(165 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the implant, with no mention of AI or ML technologies.
Yes
The device is used to aid in the alignment and stabilization of humeral fractures, serving as a therapeutic aid in the treatment of a medical condition.
No
The device description indicates that the Atlas™ Humeral Nail System is used to "aid in the alignment and stabilization of humeral fractures," which is a treatment function, not a diagnostic one.
No
The device description clearly outlines a system of physical implants (humeral nail, screws, end caps) made of titanium alloy, intended for surgical implantation. There is no mention of software as a component of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in the alignment and stabilization of humeral fractures." This is a therapeutic and structural function within the body.
- Device Description: The device is a system of implants (nail, screws, talons, end caps) made of titanium alloy, designed to be surgically implanted to fix bone fractures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and stabilization.
N/A
Intended Use / Indications for Use
The Atlas™ Humeral Nail System is indicated to aid in the alignment and stabilization of humeral fractures, including:
- · Diaphyseal fractures of the humeral shaft
- · Proximal humeral fractures with diaphyseal extension
- · Impending pathologic fractures
Product codes
HSB
Device Description
The Atlas™ Humeral Nail System is used to aid in the alignment and stabilization of humeral fractures. The system consists of the following parts:
. A humeral nail with proximal portals for passage of cortical locking screws and/or Atlas™ Screws. The humeral nail also has distal portals that allow passage of deployable integral talons from within the intramedulary canal. The distal talons may be retracted for removal of the nail is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons and distal end cap already installed.
· Cortical locking screws will be provided separately. The cortical locking screws have a reduced minor diameter at the tip which provides increased purchase in cancellous bone by increasing the thread height and are provided for proximal fixation if desired. · Atlas™ Screws will be provided separately. The Atlas™ Screws have distal portals that allow the passage of integral talons that can be deployed for additional fixation and stability.
· A proximal end cap will be provided separately. The end cap prevents bony ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail. The proximal end cap also comes in a locking version which includes a distal shaft that locks the cortical locking screw or Atlas™ screw placed in the most proximal portal.
ODI-NA will manufacture the implant grade titanium alloy (Ti-6AL-4V-ELI) per ASTM F136. The implants will be offered in both sterile (steam) and non-sterile packaging configurations and are intended for single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humeral fractures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 following nonclinical performance tests were performed to demonstrate substantial equivalence to the predicate:
- · Engineering analysis of humeral nails considering:
- o Four-point bending strength
- o Torsional strength
- · Bending fatigue test of Atlas™ Screws per ASTM F1264-16
- · Bending fatigue test of Locking Screws per ASTM F1264-16
- · Testing of Atlas™ Screws per ASTM F543
- · Testing of Locking Screws per ASTM F543
- · Cyclic loading of implanted Talons
- · Cyclic loading of implanted Atlas™ Screws with Talons deployed
The totality of data collected through performance testing and analysis has successfully demonstrated the Atlas " Humeral Nail System is substantially equivalent to the previously cleared predicate device currently marketed for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 888.3020 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.
0
November 5, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Orthopedic Designs North America, Inc. (ODI-NA) Robin Wilson Quality Manager 5912 Breckenridge Parkway, Suite F Tampa, Florida 33610
Re: K241484
Trade/Device Name: Atlas™ Humeral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: Mav 24, 2024 Received: October 8, 2024
Dear Robin Wilson:
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"
1
(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).
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Atlas ™ Humeral Nail System
Indications for Use (Describe)
The Atlas™ Humeral Nail System is indicated to aid in the alignment and stabilization of humeral fractures, including:
- · Diaphyseal fractures of the humeral shaft
- · Proximal humeral fractures with diaphyseal extension
- · Impending pathologic 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)
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
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4
K241484 Page 1 of 2
| 510(k) #: | K241484 |
|---|---|
| ----------- | --------- |
| 510(k) Summary | |
|---|---|
| Prepared on: 2024-11-05 |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| ----------------- | --------------------- |
| Applicant Name | Orthopedic Designs North America, Inc. (ODI-NA) |
|---|---|
| Applicant Address | 5912 Breckenridge Parkway, Suite F Tampa FL 33610 United States |
| Applicant Contact Telephone | 8134434905 |
| Applicant Contact | Ms. Robin Wilson |
| Applicant Contact Email | rwilson@odi-na.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| ------------- | --------------------- |
| Device Trade Name | Atlas ™ Humeral Nail System |
|---|---|
| Common Name | Rod, Fixation, Intramedullary And Accessories |
| Classification Name | Intramedullary fixation rod |
| Regulation Number | 888.3020 |
| Product Code(s) | HSB |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K173255 | Talon ™ DistalFix™ Humeral Nail | HSB |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
The Atlas™ Humeral Nail System is used to aid in the alignment and stabilization of humeral fractures. The system consists of the following parts:
. A humeral nail with proximal portals for passage of cortical locking screws and/or Atlas™ Screws. The humeral nail also has distal portals that allow passage of deployable integral talons from within the intramedulary canal. The distal talons may be retracted for removal of the nail is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons and distal end cap already installed.
· Cortical locking screws will be provided separately. The cortical locking screws have a reduced minor diameter at the tip which provides increased purchase in cancellous bone by increasing the thread height and are provided for proximal fixation if desired. · Atlas™ Screws will be provided separately. The Atlas™ Screws have distal portals that allow the passage of integral talons that can be deployed for additional fixation and stability.
· A proximal end cap will be provided separately. The end cap prevents bony ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail. The proximal end cap also comes in a locking version which includes a distal shaft that locks the cortical locking screw or Atlas™ screw placed in the most proximal portal.
ODI-NA will manufacture the implant grade titanium alloy (Ti-6AL-4V-ELI) per ASTM F136. The implants will be offered in both sterile (steam) and non-sterile packaging configurations and are intended for single-use.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Atlas™ Humeral Nail System is indicated to aid in the alignment and stabilization of humeral fractures, including:
· Diaphyseal fractures of the humeral shaft
· Proximal humeral fractures with diaphyseal extension
· Impending pathologic fractures
5
K241484 Page 2 of 2
Indications for Use Comparison
The indications for use are the same between the subject device and the predicate device.
Technological Comparison
The Atlas™ Humeral Nail System is substantially equivalent to the predicate device in which the intended use, materials, sterlity, principle of operation and indications for use are identical. There are minor differences in technological characteristics between the subject device and predicate device regarding:
- · Proximal diameter
- · Number and orientation of proximal screw portals
- · Screw size
- · Addition of Atlas™ screw
These minor differences do not raise different questions of safety or effectiveness and substantial equivalence is demonstrated through the testing described below.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following nonclinical performance tests were performed to demonstrate substantial equivalence to the predicate:
- · Engineering analysis of humeral nails considering:
- o Four-point bending strength
- o Torsional strength
- · Bending fatigue test of Atlas™ Screws per ASTM F1264-16
- · Bending fatigue test of Locking Screws per ASTM F1264-16
- · Testing of Atlas™ Screws per ASTM F543
- · Testing of Locking Screws per ASTM F543
- · Cyclic loading of implanted Talons
- · Cyclic loading of implanted Atlas™ Screws with Talons deployed
The totality of data collected through performance testing and analysis has successfully demonstrated the Atlas " Humeral Nail System is substantially equivalent to the previously cleared predicate device currently marketed for the same intended use.