(31 days)
No
The 510(k) summary describes a mechanical implant for bone fixation and does not mention any software, image processing, AI, or ML capabilities.
Yes
The device is used for the "intramedullary fixation of fractures of the femur," which is a therapeutic intervention aimed at treating medical conditions.
No
The device description clearly states it is an "open reduction and internal fixation device, for the intramedullary fixation of fractures of the femur," and its intended use is for "intramedullary fixation of fractures of the femur." These functions are therapeutic, not diagnostic.
No
The device description clearly states it is a physical implantable device (nail, screws, etc.) used for fracture fixation, not a software-only product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "intramedullary fixation of fractures of the femur." This is a surgical procedure performed on the patient's body to stabilize a broken bone.
- Device Description: The description details a physical implantable device (nail, screws, etc.) used for internal fixation.
- IVD Definition: In Vitro Diagnostics are tests performed outside of the body on samples such as blood, urine, or tissue to diagnose diseases or conditions.
This device is a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The AOS ESTM Retrograde Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following: open and closed femoral fractures, pseudoarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, and tumor resections, supracondylar fractures, including those with severe comminution and intra- articular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and fractures resulting from osteoporosis.
Product codes
HSB
Device Description
The AOS Extended ShortTM (ES) Retrograde Femoral Nail is a single use, open reduction and internal fixation device, for the intramedullary fixation of fractures of the femur. The device is meant as a load sharing device, and it may be removed once the fracture has healed. The device consists of a nail, distal captured cortical and cancellous screws, proximal captured cortical screws, a locking spacer, fixation nuts and washers, and end caps.
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
The AOS ESTM Retrograde Femoral Nail System was subjected to functional testing and strength comparison analysis. The results demonstrate that the AOS ESTM Retrograde Femoral Nails and accessories are substantially equivalent to the predicates.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
July 18, 2019
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Advanced Orthopaedic Solutions, Inc. Elaine Nguyen Regulatory Affairs Specialist 3203 Kashiwa Street Torrance, California 90505
Re: K191598
Trade/Device Name: AOS ESTM Retrograde Femoral Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 31, 2019 Received: June 17, 2019
Dear Ms. Nguyen:
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 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
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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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For CAPT Raquel Peat, PhD, MPH, USPHS Director 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)
Device Name AOS ESTM Retrograde Femoral Nail
Indications for Use (Describe)
The AOS ESTM Retrograde Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following: open and closed femoral fractures, pseudoarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, and tumor resections, supracondylar fractures, including those with severe comminution and intra- articular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and fractures resulting from osteoporosis.
| 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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Special 510(k) Summary
| Date Prepared | July 3, 2019 |
|---|---|
| Submitted by | Advanced Orthopaedic Solutions, Inc. |
| 3203 Kashiwa Street | |
| Torrance, CA 90505 | |
| Phone: (310) 533-9966 | |
| Establishment Registration | 2032480 |
| Owner Operator Number | 9046896 |
| Contact Person | Elaine Nguyen, Regulatory Affairs Specialist |
| Advanced Orthopaedic Solutions, Inc. | |
| 3203 Kashiwa Street | |
| Torrance, CA 90505 | |
| (310) 533-9966 | |
| enguyen@aosortho.com | |
| Device Name | AOS ES™ Retrograde Femoral Nail |
| Common Name | Internal Fixation |
| Classification | Class II, 21 CFR 888.3020 Intramedullary Fixation Rod |
| Device Code | HSB |
| Substantially Equivalent | |
| Devices | Primary: AOS Retrograde Femoral Nail |
| (K132005, Cleared September 10, 2013) | |
| Secondary: AOS ES™ Trochanteric Nail | |
| (K103533, Cleared January 19, 2011) | |
| Device Description | The AOS Extended Short™ (ES) Retrograde Femoral Nail is a single use, |
| open reduction and internal fixation device, for the intramedullary | |
| fixation of fractures of the femur. The device is meant as a load | |
| sharing device, and it may be removed once the fracture has healed. | |
| The device consists of a nail, distal captured cortical and cancellous | |
| screws, proximal captured cortical screws, a locking spacer, fixation | |
| nuts and washers, and end caps. | |
| Indication for Use | The AOS ES™ Retrograde Femoral Nail is intended for use in |
| intramedullary fixation of fractures of the femur to include the | |
| following: | |
| Open and closed femoral fractures | |
| Pseudoarthrosis osteotomy | |
| Correction osteotomy | |
| Pathologic fractures and impending pathologic fractures | |
| Tumor resections | |
| Supracondylar fractures, including those with severe comminution and | |
| intra- articular extension | |
| Ipsilateral femur fractures | |
| Bone lengthening | |
| Fractures proximal to a total knee arthroplasty or prosthesis | |
| Fractures distal to a hip joint | |
| Non-unions and malunions | |
| Fractures resulting from osteoporosis. | |
| Substantial Equivalence | The AOS ES™ Retrograde Nail and the AOS Retrograde Nail (K132005) |
| have the same intended use, patient population, operating principle, | |
| and risk profile. They have identical manufacturing, packaging, | |
| sterilization parameters, and shipping processes, all of which will be | |
| conducted under the same quality management system. | |
| Preclinical Testing | The AOS ES™ Retrograde Femoral Nail System was subjected to |
| functional testing and strength comparison analysis. The results | |
| demonstrate that the AOS ES™ Retrograde Femoral Nails and | |
| accessories are substantially equivalent to the predicates. |
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5
Conclusion
Since the device has the same intended use and similar technological characteristics to the identified predicates, the device does not raise any different questions of safety or effectiveness. The performance testing and engineering analysis demonstrated that the subject device had substantially equivalence performance. Therefore, the premarket notification demonstrated that the device is substantially equivalent to the predicate.