(182 days)
Not Found
Not Found
No
The device description and intended use focus solely on the physical characteristics and surgical applications of a polylactide screw, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The document describes the device as implants for maintaining alignment and fixation of fractures, osteotomies, arthrodeses, or condylar grafts, which are structural and functional repairs rather than therapeutic treatments.
No
The prompt states the device "are implants for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts." This describes a therapeutic, not diagnostic, function.
No
The device description clearly states that the device is a family of threaded, fully cannulated implants made of polylactide (PLLA), which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implant for the maintenance of alignment and fixation of fractures, osteotomies, arthrodeses, or condylar grafts in various anatomical locations. This is a surgical implant used directly in the body for structural support and repair.
- Device Description: The device is described as threaded, fully cannulated implants made of polylactide (PLLA). This further confirms its nature as a physical implant.
- 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 screening.
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™ Family, made of polylactide (PLLA), are implants for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts of the foot, ankle, hand, wrist, elbow, and shoulder in the presence of appropriate brace and/or immobilization. More specific surgeries are included in the statement of intended use.
More specific surgeries include:
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valqus Reconstruction (proximal and chevron), Midfoot Reconstruction, Metacarpal and Metatarsal fusions and Ligament Repair, Tendon transfer in the foot/ankle such as Posterior Tibial Tendon Transfer for Posterior Tibial Tendon Dysfunction, Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Dysfunction, Kidner transfer, Extensor Hallucis Longus transfer, Flexor Hallucis Longus for Achilles Tendon reconstruction, Weber A and B fractures, Lateral and Medical Malleolus Ankle Fracture, Osteochondritis Dissecans, Fractures of the Distal Radius, tibial tubercle avulsions in adolescence
- Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, phalangeal fracture and fusion, metacarpal fracture and fusion, carpal fusion and fracture, wrist arthrodesis, distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device Description
The Arthrex TRIMit™ Family of screws are manufactured using poly(L-lactide). They are threaded, fully cannulated implants. The TRIMit™ implants are available with a reusable driver for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone using a drill of the appropriate size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, hand, wrist, elbow, and shoulder
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): 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.
Not Found
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
510(k) Summary
| 510(k) Number: | |
|---|---|
| Company: | Arthrex, Inc. |
| Address: | 1370 Creekside Blvd., Naples, FL 34108-1945 |
| Telephone: | (239) 643-5553 |
| Facsimile: | (239) 598-5539 |
| Contact: | Ann Waterhouse |
| Trade Name: | Arthrex TRIMit™ Family |
| Common Name: | Bone Fixation Fastener |
| Classification: | Fastener, Fixation, Biodegradable, Soft Tissue |
| Product Code: | MAI, HWC |
Description:
NOV - 4 2004
The Arthrex TRIMit™ Family of screws are manufactured using poly(L-lactide). They are threaded, fully cannulated implants. The TRIMit™ implants are available with a reusable driver for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone using a drill of the appropriate size.
Indications for Use:
The Arthrex TRIMit™ Family, made of polylactide (PLLA), are implants for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts of the foot, ankle, hand, wrist, elbow, and shoulder in the presence of appropriate brace and/or immobilization. More specific surgeries are included in the statement of intended use.
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™ Family of screws and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The devices. as designed, are as safe and effective as predicate devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 2004
Ms. Ann Waterhouse, RAC Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K041189
Trade/Device Name: Arthrex TRIMit™ Family Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI Dated: August 5, 2004 Received: August 9, 2004
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, 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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
L. Mark A. Millman
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
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Page 1 of 1
510(k) Number (if known):
Device Name: Arthrex TRIMit™ Family
Indications for Use:
The Arthrex TRIMit™ Family, made of polylactide (PLLA), are implants for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or mantenants of the foot, ankle, hand, wrist, elbow, and shoulder in the ochaylae of appropriate brace and/or immobilization. More specific surgeries include:
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valqus Reconstruction (proximal and chevron), Midfoot Reconstruction, Metacarpal and Metatarsal fusions and Ligament Repair, Tendon transfer in the foot/ankle such as Posterior Tibial Tendon Transfer for Posterior Tibial Tendon Dysfunction, Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Dysfunction, Kidner transfer, Extensor Hallucis Longus transfer, Flexor Hallucis Longus for Achilles Tendon reconstruction, Weber A and B fractures, Lateral and Medial Malleolus Ankle Fracture, Osteochondritis Dissecans, Fractures of the Distal Radius, tibial tubercle avulsions in adolescence
- Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, phalangeal fracture and fusion, metacarpal fracture and fusion, carpal fusion and fracture, wrist arthrodesis, distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
for Marl A. Milun
(Division Sign-off)
Division of General, Restorative,
and Neurological Devices