(113 days)
Not Found
Not Found
No
The summary describes a physical implant made of poly-L-Lactide and stainless steel for fixing bone fragments. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
No
The device is an implant used for fixation of bones and fragments, which is a structural or surgical function, not a therapeutic one.
No
The provided text describes an implant (pins) used for fixation of bony or chondral fragments and fractures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states the device is manufactured using poly(L-lactide) and stainless steel, indicating it is a physical implant, not software.
Based on the provided information, the Arthrex Bio-Pins are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as an implant used for fixing bony or chondral fragments and stabilizing fractures and fusions within the body. This is a surgical/implantable device, not a device used to examine specimens taken from the body.
- Device Description: The description mentions the materials used (poly(L-lactide) and stainless steel), which are typical for surgical implants.
- Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Reagents or kits for testing
In summary, the Arthrex Bio-Pins are a medical device intended for surgical implantation and fixation within the body, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex Bio-Pins are poly-L-Lactide based implants used to fix small bony or apical chondral fragments in the Foot, Ankle, Upper Extremities, Hand, and Wrist, where such fragments are not under tension or load-bearing. These pins are used in cases of osteochondritis dissecans and osteochondral fragments. fixation of fractures, 1st metatarsal (bunionectomy osteotomies), upper extremity fractures, cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The Bio-Pins can be used for inherently stable intramedullary stabilization of joint arthroplasty (resection) or fusion for the treatment of digital deformities of the foot or hand. The Bio-Pin is also used in inherently stable long bone fractures such as the femur, fibula, tibia, humerus, radius and ulna including the diaphyseal, epiphyseal, and metaphyseal areas.
Product codes
HTY
Device Description
The Arthrex Bio-Pins are manufactured using poly(L-lactide) and stainless steel in accordance with ASTM F138.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Foot, Ankle, Upper Extremities, Hand, Wrist, phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, femur, fibula, tibia, humerus, radius and ulna including the diaphyseal, epiphyseal, and metaphyseal areas.
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
MAY 2 7 2005
page 'f/
510(k) Summary
| 510(k) Number: | K050259 |
|---|---|
| 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 Bio-Pin |
| Common Name: | Pin |
| Classification: | Pin, Fixation, Smooth |
| Product Code: | HTY |
Description:
The Arthrex Bio-Pins are manufactured using poly(L-lactide) and stainless steel in accordance with ASTM F138.
Indications for Use:
The Arthrex Bio-Pins are poly-L-Lactide based implants used to fix small bony or apical chondral fragments in the Foot, Ankle, Upper Extremities, Hand, and Wrist, where such fragments are not under tension or load-bearing. These pins are used in cases of osteochondritis dissecans and osteochondral fragments. fixation of fractures, 1st metatarsal (bunionectomy osteotomies), upper extremity fractures, cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The Bio-Pins can be used for inherently stable intramedullary stabilization of joint arthroplasty (resection) or fusion for the treatment of digital deformities of the foot or hand. The Bio-Pin is also used in inherently stable long bone fractures such as the femur, fibula, tibia, humerus, radius and ulna including the diaphyseal, epiphyseal, and metaphyseal areas.
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 Bio-Pin and 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.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 2005
Ms. Ann Waterhouse, RAC Senior Regulatory Affairs Specialist Arthrex Incorporated 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K050259
Trade/Device Name: Arthrex Bio-Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: April 19, 2005 Received: April 20, 2005
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 clectronic 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" (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/industry/support/index.html
Sincerely yours,
Miriam Provost, Ph.D.
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K050259
Device Name: Arthrex Bio-Pin
Indications for Use:
The Arthrex Bio-Pins are poly-L-Lactide based implants used to fix small bony or apical chondral fragments in the Foot, Ankle, Upper Extremities, Hand, and Wrist, where such fragments are not under tension or load-bearing. These pins are used in cases of osteochondritis dissecans and osteochondral fragments. fixation of fractures, 1st metatarsal (bunionectorny osteotomies), upper extremity fractures, cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The Bio-Pins can be used for inherently stable intramedullary stabilization of joint arthroplasty (resection) or fusion for the treatment of digital deformities of the foot or hand. The Bio-Pin is also used in inherently stable long bone fractures such as the femur, fibula, tibia, humerus, radius and ulna including the diaphyseal, epiphyseal, and metaphyseal areas.
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Prescription Use yfer (Part 21 CFR 801 Subpart D)
AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/ORD AND/OR AND/OR AND/OR AND/OR AND/O
Over-The-Counter Use _Aro (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Styt Rhodes
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________