(87 days)
Zimmer K-Wires, Steinmann Pins and Schanz Screws
Not Found
No
The device description and intended use focus on mechanical fixation components (pins and wires) and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The performance studies relate to material standards, not algorithmic performance.
Yes
The device is described as an internal/external fixation device for the treatment of various bone conditions, which is a therapeutic application.
No
Explanation: The device description and intended use clearly state that it is for internal/external fixation in the treatment of bone conditions, which is a therapeutic rather than a diagnostic function. There is no mention of analysis, detection, or diagnosis in the provided text.
No
The device description explicitly states it consists of physical components (fixation pins and wires made of stainless steel) and is intended for internal/external fixation, which is a hardware-based procedure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are for "unilateral internal/external fixation in the treatment of bone conditions". This involves direct interaction with the patient's body for structural support and treatment of bone issues.
- Device Description: The description details physical components like "fixation pins and wires" made of stainless steel, designed to be implanted or used externally to stabilize bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve analyzing biological samples.
Therefore, the KMedic® Internal/External Fixation Devices are medical devices used for surgical intervention and fixation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The KMedic® Internal/External Fixation Devices are non-sterile, single-use; internal/external fixation devices intended to be used for unilateral internal/external fixation in the treatment of bone conditions including limb lengthening, osteotomies; arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the internal/external fixation modality.
Product codes
HTY, JDW, and HWC
Device Description
The KMedic® Internal/External Fixation Devices consist of various fixation pins and wires for use in unilateral internal/external fixation. The various lengths, sizes and end configurations are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference. All KMedic® Internal/External Fixation Devices included in this submission are manufactured from stainless steel and will be offered non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone conditions
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
The KMedic® Internal/External Fixation Devices comply with ASTM F138-03 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" and ASTM F366-04 "Standard Specification for Fixation Pins and Wires".
Key Metrics
Not Found
Predicate Device(s)
Zimmer K-Wires, Steinmann Pins and Schanz Screws (Pre-Amendment)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K010561
Teleflex Medical KMedic@ Internal/External Fixation Devices Abbreviated PreMarket Notification (510(k)) Submission
MAY 2 5 2007
SECTION 5 - 510(K) SUMMARY
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS KMedic® Internal/External Fixation Devices
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical 2345 Waukegan Road Bannockburn, IL 60015 USA Phone: 847-572-8002 Fax: 847-572-8001
B. Contact Person
Lori Hays Director, Regulatory Affairs
C. Date Prepared
February 22, 2007
D. Device Name
Trade Name: KMedic® Internal/External Fixation Devices
Common Name: Internal/External Fixation Devices
Classification Name: Smooth or threaded metallic bone fixation fastener
.
Product Code: HTY, JDW, and HWC
Regulation Number: 21 CFR § 888.3040
Class: II
E. Device Description
The KMedic® Internal/External Fixation Devices consist of various fixation pins and wires for use in unilateral internal/external fixation. The various lengths, sizes and end configurations are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference. All KMedic® Internal/External Fixation Devices included in this submission are manufactured from stainless steel and will be offered non-sterile.
1
Teleflex Medical KMedic® Internal/External Fixation Devices Abbreviated PreMarket Notification (510(k)) Submission
F. Indications for Use
The KMedic® Internal/External Fixation Devices are non-sterile, single-use; internal/external fixation devices intended to be used for unilateral internal/external fixation in the treatment of bone conditions including limb lengthening, osteotomies; arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the internal/external fixation modality.
G. Substantial Equivalence
The device is similar in intended use, materials, design, and performance characteristics to the Zimmer K-Wires, Steinmann Pins and Schanz Screws (Pre-Amendment). The determination of substantial equivalence for this device was based on a detailed device description and conformance with voluntary standards.
H. Summary of Testing
The KMedic® Internal/External Fixation Devices comply with ASTM F138-03 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" and ASTM F366-04 "Standard Specification for Fixation Pins and Wires".
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned in the center of a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the border.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Teleflex Medical c/o Ms. Daphne D. Maurer Vice President, Regulatory Affairs 2345 Waukegan Road Suite 120 Bannockburn, Illinois 60015
MAY 2 5 2007
Re: K070561
Trade/Device Name: KMedic® Internal/External Fixation Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: HTY, JDW, and HWC Dated: May 3, 2007 Received: May 4, 2007
Dear Ms. Maurer:
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 commercc 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 gencral 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Ms. Daphnc D. Maurer
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial cquivalence 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, Intcrnational and Consumer Assistance at its toll-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Teleflex Medical KMedic® Internal/External Fixation Devices Abbreviated PreMarket Notification (510(k)) Submission
SECTION 4 - INDICATIONS FOR USE STATEMENT
510(k) Number (if known): KO7056 Device Name: __ KMedic® Internal/External Fixation Devices
Indications for Use:
The KMedic® Internal/External Fixation Devices are non-sterile, single-use; internal/external fixation devices intended to be used for unilateral internal/external fixation in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the internal/external fixation modality.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
।
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millenson
(Division Sign-Off) Division of General, Restorative, and Neurological De
510(k) Number
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