(49 days)
Not Found
The provided text does not contain any K/DEN numbers. The section "Reference Device(s)" explicitly states "Not Found".
No
The description focuses solely on the physical characteristics and surgical application of a medical implant (femoral nail) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a femoral nail used for long bone fracture fixation, which is a therapeutic intervention.
No
Explanation: The device is a femoral nail used for fracture fixation, which is a therapeutic purpose, not a diagnostic one. Its description focuses on its material, shape, and surgical application.
No
The device description clearly describes a physical implant (a cylindrical, cannulated titanium alloy tube) and associated hardware (screws, end cap). It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The description clearly states that the Osteo IC Retrograde/Antegrade Femoral Nail is a surgical implant used for fixing bone fractures within the body. It is a physical device inserted into the femur.
The information provided describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Osteo IC Retrograde/Antegrade Femoral Nail is indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
- Open and closed femoral fractures.
- Pseudarthrosis and correction osteotomy.
- Pathologic fractures, impending pathologic fractures, and tumor resections.
- Supracondylar fractures, including those with intra-articular extension.
- Ipsilateral femur/tibia fractures.
- Fractures proximal to a total knee arthroplasty.
- Fractures distal to a hip implant.
- Nonunions and malunions.
Product codes
HSB
Device Description
The Osteo IC Retrograde/Antegrade Femoral Nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The Osteo IC Retrograde/Antegrade Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach. The Osteo IC Retrograde / Antegrade Femoral Nail is available in three versions, each in lengths from 240mm to 500mm in 20mm increments, and in diameters from ø9mm to ø15mm in 1mm increments. A compression screw and locking screw may be used with the Femoral Nail. An end screw and an end cap are also available for use with the Femoral Nail. An end cap or end screw is used if a compression screw has not been used. The end screw is used when the Femoral Nail has been inserted via a retrograde approach. The end cap is used when the Femoral Nail has been inserted via an antegrade approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral, Femur, Tibia, Hip
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)
Synthes Titanium Distal Femoral System, Synthes Titanium Unreamed Femoral Nail System, AIM Titanium Femoral Nail, Richards Retrograde Nail
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
SEP 1 4 1998
SUMMARY OF SAFETY AND EFFECTIVENESS Osteo IC Retrograde/Antegrade Femoral Nail
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
59 Route 17 Allendale, NJ 07401-1677 201-825-4900
Osteonics Corporation
July 22, 1998
Kate Sutton Regulatory Affairs Specialist
Date Summary Prepared:
Device Identification
Proprietary Name:
Contact Person:
Common Name:
Classification Name and Reference:
Osteo IC Retrograde/Antegrade Femoral Nail
Intramedullary Nail, Femoral Nail
Intramedullary Fixation Rod 21 CFR §888.3020
Predicate Device Identification
The design and function of the Osteo IC Retrograde/Antegrade Femoral Nail is substantially equivalent to that of the predicate Synthes Titanium Distal Femoral System, the predicate Synthes Titanium Unreamed Femoral Nail System. the predicate AIM Titanium Femoral Nail, manufactured by ACE Medical, and the predicate Richards Retrograde Nail. The subject and predicate systems offer femoral nails in varying lengths, and utilize a combination of locking screws, end caps, nuts, and washers, the combination of which varies depending on which manufacturer's product is being used.
Device Description
The Osteo IC Retrograde/Antegrade Femoral Nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The Osteo IC Retrograde/Antegrade Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach. The Osteo IC Retrograde / Antegrade Femoral Nail is available in three versions, each in lengths from 240mm to 500mm in 20mm increments, and in diameters from ø9mm to ø15mm in 1mm increments. A compression screw and locking screw may be used with the Femoral Nail. An end screw and an
1
end cap are also available for use with the Femoral Nail. An end cap or end screw is used if a compression screw has not been used. The end screw is used when the Femoral Nail has been inserted via a retrograde approach. The end cap is used when the Femoral Nail has been inserted via an antegrade approach.
Intended Use
The Osteo IC Retrograde/Antegrade Femoral Nail is indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
- Open and closed femoral fractures ●
- Pseudoarthrosis and correction osteotomy .
- . Pathologic fractures, impending pathologic fractures, and turnor resections
- . Supracondylar fractures, including those with intra-articular extension
- . Ipsilateral femur/tibia fractures
- . Fractures proximal to a total knee arthroplasty
- . Fractures distal to a hip implant
- . Nonunions and malunions
Statement of Technological Comparison
The subject Osteo IC Retrograde/Antegrade Femoral Nail components are substantially equivalent in design and intended use to the predicate devices offered by Synthes, ACE Medical, and Richards.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three human profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1998
Ms. Kate Sutton Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey
Re: K982601 Osteo IC Retrograd/Antegarde Femoral Nail Regulatory Class: II Product Code: HSB Dated: July 22, 1998 Received: July 27, 1998
Dear Ms. Sutton:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
3
Page 2 - Ms. Kate Sutton
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.
Ph.D., M.D. Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K_98 260 \
Device Name: Osteo IC Retrograde/Antegrade Femoral Nail
Indications For Use:
The Osteo IC Retrograde/Antegrade Femoral Nail is indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
- . Open and closed femoral fractures.
- . Pseudarthrosis and correction osteotomy.
- . Pathologic fractures, impending pathologic fractures, and tumor resections.
- . Supracondylar fractures, including those with intra-articular extension.
- . Ipsilateral femur/tibia fractures.
- . Fractures proximal to a total knee arthroplasty.
- . Fractures distal to a hip implant.
- . Nonunions and malunions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Decease
Division of General Restorative Device 510(k) Number.