(9 days)
Not Found
Not Found
No
The device description focuses solely on the mechanical design and materials of a tibial nail for fracture fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as providing alignment and stabilization for long bone fractures, specifically tibial fractures, which is a therapeutic function.
No
The device is described as a "cylindrical, cannulated stainless steel tube" used for "alignment and stabilization of long bone fractures." Its function is mechanical fixation, not diagnosis.
No
The device description clearly describes a physical, implanted medical device (a tibial nail made of stainless steel) and associated surgical instruments. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The provided description clearly states that the Osteo 9mm IC Tibial Nail is a device that is implanted into the body to fix bone fractures. It is a physical implant used in surgery.
- Intended Use: The intended use is for "long bone fracture fixation, specifically tibial fracture fixation." This is a surgical procedure performed on the body, not a diagnostic test performed on samples from the body.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Osteo 9mm IC Tibial Nail is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
- Static and compression locking
- Transverse and short oblique fractures
- Pseudarthrosis
- Correction osteotomies
The indications for the use of the Osteo 9mm IC Tibial Nail remain unchanged and are as follows: - Static and compression locking
- Transverse and short oblique fractures
- Pseudarthrosis
- Correction osteotomies
Product codes
HSB
Device Description
The Osteo 9mm IC Tibial Nail is a cylindrical, cannulated stainless steel tube. Tibial Nails provide for the alignment and stabilization of long bone fractures while maintaining limb length and resisting rotation of the fracture segments. The Osteo 9mm IC Tibial Nail is implanted in association with proximal and distal locking screws with the aid of several associated Class I manual surgical instruments. The Tibial Nails are stainless steel tubes gun-drilled from a solid Stainless Steel bar. Three external longitudinal grooves are pressed into the tube and are intended to provide greater resistance to bending and increased torsional stability. The Osteo 9mm IC Tibial Nail is available in lengths from 240mm to 420mm in 15mm increments, and has a distal shaft diameter of 9mm. A compression screw and locking screw may be used with the Tibial Nail. An end cap is also available for use with the Tibial Nail. An end cap is used if a compression screw has not been used.
The following changes have been made to the modified Tibial Nail.
- The wall thickness of the Tibial Nail has been increased by 0.2mm, resulting in a reduction 1) in the distal cannulation diameter from 6.4mm to 6.0mm. The 9mm outer diameter of the distal end of the nail remains the same.
- The length of the ø11mm proximal portion of the Tibial Nail was increased from 33mm to 2) 60mm, and the proximal portion of the nail is tapered at a 2° angle from o1 1mm to 09mm.
-
- In order to reduce irritation of the patella tendon, the proximal anterior end of the modified Tibial Nail features a small 10° chamfer 5.7mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial
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)
Osteo 9mm IC Tibial 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
SPECIAL 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Osteo 9mm IC Tibial Nail
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Contact Person:
Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 201-825-4900
Kate Sutton Regulatory Affairs Specialist
Date Summary Prepared:
Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
December 1, 1998
Osteo 9mm IC Tibial Nail
Intramedullary Nail, Tibial Nail
Intramedullary Fixation Rod 21 CFR §888.3020
Predicate Device Identification
The design and function of the Osteo 9mm IC Tibial Nail is substantially equivalent to that of the predicate Osteo 9mm IC Tibial Nail. The subject and predicate systems offer tibial nails in varying lengths, and utilize compression screws, a locking screw, and an end cap.
Device Description
The Osteo 9mm IC Tibial Nail is a cylindrical, cannulated stainless steel tube. Tibial Nails provide for the alignment and stabilization of long bone fractures while maintaining limb length and resisting rotation of the fracture segments. The Osteo 9mm IC Tibial Nail is implanted in association with proximal and distal locking screws with the aid of several associated Class I manual surgical instruments. The Tibial Nails are stainless steel tubes gun-drilled from a solid Stainless Steel bar. Three external longitudinal grooves are pressed into the tube and are intended to provide greater resistance to bending and increased torsional stability. The Osteo 9mm IC Tibial Nail is available in lengths from 240mm to 420mm in 15mm increments, and has a distal shaft diameter of 9mm. A compression screw and locking screw may be used with the Tibial Nail. An end cap is also available for use with the Tibial Nail. An end cap is used if a compression screw has not been used.
1
The following changes have been made to the modified Tibial Nail.
- The wall thickness of the Tibial Nail has been increased by 0.2mm, resulting in a reduction 1) in the distal cannulation diameter from 6.4mm to 6.0mm. The 9mm outer diameter of the distal end of the nail remains the same.
- The length of the ø11mm proximal portion of the Tibial Nail was increased from 33mm to 2) 60mm, and the proximal portion of the nail is tapered at a 2° angle from o1 1mm to 09mm.
-
- In order to reduce irritation of the patella tendon, the proximal anterior end of the modified Tibial Nail features a small 10° chamfer 5.7mm in length.
Intended Use
The Osteo 9mm IC Tibial Nail is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
- 0 Static and compression locking
-
Transverse and short oblique fractures
- Pseudarthrosis
- Correction osteotomies থা
Statement of Technological Comparison
The subject modified Osteo 9mm IC Tibial Nail components are substantially equivalent in design and intended use to the predicate unmodified Osteo 9mm IC Tibial Nail components.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle.
DEC I 6 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kate Sutton Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey
Re: K984353 Osteo 9mm IC Tibial Nail Trade Name: Regulatory Class: II Product Code: HSB December 1, 1998 Dated: December 7, 1998 Received:
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, qood manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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 regulations.
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,
Colin M. Whitton, Ph.D.
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K984353
Device Name: Osteo 9mm IC Tibial Nail
Indications For Use:
The indications for the use of the Osteo 9mm IC Tibial Nail remain unchanged and are as follows:
- . Static and compression locking
- Transverse and short oblique fractures .
- Pseudarthrosis
- Correction osteotomies ●
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K984353
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)