(85 days)
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Not Found
No
The summary describes a physical implant (screw) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device description indicates it is an implant (screw) used for fixation of fractures, osteotomies, and arthrodesis, which is a physical repair of tissue and not a therapeutic treatment.
No
The Arthrex Bio-Compression Screw is a device intended for fixation of fractures, osteotomies, and arthrodesis, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it is comprised of "implants in various lengths and diameters," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the Arthrex Bio-Compression Screw is an implant made of PLLA intended for the fixation of fractures, osteotomies, and arthrodesis in various bones. This is a surgical implant used within the body for structural support and healing.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or providing diagnostic information based on such tests.
Therefore, based on the provided information, the Arthrex Bio-Compression Screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex Bio-Compression Screw is intended for fixation of fractures, osteotomies and arthrodesis in:
- Carpal, metacarpal, and small hand bone
- tarsal and metatarsals
- phalanges
- Intra-articular fractures
- ankle
- proximal and distal humerus
- proximal and distal radius
- proximal and distal ulna
- osteochondral fixation and fractures
- Osteochondritis Dissecans
- Fixation of fractures and osteotomies about the knee
- Oblique fractures of the fibula
- Reconstructive surgeries of the foot:
- malleolar fixation
where size of offered implant is patient appropriate.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Arthrex Bio-Compression Family is currently comprised of enhanced Poly(I-Lactide) or PLLA implants in various lengths and diameters. They are offered sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Carpal, metacarpal, and small hand bone; tarsal and metatarsals; phalanges; ankle; proximal and distal humerus; proximal and distal radius; proximal and distal ulna; knee; fibula; foot.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The in house test data provided, as well as articles cited, support the use of the Arthrex Bio-Compression Family in the indications sought.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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K060478 page 1 of 2
O
510(k) Summary
| 510(k) Number: | K06XXXX |
|---|---|
| Company: | Arthrex, Inc. |
| Address: | 1370 Creekside Blvd., Naples, FL 34108-1945 |
| Telephone: | (239) 643-5553 |
| Facsimile: | (239) 598-5508 |
| Contact: | Ann Waterhouse |
| Device Name: | Arthrex Bio-Compression Family |
| Classification: | Screw, Fixation, Bone |
| Product Code: | HWC |
| Predicate Devices: |
Description:
The Arthrex Bio-Compression Family is currently comprised of enhanced Poly(I-Lactide) or PLLA implants in various lengths and diameters. They are offered sterile.
Indications for Use:
The Arthrex Bio-Compression Screw is intended for fixation of fractures, osteotomies and arthrodesis in:
(
- Carpal, metacarpal, and small hand bone .
- tarsal and metatarsals .
- phalanges .
- Intra-articular fractures ●
- ankle
- . proximal and distal humerus
- proximal and distal radius
- . proximal and distal ulna
- . osteochondral fixation and fractures
- . Osteochondritis Dissecans
- Fixation of fractures and osteotomies about the knee .
- Oblique fractures of the fibula .
- . Reconstructive surgeries of the foot
- malleolar fixation .
where size of offered implant is patient appropriate.
1
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Technical Differences:
The basis for substantial equivalence is in supporting the use of your device in the same manner as that of a competitor. The in house test data provided, as well as articles cited, support the use of the Arthrex Bio-Compression Family in the indications sought.
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 for the previously cleared indications for use. The Arthrex Bio-Compression Family of Implants does not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials used in construction of these devices are well characterized and have been used in predicate devices with similar indications.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged around the symbol in a circular fashion. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 19 2006
Arthrex, Inc. % Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K060478
Trade/Device Name: Arthrex Bio-Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 20, 2006 Received: April 21, 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.
3
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 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,
Herbert Lerner vo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 3 - Ms. Ann Waterhouse, RAC
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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Lerner
(Division Sign-Oif) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K060478
5
510(k) Number (if known):
Device Name: Arthrex Bio-Compression Screw
Indications for Use:
The Arthrex Bio-Compression Screw is intended for fixation of fractures, osteotomies and arthrodesis in:
- Carpal, metacarpal, and small hand bone
- tarsal and metatarsals
- phalanges
- Intra-articular fractures
- ankle
- proximal and distal humerus
- proximal and distal radius
- proximal and distal ulna
- osteochondral fixation and fractures
- Osteochondritis Dissecans
- Fixation of fractures and osteotomies about the knee
- Oblique fractures of the fibula
- Reconstructive surgeries of the foot:
- malleolar fixation
where size of offered implant is patient appropriate.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1_ of _1