(26 days)
No
The device description and performance studies focus on the mechanical properties and MR compatibility of a metallic bone screw, with no mention of AI or ML.
Yes
The device is described as a "trochanteric nail" and an "anti-rotation screw" intended to treat various fractures of the femur. These are implantable devices designed to mechanically stabilize bone fractures, which is a therapeutic intervention.
No
The device description clearly states it is a trochanteric nail and anti-rotation screw, which are used to treat fractures. This is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a physical screw made of Titanium Alloy, intended for surgical implantation.
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 to treat bone fractures within the body (in vivo). IVDs are used to examine specimens taken from the body (in vitro) to provide information about a person's health.
- Device Description: The device is a screw made of titanium alloy, designed to be implanted in bone. This is consistent with a surgical implant, not an IVD.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
- Performance Studies: The performance studies focus on mechanical properties (torque, strength) and MR compatibility, which are relevant to implanted medical devices, not IVDs.
Therefore, this device is a surgical implant used for treating bone fractures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, peritrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and revisions procedures.
The ES trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.
Product codes
HSB
Device Description
The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is 5.0 mm in diameter and 15 mm in length. The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is a line extension to the Anti-Rotation Screws cleared within Arthrex Intramedullary Nails (K230257). The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is manufactured from Titanium Alloy conforming to ASTM F136. The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is sold sterile and is single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur
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)
Arthrex conducted failure torque/insertion torque, and torsional yield strength testing in accordance with ASTM F543 (Specification and Test Methods for Metallic Bone Screws) was performed on the Arthrex Anti-Rotation Screw, 5.0 x 115 mm to address the potential risk of decreased mechanical strength.
The Arthrex Anti-Rotation Screw, 5.0 x 115 mm was evaluated to ensure that the additional length would not represent a new worst-case in terms of MR compatibility and to justify that the previously determined MR Conditional labeling cleared within the primary predicate device Arthrex Intramedullary Nails (K230257) is appropriate.
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
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January 13, 2025
Image /page/0/Picture/1 description: The image shows the logo for 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Arthrex Inc. Stacy Valdez Principal Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K243890
Trade/Device Name: Arthrex Intramedullary Nails Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: December 17, 2024 Received: December 18, 2024
Dear Stacy Valdez:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Farzana Sharmin -S Sharmin -S Sharmin -S
Farzana Sharmin -S Sharmin -S Sharmin -S
-S - Date: 2025.01.13 16:54:32 -05'00'
Farzana Sharmin, PhD Assistant Director DHT6A: Division of Joint Arthroplasty 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
Submission Number (if known)
Device Name
Arthrex Intramedullary Nails
Indications for Use (Describe)
The trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, peritrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and revisions procedures.
The ES trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.
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
| Date Prepared | 01/13/2025 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Name: Stacy Valdez |
| Title: Principal Regulatory Affairs Specialist | |
| Phone: 1-239-643-5553 ext. 72010 | |
| Email: stacy.valdez@arthrex.com | |
| Trade Name | Arthrex Intramedullary Nails |
| Common Name | Rod, Fixation, Intramedullary and Accessories |
| Product Code | HSB |
| Classification Name | 21 CFR 888.3020: Intramedullary Fixation Rod |
| Regulatory Class | II |
| Predicate Device | K230257: Arthrex Intramedullary Nails |
| Reference Device | K132217: Arthrex Compression FT Screws |
| K233134: I.T.S. INS Proximal Femur Nail | |
| Purpose of Submission | This Special 510(k) premarket notification is |
| submitted to obtain clearance of the Anti-Rotation | |
| Screw, 5.0 x 115 mm as a line extension to the Arthrex | |
| Intramedullary Nails cleared within K230257. | |
| Device Description | The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is 5.0 |
| mm in diameter and 15 mm in length. The Arthrex | |
| Anti-Rotation Screw, 5.0 x 115 mm is a line extension | |
| to the Anti-Rotation Screws cleared within Arthrex | |
| Intramedullary Nails (K230257). The Arthrex Anti- | |
| Rotation Screw, 5.0 x 115 mm is manufactured from | |
| Titanium Alloy conforming to ASTM F136. The Arthrex | |
| Anti-Rotation Screw, 5.0 x 115 mm is sold sterile and | |
| is single-use. | |
| Indications for Use | The trochanteric nail is intended to treat stable and |
| unstable proximal fractures of the femur including | |
| peritrochanteric, intertrochanteric and high | |
| subtrochanteric fractures and combinations of these | |
| fractures. The long trochanteric nail is additionally | |
| indicated for subtrochanteric fractures, | |
| peritrochanteric fractures associated with shaft | |
| fractures, pathologic fractures (including prophylactic | |
| use) in osteoporotic bone of the trochanteric and | |
| diaphyseal areas, long subtrochanteric fracture, | |
| ipsilateral femoral fractures, proximal and distal non- | |
| unions and malunions and revisions procedures. | |
| The ES trochanteric nail is intended to treat stable and | |
| unstable proximal fractures of the femur including | |
| peritrochanteric, intertrochanteric and high | |
| subtrochanteric fractures and combinations of these | |
| fractures. | |
| Performance Data | Arthrex conducted failure torque/insertion torque, |
| and torsional yield strength testing in accordance with | |
| ASTM F543 (Specification and Test Methods for | |
| Metallic Bone Screws) was performed on the Arthrex | |
| Anti-Rotation Screw, 5.0 x 115 mm to address the | |
| potential risk of decreased mechanical strength. | |
| The Arthrex Anti-Rotation Screw, 5.0 x 115 mm was | |
| evaluated to ensure that the additional length would | |
| not represent a new worst-case in terms of MR | |
| compatibility and to justify that the previously | |
| determined MR Conditional labeling cleared within | |
| the primary predicate device Arthrex Intramedullary | |
| Nails (K230257) is appropriate. | |
| Technological Comparison | Compared to the predicate device Arthrex |
| Intramedullary Nails (K230257), the Arthrex Anti- | |
| Rotation Screw, 5.0 x 115 mm is identical in design, | |
| diameter, fundamental scientific technology, | |
| materials, packaging, sterility, shelf-life, and MRI | |
| labeling. The only difference is related to the length. | |
| The Arthrex Anti-Rotation Screw, 5.0 x 115 mm will | |
| introduce a longer length (115 mm) than the | |
| predicate device Arthrex Intramedullary Nails | |
| (K230257). | |
| Conclusion | The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is |
| substantially equivalent to the predicate devices | |
| cleared under K230257 in which basic design features | |
| and intended use are the same. Any differences | |
| between the Arthrex Anti-Rotation Screw, 5.0 x 115 | |
| mm and the predicate device is considered minor and | |
| do not raise different questions of safety or | |
| effectiveness. Based on the indications for use, | |
| technological characteristics, and the summary of | |
| data submitted, Arthrex Inc. has determined that the | |
| proposed device is substantially equivalent to the | |
| currently marketed predicate devices. |
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