrame™ Cannulated Fixation System has |
| differing specific geometry from the predicates but is | |
| manufactured from similar materials and has similar lengths, | |
| diameters and thread profiles as the predicate bone screws. The | |
| information summarized in the Design Control Activities | |
| Summary demonstrates that the additional sizes meet the pre- | |
| determined 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 InFrame™ | |
| Cannulated Fixation System implants. |
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InFrame™ Cannulated Fixation System is equivalent to the Conclusion: predicate devices with respect to intended use, materials, design, method of fixation, and performance characteristics. demonstrated that the the ExsoMed InFrame™ All Cannulated Fixation System performs similarly to the predicate device and is substantially equivalent.