(57 days)
No
The device description and intended use clearly define a mechanical bone screw system made of stainless steel, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is a metallic bone screw intended for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions, which are structural and functional repairs, not primarily therapeutic.
No
This device is described as cannulated compression screws intended for the fixation of fractures, fusions, osteotomies, and non-unions of small bones. Its function is to provide internal bone fixation, not to diagnose a condition.
No
The device description explicitly states it is a metallic bone screw system, which is a physical hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Avanti Orthopaedics Cannulated Compression Screws are metallic bone screws intended for the fixation of fractures, fusions, osteotomies, non-unions of bones. This is a surgical implant used directly within the body for structural support and healing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
HWC
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.
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
Indicated Patient Age Range
Adults and 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.
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 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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known)
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)
| ✖ 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."
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Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| 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."
4
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 | ||
| 1814 Gilpin Avenue | |||
| Wilmington, DE 19806 | |||
| Phone 302-530-6369 | |||
| Fax 302-351-4896 | |||
| 510(k) Contact | Secure BioMed Evaluations | ||
| Linda Braddon, Ph.D. | |||
| 7828 Hickory Flat Highway | |||
| Suite 120 | |||
| Woodstock, GA 30188 | |||
| 770-837-2681 | |||
| Regulatory@SecureBME.com | |||
| Trade Name | Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws | ||
| Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws | |||
| Common Name | Prosthetic Device | ||
| Code – | |||
| Classification | Product Code: HWC | ||
| Regulation: 21 CFR 888.3040 | |||
| Device Class: II | |||
| Subject Device | Primary Predicate | ||
| Primary Predicate | Avanti Orthopaedics 2.2mm and | ||
| 2.7mm Cannulated Compression | |||
| Screws | K161616 DePuy Synthes 2.4 mm | ||
| Cannulated Screws | |||
| Avanti Orthopaedics 3.2mm and | |||
| 4.0mm Cannulated Compression | |||
| Screws | K161616 DePuy Synthes 3.5 mm and | ||
| 4.0 mm Cannulated Screws | |||
| Subject Device | Additional Predicate(s) | ||
| Additional Predicate | Avanti Orthopaedics 2.2mm and | ||
| 2.7mm Cannulated Compression | |||
| Screws | K180541 DePuy Synthes 2.0 mm | ||
| Quick Insertion Screws | |||
| Avanti Orthopaedics 3.2mm and | |||
| 4.0mm Cannulated Compression | |||
| Screws | K162825 CAPTIVATE™ | ||
| Compression Screws | |||
| Subject Device | Reference Device(s) | ||
| Reference Device | Avanti Orthopaedics 2.2mm and | ||
| 2.7mm Cannulated Compression | |||
| Screws | K191118 Avanti Distal Radius and | ||
| Forearm System | |||
| Avanti Orthopaedics 3.2mm and | |||
| 4.0mm Cannulated Compression | |||
| Screws | K191118 Avanti Distal Radius and | ||
| Forearm System |
5
| 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: |
| 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. |
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Comparison of Technological Characteristics: Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Compression Screws
| Characteristic | Subject Device
Avanti Orthopaedics 2.2mm and
2.7mm Cannulated Compression Screws | Primary Predicate
Synthes USA Products, LLC DePuy
Synthes 2.4 mm Cannulated Screws
K161616 |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
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
Threaded | Partially Threaded
Fully Threaded | Partially Threaded
Fully Threaded |
| Head Type | Headless | Low-Profile |
| Driver Shape | Star | Star |
| Cannulated | Yes | Yes |
| Self-Tapping | Yes | Yes |
| Sterility | End-User Sterilized, Steam
Sterilization
Cycle: Pre-Vacuum
Temperature: 132°C (270°F)
Exposure Time: 4 minutes
Drying Time: 60 minutes | End-User Sterilized, Steam
Sterilization |
| Material | Stainless Steel per ASTM F138 | Stainless Steel per ASTM F138 |
| Manufacturing | Subtractive manufacturing | Subtractive manufacturing |
| Biocompatibility | Implant: Permanent Duration -
Implant for Tissue / Bone (>30 days)
Instrument: Limited Duration -
Implant for Tissue / Bone (30 days)
Instrument: Limited Duration -
Implant for Tissue / Bone (30
days)
Instrument: Limited Duration -
Implant for Tissue / Bone (30
days)
Instrument: Limited Duration -
Implant for Tissue / Bone (