(136 days)
Not Found
No
The device description and performance studies focus solely on the physical characteristics and materials of the pins and wires, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for fixation of bone fractures and bone reconstructions, which are therapeutic interventions.
No
The device is indicated for use in fixation of bone fractures, bone reconstructions, as guide pins for insertion of other implants, or for traction to the skeletal system, which are all therapeutic or procedural uses, not diagnostic.
No
The device description clearly states that the OrthoPro Steinman Pins and Kirschner Wires are physical devices constructed of stainless steel, indicating they are hardware, not 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 and intended use of the OrthoPro Steinman Pins and Kirschner Wires clearly state they are used for fixation of bone fractures, bone reconstructions, as guide pins for other implants, or for applying traction to the skeletal system. These are all procedures performed within the human body.
The device is a surgical implant used for mechanical support and manipulation of bone, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The OrthoPro Steinman Pins and Kirschner Wires are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Product codes (comma separated list FDA assigned to the subject device)
HTY pin, fixation, smooth, IDW pin, fixation, threaded
Device Description
The OrthoPro Steinman Pins and Kirschner Wires are offered in a variety of lengths, diameters, tip styles, and threading. These devices are constructed of implant grade 316LVM stainless steel conformant to ASTM F138, are provided non-sterile, and are intended for single-use only.
The OrthoPro Pins and Wires product family is available in a range of lengths, diameters, and tip styles, with and without threading.
- 3.1 Materials of Construction All pins and wires are manufactured from 316LVM surgical implant grade stainless steel certified to ASTM F138.
- 3.2 Diameter The devices will range in diameter from 0.028 inches to 0.1875 inches.
- 3.2 Length The devices range in length from 4 inches to 12 inches.
- 3.3 Distal Tip Style The devices are available in a variety of tip styles, including but not limited to trocar point, diamond point, and cove point.
- 3.4 Proximal Tip Style The devices will have proximal tip styles including but not limited to trocar point, diamond point, check point, and round.
- 3.5 Threading The devices will be provided in fully threaded, partially threaded and nonthreaded versions.
- 3.6 Device Specifications Please refer to Appendix B for detailed device specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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)
The non-clinical testing to be conducted on the OrthoPro Steinman Pins and Kirschner Wires will include material and dimensional verification.
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.
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
K07055
JUL 1 3 2007
510(k) Summary
July 12th, 2007
This safety and effectiveness summary for the OrthoPro Steinman Pins and Kirschner Wires is provided as required per section 513(i)(3) of the Food, Drug, and Cosmetic Act.
510(k) Owner:
OrthoPro LLC. 3450 S. Highland Dr. #303 Salt Lake City, UT 84106 Telephone: 801-746-0208
Authorized Contact Person: Christopher L. Cook Straits Orthopaedics Inc. 13115 NE 4th St. Suite 130 Vancouver, WA 98684 Telephone: 360-253-9761
| Trade Name: | OrthoPro Steinman Pins and Kirschner Wires |
|---|---|
| Common Name: | Steinman Pins |
| Kirschner Wires | |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Classification: | 888.3040 |
| Product Class: | II |
| Product Code: | HTY pin, fixation, smooth |
| IDW pin, fixation, threaded |
Predicate or legally marketed devices which are substantially equivalent:
| Product | 510k Number |
|---|---|
| DePuy Steinman Pins and Kirshner Wires | K960385 |
| Smith and Nephew Pins and Wires | K994143 |
| Smith and Nephew Pins and Wires | Pre-amendment |
Device Description
The OrthoPro Steinman Pins and Kirschner Wires are offered in a variety of lengths, diameters, tip styles, and threading. These devices are constructed of implant grade 316LVM stainless steel conformant to ASTM F138, are provided non-sterile, and are intended for single-use only
OrthoPro Steinman Pins and Kirschner Wires 510(k) Submission
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1
Intended Use
The OrthoPro Steinman Pins and Kirschner Wires are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Comparison of the technological characteristics of the device to predicate and legally marketed devices
The proposed devices are substantially equivalent to the identified predicate device in materials of construction, physical characteristics, and intended use.
Summary of Non-Clinical Tests
The non-clinical testing to be conducted on the OrthoPro Steinman Pins and Kirschner Wires will include material and dimensional verification.
The OrthoPro Steinman Pins and Kirschner Wires are equivalent in physical dimensions and materials to the identified predicate devices. Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices.
Contact:
CTCK
Christopher L. Cook Authorized Contact Person Vice President Regulatory Affairs Straits Orthopaedics Inc.
OrthoPro Steinman Pins and Kirschner Wires 510(k) Submission
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2
| 2.7 Classification: | 888.3040 |
|---|---|
| 2.8 Panel | Orthopedic |
| 2.9 Product Class: | II |
| Product Code | HTY pin, fixation, smooth |
| JDW pin, fixation, threaded |
2.1.1 Predicate Devices
| Product | 510k Number |
|---|---|
| DePuy Steinman Pins and Kirschner Wires | K960385 |
| Smith and Nephew Pins and Wires | K994143 |
| Smith and Nephew Pins and Wires | Pre-amendment |
3.0 Device Description
2.1.0
The OrthoPro Pins and Wires product family is available in a range of lengths, diameters, and tip styles, with and without threading.
-
3.1 Materials of Construction
All pins and wires are manufactured from 316LVM surgical implant grade stainless steel certified to ASTM F138. -
3.2 Diameter
The devices will range in diameter from 0.028 inches to 0.1875 inches. -
3.2 Length
The devices range in length from 4 inches to 12 inches. -
3.3 Distal Tip Style
The devices are available in a variety of tip styles, including but not limited to trocar point, diamond point, and cove point. -
3.4 Proximal Tip Style
The devices will have proximal tip styles including but not limited to trocar point, diamond point, check point, and round. -
3.5 Threading
The devices will be provided in fully threaded, partially threaded and nonthreaded versions. -
3.6 Device Specifications
Please refer to Appendix B for detailed device specifications.
OrthoPro Steinman Pins and Kirschner Wires 510(k) Submission
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Image /page/3/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 13 2007
OrthoPro LLC c/o Straits Orthopaedics Inc. Mr. Christopher L. Cook Vice President Regulatory Affairs 13115 NE 4th Street, Suite 130 Vancouver, WA 98684
Re: K070555
Trade/Device Name: OrthoPro Steinman Pins and Kirschner Wires Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW, HTY Dated: June 1. 2007 Received: June 11, 2007
Dear Mr. Cook:
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 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) 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 general 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Christopher L. Cook
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, nlease contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free 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 A. Milburn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
4070555 510(k) Number (If Known)
OrthoPro Steinman Pins and Kirschner Wires Device Name:
Indications for Use:
OrthoPro Steinman Pins and Kirschner Wires Indications for Use
The OrthoPro Steinman Pins and Kirschner Wires are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skelctal system.
Prescription Use X (Part 21 CFR 801 Subpart D Over the Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Mark A. Milham
(Division Sign-Off) (Division Sign of General, Restorative, Division of Neurological Devices
510(k) Number _
OrthoPro Steinman Pins and Kirschner Wires 510(k) Submission
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