(90 days)
Not Found
Not Found
No
The summary describes a bioabsorbable screw for bone fixation and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an implant for mechanical fixation of bone fragments, not a device that provides therapeutic treatment to a patient.
No
The device, Arthrex TRIMit implant, is described as a bioabsorbable screw intended for fixation of bone fragments. Its function is to provide physical support, not to diagnose a condition.
No
The device description clearly states it is a physical screw manufactured from poly(L-lactide), indicating it is a 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 to provide fixation of small bone fragments, specifically in metatarsal and metacarpal fractures. This is a surgical implant used directly within the body for structural support.
- Device Description: The device is described as a bioabsorbable polylactide screw. This is a physical object implanted into tissue.
- 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 samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Arthrex TRIMit implant is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of small bone fraqments such as apical fraqments. Specific indications include metatarsal and metacarpal fractures.
Product codes
HWC
Device Description
The Arthrex TRIMitTM Screw is manufactured using poly(L-lactide). It is a fully threaded small diameter screw.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
SEP 2 2 2003
510(k) Summary
| 510(k) Number: | |
|---|---|
| Company: | Arthrex, Inc. |
| Address: | 2885 S. Horseshoe Dr., Naples, FL 34104 |
| Telephone: | (239) 643-5553 |
| Facsimile: | (239) 430-3494 |
| Contact: | Ann Waterhouse |
| Trade Name: | Arthrex TRIMitTM Screw |
| Common Name: | Screw, Fixation, Bone |
| Classification: | Class II, per 888.3040 |
HWC
Description:
Product Code:
The Arthrex TRIMit™ Screw is manufactured using poly(L-lactide). It is a fully threaded small diameter screw. Further description is contained in Tab 6.
Indications for Use:
The Arthrex TRIMit implant is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of small bone fraqments such as apical fraqments. Specific indications include metatarsal and metacarpal fractures.
Predicate Devices:
Please see Tab 7 for specific information concerning predicate devices.
Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The difference between the Arthrex TRIMit Screw and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the material is well characterized and has been used in predicate devices with similar indications. The device, as designed, is as safe and effective as predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo. The logo is circular in shape and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA". In the center of the circle is a stylized image of an eagle with three lines representing its wings and body.
Public Health Service
SEP 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex, Inc. 2885 South Horseshoe Drive Naples, FL 34104
Re: K031945
Trade/Device Name: Arthrex TRIMit Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 20, 2003 Received: June 27, 2003
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.
2
Page 2 - Ms. Ann Waterhouse
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 (301) 594- _ . 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. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Mark N. Mellemson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
031945
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510(k) Number (if known):
Device Name:
Indications for Use:
The Arthrex TRIMit implant is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of small bone fragments such as apical fragments. Specific indications include metatarsal and metacarpal fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Option Format 3-10-98)
Mark H. Milken
for Division Sign Off
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031945
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