(34 days)
Not Found
Not Found
No
The description focuses solely on the physical characteristics and intended use of a mechanical implant (proximal femoral nail) and does not mention any software, algorithms, or data processing capabilities that would indicate the presence of AI/ML.
Yes
A therapeutic device is one that treats, mitigates, or prevents a disease or condition. This device is indicated for proximal femoral fracture fixation, which is a treatment for fractures.
No
Explanation: This device is described as a "Proximal Femoral Nail" used for "proximal femoral fracture fixation". Its description details a physical implant (a cylindrical, cannulated titanium alloy tube with specific dimensions and features for insertion), not a system designed to diagnose medical conditions or diseases.
No
The device description clearly describes a physical implantable medical device made of titanium alloy, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Osteo DynaTroc™ Proximal Femoral Nail is a physical implant designed to be surgically inserted into the proximal femur to fix fractures. It is a structural device used within the body (in vivo).
- Intended Use: The intended use is for "proximal femoral fracture fixation," which is a surgical procedure, not a diagnostic test performed on a specimen.
The description clearly indicates a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Osteo DynaTroc™ Proximal Femoral Nail is indicated for proximal fracture fixation, which includes the following:
- . Intertrochanteric fractures
- . Pertrochanteric fractures
- . High subtrochanteric fractures
Product codes
HSB
Device Description
The Osteo DynaTroc™ Proximal Femoral Nail is a cylindrical, cannulated titanium alloy tube with three distal slots, which is slightly bowed (4 degrees) in the medial-lateral plane to accommodate the shape of the proximal femur. The Osteo DynaTroc™ Proximal Femoral Nail is available in three different proximal/distal nail diameters to accommodate the differing morphology of small, average, and larger size patients. The distal tip of the nail contains three slots that are intended to reduce bone stresses normally incurred during insertion of the nail and post operative healing. Two locking holes, one round and one oval-shaped, are located toward the distal end of the nail but are superior to the distal slots. The superior end of the nail contains two screw holes to accommodate lag screws. The superior lag screw hole accommodates a 6.5mm diameter lag screw, and the inferior lag screw hole accommodates a 10mm diameter lag screw. All screw holes are oriented in the medial-lateral plane. An end cap (protection screw) is screwed into the proximal end of the nail to prevent excessive tissue ingrowth. The Osteo DynaTroc™ Proximal Femoral Nail is available in lengths of 180mm, 205mm, and 220mm, and in proximal/distal diameters of 17mm/12mm, 16mm/11mm, and 15mm/10mm. The surfaces of the Osteo DynaTroc™ Proximal Femoral Nail and related components are anodized with a Type II coating process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Synthes PFN, Richards IMHS Nail, Howmedica Gamma Locking 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
OCT 2 7 1998
510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Osteo DynaTroc™ Proximal Femoral Nail
Submission Information
| Name and Address of the Sponsor of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677
201-825-4900 |
|-----------------------------------------------------------|----------------------------------------------------------------------------------|
| Contact Person: | Kate Sutton
Regulatory Affairs Specialist |
| Date Summary Prepared: | September 21, 1998 |
Device Identification
Proprietary Name: | Osteo DynaTroc™ Proximal Femoral Nail |
---|---|
Common Name: | Intramedullary Nail, Femoral Nail |
Classification Name and Reference: | Intramedullary Fixation Rod |
21 CFR §888.3020 |
Predicate Device Identification
The design and function of the Osteo DynaTroc™ Proximal Femoral Nail is substantially equivalent to that of the predicate Synthes PFN, the predicate Richards IMHS Nail, and the predicate Howmedica Gamma Locking Nail. The subject and predicate systems offer proximal femoral nails in varying lengths and diameters, and utilize a combination of locking screws, end caps, lag screws, and compression screws, the combination of which varies depending on which manufacturer's product is being used.
Device Description
The Osteo DynaTroc™ Proximal Femoral Nail is a cylindrical, cannulated titanium alloy tube with three distal slots, which is slightly bowed (4 degrees) in the medial-lateral plane to accommodate the shape of the proximal femur. The Osteo DynaTroc™ Proximal Femoral Nail is available in three different proximal/distal nail diameters to accommodate the differing morphology of small, average, and larger size patients. The distal tip of the nail contains three slots that are intended to reduce bone stresses normally incurred during insertion of the nail and post operative healing. Two locking holes, one round and one oval-shaped, are located toward the distal end of the nail but are superior to the
1
distal slots. The superior end of the nail contains two screw holes to accommodate lag screws. The superior lag screw hole accommodates a 6.5mm diameter lag screw, and the inferior lag screw hole accommodates a 10mm diameter lag screw. All screw holes are oriented in the medial-lateral plane. An end cap (protection screw) is screwed into the proximal end of the nail to prevent excessive tissue ingrowth. The Osteo DynaTroc™ Proximal Femoral Nail is available in lengths of 180mm, 205mm, and 220mm, and in proximal/distal diameters of 17mm/12mm, 16mm/11mm, and 15mm/10mm. The surfaces of the Osteo DynaTroc™ Proximal Femoral Nail and related components are anodized with a Type II coating process.
Intended Use
The Osteo DynaTroc™ Proximal Femoral Nail is indicated for proximal fracture fixation, which includes the following:
- . Intertrochanteric fractures
- . Pertrochanteric fractures
- . High subtrochanteric fractures
Statement of Technological Comparison
The subject Osteo DynaTroc™ Proximal Femoral Nail components are substantially equivalent in design and intended use to the predicate devices offered by Synthes, Richards, and Howmedica.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 1998
Ms. Elizabeth A. Staub Director, Quality Assurance and Regulatory Affairs Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
K983339 Re: Osteo DynaTroc™ Proximal Femoral Nail Trade Name: Requlatory Class: II Product Code: HSB September 21, 1998 Dated: Received: September 23, 1998
Dear Ms. Staub:
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, Druq, 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 regulation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: 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.
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Paqe 2 - Ms. Elizabeth A. Staub
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (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.qov/cdrh/dsmamain.html".
Sincerely yours,
Ph.D., M.D. Cella M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K___________________________________________________________________________________________________________________________________________________
Device Name: Osteo DynaTroc™ Proximal Femoral Nail
Indications For Use:
The Osteo DynaTroc™ Proximal Femoral Nail is indicated for proximal femoral fracture fixation, which includes the following:
- Intertrochanteric fractures .
- Pertrochanteric fractures .
- High subtrochanteric fractures .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use A
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restora 510(k) Number