(88 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of a titanium screw, with no mention of AI or ML technologies.
Yes
The device is used for the "fixation of ligaments and tendons in patients requiring ligament or tendon repair," indicating a therapeutic purpose.
No
Explanation: The device is a surgical implant (interference screw) used for fixation of ligaments and tendons, not for diagnosing conditions.
No
The device description explicitly states it is a "cannulated, tapered fastener" made from a Titanium alloy, which is a physical hardware component, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Parcus Titanium Interference Screw is a physical implant used to fix ligaments and tendons within the body during surgical repair. It does not analyze biological samples.
The information provided clearly describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Product codes
HWC, MBI
Device Description
The Parcus Titanium Interference Screw is a cannulated, tapered fastener for use in interference fixation of ligaments and tendons in patients requiring ligament or tendon repair. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 pull out strength and insertion torque was measured for the smallest (7mm) and largest (12mm) Parcus Titanium Interference Screws as well as an intermediate size. Side by side comparisons were done with the predicate devices and results of the insertion torque testing and pullout force demonstrated that there were no significant differences between the Parcus Titanium Interference Screw and the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for PARCUS Medical, LLC. Above the logo is the text "K083619 (pg. 1 of 2)". The logo is black and white and features the company name in a bold, sans-serif font.
SURGICAL INNOVATION >> VALUE DRIVEN
510(k) Summary
| Submitter: | Parcus Medical, LLC
839 South Neenah Ave.
Sturgeon Bay, WI 54234 | MAR 6 2009 |
|----------------------|-----------------------------------------------------------------------------------------------|------------|
| Company Contact: | Barton Bracy
Phone: (920) 746-2972
Fax: (920) 746-8665 | |
| Date Prepared: | December 1, 2008 | |
| Trade Name: | Parcus Titanium Interference Screw | |
| Common Name: | Interference Screw | |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue
21 CFR 888.3040 - Product Code HWC and MBI | |
Predicate Devices:
- Arthrex Interference Screw (K062466) �
- Smith & Nephew BioRCI Screw (K032224)
- Smith & Nephew Titanium Interference Screws (K040331)
Device Description:
The Parcus Titanium Interference Screw is a cannulated, tapered fastener for use in interference fixation of ligaments and tendons in patients requiring ligament or tendon repair. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length.
Intended Use:
The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Substantial Equivalence Summary:
The Parcus Titanium Interference Screw is substantially equivalent to the predicate devices listed above in which the basic features and intended uses are the same. Any differences between the Titanium Interference Screw and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness.
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839 S NEENAH AVE., STURGEON BAY, WI 54235
1-877-746-2972
1
K083619 (pg. 2 of 2)
PARCUS Medical, LLC
SURGICAL INNOVATION >> VALUE DRIVEN
Summary Performance Data:
The pull out strength and insertion torque was measured for the smallest (7mm) and largest (12mm) Parcus Titanium Interference Screws as well as an intermediate size. Side by side comparisons were done with the predicate devices and results of the insertion torque testing and pullout force demonstrated that there were no significant differences between the Parcus Titanium Interference Screw and the predicate devices.
Page 16 of 97
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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Parcus Medical, LLC % Mr. Barton Bracy 839 South Neenah Avenue Sturgeon Bay, Wisconsin 54234
6 2009 MAR
Re: K083619
Trade/Device Name: Parcus Titanium Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MBI Dated: December 1, 2008 Received: December 8, 2008
Dear Mr. Bracy:
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Barton Bracy
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, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ KO8 3619
Device Name: _Parcus Titanium Interference Screw
Indications for Use:
The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oil) Division of General, Restorative, and Neurological Device
510(k) Number
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