ExsoMed INnate NanoTM Lag Screw System

K220892 · Exsomed Corp. · HWC · Apr 27, 2022 · Orthopedic

Device Facts

• Record ID: K220892
• Device Name: ExsoMed INnate NanoTM Lag Screw System
• Applicant: Exsomed Corp.
• Product Code: HWC · Orthopedic
• Decision Date: Apr 27, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The ExsoMed INnate Nano™ Lag Screw System consists of cannulated stainless steel screws designed for orthopedic fixation. The system is an expansion of the InFrame™ Cannulated Fixation System, providing additional sizes (1.5mm diameter; 6mm to 26mm lengths) and geometries. Used by surgeons in clinical settings for bone fixation, arthrodesis, and osteotomies. The device functions as a mechanical fastener to stabilize bone fragments or joints, promoting healing. Surgeons select appropriate screw sizes based on patient anatomy and fracture type. The system provides mechanical stability to the fracture site, potentially improving patient outcomes by facilitating bone union and joint fusion.

Clinical Evidence

Bench testing only. Mechanical strength, screw fixation performance, and usability were evaluated using engineering analysis and testing per ASTM F543 standards.

Technological Characteristics

Cannulated stainless steel bone screws; 1.5mm diameter; 6mm to 26mm lengths. Mechanical fixation principle. Tested per ASTM F543 for mechanical strength and fixation performance.

Indications for Use

Indicated for fixation of intra-articular and extra-articular fractures, non-unions of small bones/fragments, arthrodesis of small joints, bunionectomies, and osteotomies in patients requiring small bone fixation (e.g., scaphoid, carpal, metacarpal, tarsal, metatarsal, patella, ulnar styloid, capitellum, radial head/styloid).

Regulatory Classification

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.

Predicate Devices

• ExsoMed InFrame Cannulated Fixation System (K201430)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | <span style="font-size: 16px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | □ |

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# 510(k) Summary

| Manufacturer: | ExsoMed, Corp.<br>135 Columbia<br>Suite 201<br>Aliso Viejo, CA 92656 |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Reinhold Toerek<br>Director of Regulatory & Quality<br>Phone: [phone]<br>[e-mail] |
| Prepared By: | Mr. Reinhold Toerek<br>Director of Regulatory & Quality<br>Phone: [phone]<br>[e-mail] |
| 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<br>Fixation Fastener<br>Class II |
| Product Codes: | HWC |
| Indications for Use: | The ExsoMed INnate Nano™ Lag Screw System is intended<br>for fixation of intra-articular and extra-articular fractures and<br>non-unions of small bones and small bone fragments;<br>arthrodesis of small joints; bunionectomies and osteotomies,<br>including scaphoid and other carpal bones, metacarpals,<br>tarsals, metatarsals, patella, ulnar styloid, capitellum, radial<br>head and radial styloid. |
| Device Description: | The purpose of this Special 510(k) is to add additional sizes<br>and geometry to InFrame™ Cannulated Fixation System.<br>The ExsoMed INnate Nano Lag Screw System includes |
| | cannulated stainless screws with a diameter of 1.5mm and<br>lengths ranging from 6 mm to 26 mm. |
| Predicate Devices: | ExsoMed InFrame Cannulated Fixation System (K201430) |
| Technology<br>Comparison and Non-<br>Clinical Performance<br>Testing | The ExsoMed Innate Nano Lag Screw is similar to the<br>predicate (existing device) in that it is manufactured from<br>similar materials and includes similar lengths, diameters and<br>thread profiles. There are differences in geometry and<br>packaging configuration. The information summarized in the<br>Design Control Activities Summary demonstrates that the<br>additional sizes meet the predetermined acceptance criteria<br>for the verification activities. Testing, according to ASTM<br>F543, and engineering analysis were used to evaluate the<br>mechanical strength, screw fixation performance, and screw<br>usability performance of the ExsoMed INnate Nano Lag<br>Screw System implants. |
| Conclusion | The ExsoMed INnate Nano Lag Screw System is equivalent<br>to the predicate devices with respect to intended use,<br>materials, design, method of fixation, and performance<br>characteristics. All results demonstrated that the ExsoMed<br>INnate Nano Lag Screw System performs similarly to the<br>predicate device and is substantially equivalent. |

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