(81 days)
Not Found
No
The summary describes a mechanical fixation device made of polymer and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
No.
A therapeutic device is used to treat a disease or condition. The Arthrex CrossPin™ is intended for tibial fixation of autograft or allograft ACL soft tissue grafts, which is a structural support during a surgical procedure, not a treatment in itself.
No
The device description states its purpose is for tibial fixation of soft tissue grafts, indicating it is an implantable surgical device rather than one used for diagnosis.
No
The device description explicitly states it is a sterile, disposable device constructed of an enhanced polymer, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "tibial fixation of autograft or allograft ACL soft tissue grafts." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a physical implant made of polymer, used for fixation. This is consistent with a surgical device, not a diagnostic test.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Arthrex CrossPin™ is a surgical implant used to secure tissue within the body.
N/A
Intended Use / Indications for Use
The Arthrex CrossPin™ is intended to be used for tibial fixation of autograft or allograft ACL soft tissue grafts.
Product codes
HWC, MAI, HTY
Device Description
The Arthrex CrossPin™ is a sterile, disposable device designed for single patient use only. The Cross Pin™ is constructed of an enhanced polymer, Poly(Llactide) or PLLA.
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)
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.
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Kob 2719 pge '41
510(k) Summary
MAR 06 2007
| 510(k) Number: | |
|---|---|
| Company: | Arthrex, Inc. |
| Address: | 1370 Creekside Blvd., Naples, FL 34108-1945 |
| Telephone: | (239) 643-5553 |
| Facsimile: | (239) 598-5508 |
| Contact: | Ann Waterhouse, RAC |
| Device Name: | Arthrex CrossPin ™ |
| Classification: | Screw, Fixation, Bone |
| Product Code: | HWC (21 CFR 888.3040) |
| MAI (21 CFR 888.3030) |
Description:
The Arthrex CrossPin™ is a sterile, disposable device designed for single patient use only. The Cross Pin™ is constructed of an enhanced polymer, Poly(Llactide) or PLLA.
Predicate Device;
K010633, Mitek Products RigidFix Tibial ACL Cross Pin System
Indications for Use:
The Arthrex CrossPin™ is intended to be used for tibial fixation of autograft or allograft ACL soft tissue grafts.
Substantial Equivalence Summary
The Arthrex CrossPin™ is substantially equivalent to the predicate Mitek Product RigidFix Tibial ACL Cross Pin System in which the basic features and intended uses are the same. Minor differences between the Arthrex CrossPin™ and the predicate device do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol on the right, resembling a person embracing another. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The text is written in a simple, sans-serif font.
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arthrex, Inc. % Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager 1370 Creekside Blvd. Naples, FL 34108-1945
MAR 0 6 2007
K063719 Trade/Device Name: Arthrex CrossPin™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, HWC Dated: December 14, 2006 Received: December 15, 2006
Dear Ms. Waterhouse:
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.
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Page 2 - Ms. Ann Waterhouse, RAC
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Device Name: Arthrex CrossPin™
Indications for Use:
The Arthrex CrossPin™ is intended to be used for tibial fixation of autograft or allograft ACL soft tissue grafts.
Prescription Use __ × AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (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)
Page 1 of __ 1 _
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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