(84 days)
No
The device description focuses on the mechanical components and physical characteristics of an intramedullary nail for fracture fixation. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is an intramedullary nail system used to treat fractures of the femur, which is a therapeutic intervention.
No
This device, the AOS Trochanteric Nail, is an implantable medical device used to fix fractures of the femur. It is a treatment device, not a diagnostic one.
No
The device description clearly details physical components like an intramedullary nail, screws, and an end cap, indicating it is a hardware medical device.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The AOS Trochanteric Nail is a physical implant designed to treat bone fractures. It is surgically inserted into the femur.
- Intended Use: The intended use clearly states it's for treating fractures of the femur. This is a surgical intervention, not a diagnostic test performed on a sample.
The description focuses on the physical characteristics of the implant and its surgical application, which is consistent with a medical device used for treatment, not diagnosis.
No.
Explanation:
The provided FDA clearance letter does not contain any mention of a Predetermined Change Control Plan (PCCP). PCCP authorization is explicitly stated in the Indications for Use or a specific section detailing the pre-agreed modifications. Since this information is absent, the device is not authorized under a PCCP.
Intended Use / Indications for Use
The AOS Trochanteric Nail is intended to treat stable proximal fractures of the femur including pertrochanteric interic and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertochanteric fractures associated with shaft fractures pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, insilateral fractures, proximal and distal non-unions and malunions and revisions procedures.
Product codes
HSB
Device Description
The AOS Trochanteric Nail is femoral intramedullary nail that is design to enter through the greater trochanter. It consists of an intramedullary nail, sliding lag screw, anti-rotation screws and end cap.
The Trochanteric Nail is a cannulated nail with proximal diameter of 15mm. The short Trochanteric Nails are18cm in length and the long Trochanteric Nails are 30cm, 36cm and 42cm in length. The nails are produced in diameters of 9mm, and 11mm. The proximal end of the nail has two holes; one to accept the 11mm lag screw and one to accept the optional 5.0mm anti-rotation screw. There are two nail configurations with the proximal holes angled at 125° or 130°. The proximal holes in the long nails having 10° of anteversion and are in a left and a right configuration. The proximal end of the nail is threaded to accept an end can.
The distal end of the nail contains one cross locking hole and one cross locking slot. The distal hole and the slot are design to accept 5.0mm screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, pertrochanteric, intertrochanteric, subtrochanteric, diaphyseal
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K010780, K013563, K993670, K012158, K013524, K 912162, K921786, K954712
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
JUN 2 0 2002
510(k) SUMMARY
| NAME OF FIRM: | Advanced Orthopaedic Solutions |
|---|---|
| 510(k) CONTACT PERSON: | Paul Doner |
| Vice President Operations and Regulatory | |
| TRADE NAME: | AOS Trochanteric Nail |
| COMMON NAME: | Intramedullary Fixation Rod |
| CLASSIFICATION: | 888.3020 Intramedullary Fixation Rod. |
| DEVICE CODE: | HSB |
| SUBSTANTIALLY EQUIVALENT DEVICE: | DePuy Ace, Trochanteric Nail & Long Trochanteric Nail; |
| Howmedica, Gamma Nail & Trochanteric Dyax Nail; Smith and | |
| Nephew, Intramedullary Hip Screw |
INTENDED USE:
The AOS Trochanteric Nail is intended to treat stable proximal fractures of the femur including pertrochanteric interic and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertochanteric fractures associated with shaft fractures pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, insilateral fractures, proximal and distal non-unions and malunions and revisions procedures.
DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:
The AOS Trochanteric Nail is femoral intramedullary nail that is design to enter through the greater trochanter. It consists of an intramedullary nail, sliding lag screw, anti-rotation screws and end cap.
The Trochanteric Nail is a cannulated nail with proximal diameter of 15mm. The short Trochanteric Nails are18cm in length and the long Trochanteric Nails are 30cm, 36cm and 42cm in length. The nails are produced in diameters of 9mm, and 11mm. The proximal end of the nail has two holes; one to accept the 11mm lag screw and one to accept the optional 5.0mm anti-rotation screw. There are two nail configurations with the proximal holes angled at 125° or 130°. The proximal holes in the long nails having 10° of anteversion and are in a left and a right configuration. The proximal end of the nail is threaded to accept an end can.
The distal end of the nail contains one cross locking hole and one cross locking slot. The distal hole and the slot are design to accept 5.0mm screws.
The AOS Trochanteric Nail was shown to be substantially equivalent to the following devices.
| DePuy ACE, Trochanteric Nails | K010780 and K013563 |
|---|---|
| Howmedica Osteonics, Gamma Nails | K993670, K012158 and K013524 |
| Smith and Nephew, Intramedullary Hip Screw | K 912162, K921786 and K954712 |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2002
Mr. Paul Doner Vice President Operations and Regulatory Advanced Orthopaedic Solotions 333 W. 6th Street, Suite 202 San Pedro. CA 90731
Re: K021008
Trade/Device Name: Advanced Orthopaedic Solutions Trochanteric Nail Regulatory Number: 888.3020 Regulatory Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: March 27, 2002 Received: March 28, 2002
Dear Mr. Doner:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Paul Doner
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
for Mark N Milliken
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known)
Advanced Orthopaedic Solutions Trochanteric Nail Device Name:
KO21008
. Indications for Use:
The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, insilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109) OR
- 1 -
Over-The-Counter
Mark N Miller
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number.