Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws

K222967 · Avanti Orthopaedics, Inc. · HWC · Nov 23, 2022 · Orthopedic

Device Facts

• Record ID: K222967
• Device Name: Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
• Applicant: Avanti Orthopaedics, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Nov 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Compression Screws: The Avanti Orthopedics 2.2 mm and 2.7mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Compression Screws: The Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones and small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

Device Story

Metallic cannulated bone screws for internal fixation of fractures, fusions, osteotomies, non-unions, and malunions. Screws are cannulated to allow placement over guidewires for precise positioning in bone. Used by surgeons in clinical settings. Provides mechanical stabilization of bone fragments to facilitate healing. Manufactured from stainless steel via subtractive techniques. Available in multiple diameters (2.2mm, 2.7mm, 3.2mm, 4.0mm) and lengths (14-60mm).

Clinical Evidence

Bench testing only. Performance testing conducted per ASTM F543-17 and FDA guidance 'Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway'. All predetermined acceptance criteria were met.

Technological Characteristics

Stainless steel (ASTM F138); cannulated design for guidewire placement; self-tapping; subtractive manufacturing; headless form factor; end-user steam sterilized (132°C, 4 min exposure).

Indications for Use

Indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones and small bone fragments in adults, children (2-12 years), and adolescents (12-21 years) where growth plates are fused or will not be crossed by fixation.

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

• DePuy Synthes 2.4 mm Cannulated Screws (K161616)
• DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws (K161616)
• DePuy Synthes 2.0 mm Quick Insertion Screws (K180541)
• CAPTIVATE™ Compression Screws (K162825)

Reference Devices

• Avanti Distal Radius and Forearm System (K191118)

Submission Summary (Full Text)

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November 23, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

Avanti Orthopaedics, Inc. % Linda Braddon, CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188

Re: K222967

Trade/Device Name: Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: September 26, 2022 Received: September 27, 2022

Dear Linda Braddon:

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 (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 mediation-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.

# Shumava Ali -S

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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K222967

Device Name

Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Compression Screws

Indications for Use (Describe)

The Avanti Orthopaedics 2.2mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## Indications for Use

510(k) Number (if known)

K222967

Device Name

Avanti Orthopaedics 3.2mm, and 4.0mm Cannulated Compression Screws

Indications for Use (Describe)

The Avanti Orthopaedics 3.2mm, and 4.0mm Cannulated Compression Screws are intended for fixatures, fusions, osteotomies, non-unions of small bones and small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------|
| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

#### 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."

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## 510(k) SUMMARY:

Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws

| Date Prepared | November 18, 2022 | | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--|
| Sponsor | Avanti Orthopaedics, Inc<br>1814 Gilpin Avenue<br>Wilmington, DE 19806<br>Phone [phone]<br>Fax [phone] | | |
| 510(k) Contact | Secure BioMed Evaluations<br>Linda Braddon, Ph.D.<br>7828 Hickory Flat Highway<br>Suite 120<br>Woodstock, GA 30188<br>770-837-2681<br>[e-mail] | | |
| Trade Name | Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws<br>Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws | | |
| Common Name | Prosthetic Device | | |
| Code –<br>Classification | Product Code: HWC<br>Regulation: 21 CFR 888.3040<br>Device Class: II | | |
| | Subject Device | Primary Predicate | |
| Primary Predicate | Avanti Orthopaedics 2.2mm and<br>2.7mm Cannulated Compression<br>Screws | K161616 DePuy Synthes 2.4 mm<br>Cannulated Screws | |
| | Avanti Orthopaedics 3.2mm and<br>4.0mm Cannulated Compression<br>Screws | K161616 DePuy Synthes 3.5 mm and<br>4.0 mm Cannulated Screws | |
| | Subject Device | Additional Predicate(s) | |
| Additional Predicate | Avanti Orthopaedics 2.2mm and<br>2.7mm Cannulated Compression<br>Screws | K180541 DePuy Synthes 2.0 mm<br>Quick Insertion Screws | |
| | Avanti Orthopaedics 3.2mm and<br>4.0mm Cannulated Compression<br>Screws | K162825 CAPTIVATE™<br>Compression Screws | |
| | Subject Device | Reference Device(s) | |
| Reference Device | Avanti Orthopaedics 2.2mm and<br>2.7mm Cannulated Compression<br>Screws | K191118 Avanti Distal Radius and<br>Forearm System | |
| | Avanti Orthopaedics 3.2mm and<br>4.0mm Cannulated Compression<br>Screws | K191118 Avanti Distal Radius and<br>Forearm System | |

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| Device Description | The Avanti Orthopaedics Cannulated Compression Screw System are metallic bone screws manufactured from Stainless Steel (ASTM F138). The screws are available in multiple lengths and diameters, and are intended to be used as stand-alone bone screws for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation. The Avanti Orthopaedics Cannulated screws are cannulated for use with guidewires for precise placement in bone. |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use Statement | Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Compression Screws:<br>The Avanti Orthopedics 2.2 mm and 2.7mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.<br><br>Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Compression Screws:<br>The Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones and small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. |

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# Comparison of Technological Characteristics: Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Compression Screws

| Characteristic | Subject Device<br>Avanti Orthopaedics 2.2mm and<br>2.7mm Cannulated Compression Screws | Primary Predicate<br>Synthes USA Products, LLC DePuy<br>Synthes 2.4 mm Cannulated Screws<br>K161616 |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Classification | Class II | Class II |
| Product Code | HWC | HWC |
| Purpose | Subject device | Same indications |
| Diameter (mm) | 2.2 – 2.7mm | 2.4mm |
| Lengths (mm) | 14 – 60mm | 10 – 50mm |
| Partially / Fully<br>Threaded | Partially Threaded<br>Fully Threaded | Partially Threaded<br>Fully Threaded |
| Head Type | Headless | Low-Profile |
| Driver Shape | Star | Star |
| Cannulated | Yes | Yes |
| Self-Tapping | Yes | Yes |
| Sterility | End-User Sterilized, Steam<br>Sterilization<br>Cycle: Pre-Vacuum<br>Temperature: 132°C (270°F)<br>Exposure Time: 4 minutes<br>Drying Time: 60 minutes | End-User Sterilized, Steam<br>Sterilization |
| Material | Stainless Steel per ASTM F138 | Stainless Steel per ASTM F138 |
| Manufacturing | Subtractive manufacturing | Subtractive manufacturing |
| Biocompatibility | Implant: Permanent Duration -<br>Implant for Tissue / Bone (>30 days)<br>Instrument: Limited Duration -<br>Implant for Tissue / Bone (< 24 hours) | Implant: Permanent Duration -<br>Implant for Tissue / Bone (>30 days)<br>Instrument: Limited Duration -<br>Implant for Tissue / Bone (< 24 hours) |
| Indicated Patient<br>Population | Adults and children (2-12 years) and<br>adolescents (12-21 years) in which<br>growth plates have fused or in which<br>growth plates will not be crossed by<br>screw fixation | Adults and children (2-12 years) and<br>adolescents (12-21 years) in which<br>growth plates have fused or in which<br>growth plates will not be crossed by<br>screw fixation |
| Characteristic | Subject Device<br>Avanti Orthopaedics 3.2mm<br>and 4.0mm Cannulated<br>Compression Screws | Primary Predicate<br>Synthes USA Products, LLC<br>DePuy Synthes 3.5 mm and<br>4.0 mm Cannulated Screws<br>K161616 |
| Device Classification | Class II | Class II |
| Product Code | HWC | HWC |
| Purpose | Subject device | Same indications |
| Diameter (mm) | 3.2 - 4.0mm | 3.5 - 4.0mm |
| Lengths (mm) | 14 - 60mm | 10 - 50mm |
| Partially / Fully Threaded | Partially Threaded<br>Fully Threaded | Partially Threaded<br>Fully Threaded |
| Head Type | Headless | Low-Profile |
| Driver Shape | Star | Hex |
| Cannulated | Yes | Yes |
| Self-Tapping | Yes | Yes |
| Sterility | End-User Sterilized, Steam<br>Sterilization<br>Cycle: Pre-Vacuum<br>Temperature: 132°C (270°F)<br>Exposure Time: 4 minutes<br>Drying Time: 60 minutes | Terminally Sterilized, Gamma<br>Irradiation |
| Material | Stainless Steel per ASTM F138 | Stainless Steel per ASTM F138 |
| Manufacturing | Subtractive manufacturing | Subtractive manufacturing |
| Biocompatibility | Implant: Permanent Duration -<br>Implant for Tissue / Bone (>30<br>days)<br>Instrument: Limited Duration -<br>Implant for Tissue / Bone (< 24<br>hours) | Implant: Permanent Duration -<br>Implant for Tissue / Bone (>30<br>days)<br>Instrument: Limited Duration -<br>Implant for Tissue / Bone (< 24<br>hours) |
| Indicated Patient Population | Adults and children (2-12 years)<br>and adolescents (12-21 years) in<br>which growth plates have fused<br>or in which growth plates will<br>not be crossed by screw<br>fixation. | Adults and children (2-12 years)<br>and adolescents (12-21 years) in<br>which growth plates have fused<br>or in which growth plates will<br>not be crossed by screw<br>fixation. |

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# Comparison of Technological Characteristics: Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Compression Screws

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## Technological Characteristics

There are no significant technological differences between the subject and predicate devices. The subject device uses the same material as the additional predicate and reference device and all devices are manufactured using subtractive techniques. Any differences in available sizes between the subject and predicate devices were addressed via the additional predicates (K180541, K162825).

## Non-Clinical Performance Testing Summary

Testing was performed per ASTM F543-17 and the device met all predetermined acceptance criteria as defined in the FDA guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers -Performance Criteria for Safety and Performance Based Pathway".

## Conclusions

Based on the similarities of the intended use/indications for use, technological and functional characteristic, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device.