(75 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is used for skeletal traction and fracture fixation, which are therapeutic interventions aimed at treating medical conditions.
No
Kirschner Wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, and as fracture fixation devices. They are used for treatment and support, not for diagnosis.
No
The device description clearly states it is a physical medical device (Kirschner Wires) made of stainless steel, available in different diameters and lengths, with threaded and smooth components and a trocar point. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the Kirschner Wires clearly indicate they are surgical implants used within the body for skeletal traction and fracture fixation. They are not used to analyze samples taken from the body.
The information provided focuses on the mechanical function and surgical application of the wires, not on any diagnostic testing performed on biological samples.
N/A
Intended Use / Indications for Use
Kirschner Wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, and as guide wires in hip pinning, and as fracture fixation devices in certain other small-bone fractures.
Indications:
- For use as guide wires in hip pinning procedures, .
- For use in aligning and reducing long bone fractures, .
- For use in securing non-long bone fractures such as olecranon fractures; patella . fractures; tibial plateau fractures; small hand and foot bone fractures; humeral, radial and ulnar fractures; etc.
- . For use with cerclage wire/cable in treating greater trochanter fractures.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The subject Kirschner Wires include both threaded and smooth components, and are available in a range of diameters and lengths. Both the threaded and smooth designs feature a trocar point. This submission includes both sterile and non-sterile product offerings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bone fractures, hip, olecranon, patella, tibial plateau, small hand and foot bones, humeral, radial, ulnar, greater trochanter
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)
As the subject Osteo Kirschner Wires are stainless steel wires with diameters not smaller than those featured in the predicate device systems, testing is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Kirschner Wires.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Osteonics® Acetabular Wedge System
510(k) Summary
510(k) SUMMARY Osteo Kirschner Wires
AUG 1 1 1997
Submission Information
| Name and Address of the Sponsor: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
|---------------------------------------|------------------------------------------------------------------|
| Name and Address of the Manufacturer: | Osteo AG |
Name and Address of the Manufacturer: Osteo AG Bohnackerweg 1 CH-2545 Selzach, Switzerland
Contact Person:
Date of Summary Preparation:
May 27, 1997
Allendale NJ 07401
Terry Sheridan
59 Route 17
Regulatory Affairs Specialist
Osteonics Corporation
Device Identification
| Proprietary Name: | Osteo Kirschner Wires |
|---|---|
| Common Name: | Kirschner wires (K wires) |
| Classification Name and Reference: | Smooth or Threaded Metallic Bone |
| Fixation Fasteners | |
| 21 CFR §888.3040 |
1
Predicate Device Identification
The Osteo Kirschner Wires are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:
- . Osteo Kirschner Wires (Osteo AG)
- . Kirschner Wires (Smith + Nephew Richards)
- . Kirschner Wires (Synthes)
Device Description
The subject Kirschner Wires include both threaded and smooth components, and are available in a range of diameters and lengths. Both the threaded and smooth designs feature a trocar point. This submission includes both sterile and non-sterile product offerings.
Intended Use
Kirschner Wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, and as guide wires in hip pinning, and as fracture fixation devices in certain other small-bone fractures.
Indications and Contraindications
Indications
- For use as guide wires in hip pinning procedures, .
- For use in aligning and reducing long bone fractures, .
- For use in securing non-long bone fractures such as olecranon fractures; patella . fractures; tibial plateau fractures; small hand and foot bone fractures; humeral, radial and ulnar fractures; etc.
- . For use with cerclage wire/cable in treating greater trochanter fractures.
Statement of Technological Comparison:
The subject and predicate devices share the same intended uses. The subject and predicate devices are both manufactured from implantable stainless steel that complies with ASTM F-138-92. The subject Osteo Kirschner Wires come in threaded and smooth designs, as do the predicate devices cited. The subject devices come in diameters and lengths consistent with the range available for the predicate devices.
2
Performance Data:
. . .
ﻣﻤﺎﺛﻠﺔ ﻣ
As the subject Osteo Kirschner Wires are stainless steel wires with diameters not smaller than those featured in the predicate device systems, testing is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Kirschner Wires.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Terry Sheridan Regulatory Affairs Specialist Osteonics Corporation ....... 59 Route 17 Allendale, New Jersey 07401-1677
AUG 11 1997
Re : K971962 Osteo Kirschner Wires Requlatory Class: II Product Code: HTY Dated: May 27, 1997 Received: May 28, 1997
Dear Ms. Sheridan:
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 Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 regulation 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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Page 2 - Ms. Terry Sheridan
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.D. 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 Kirschner Wires
Indications For Use:
Kirschner Wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, and as guide wires in hip pinning, and as fracture fixation devices in certain other smallbone fractures.
Indications
- For use as guide wires in hip pinning procedures, .
- . For use in aligning and reducing long bone fractures,
- For use in securing non-long bone fractures such as olecranon fractures; patella fractures; . tibial plateau fractures; small hand and foot bone fractures; humeral, radial and ulnar fractures; etc.
- For use with cerclage wire/cable in treating greater trochanter fractures. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(પ્ર
Over-The-Counter Uset Use ____________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Acotella
on Sion-Off Division of General Restorative Device 510(k) Number