(23 days)
Not Found
No
The description focuses on the mechanical properties and intended use of a surgical screw, with no mention of AI or ML technologies.
No.
The device is an implantable screw intended for fixation of bony or chondral fragments and fractures, which is a structural or supportive function rather than a therapeutic one that treats a disease or condition actively.
No
The provided text describes a medical implant (a screw) used for fixation of bones and fragments. Its function is therapeutic/restorative (to fix bones), not to diagnose a condition.
No
The device description clearly states it is an "implant" and describes its physical characteristics and how it is inserted, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes the Arthrex RetroFusion Screw as a surgical implant intended to fix bones and bone fragments within the body. It is used in surgical procedures for orthopedic conditions.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens taken from a patient.
Therefore, based on the provided information, the Arthrex RetroFusion Screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex RetroFusion Screw is intended 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 devices are used in cases of osteochondritis dissecans and osteochondral fragments, fixation of fractures, 1st metatarsal (bunionectomy osteotomies), cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The devices 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. This device is also used in inherently stable long bone fractures such as the femur, fibula, tibia, radius and ulna, including the diaphyseal, epiphyseal, and metaphyseal areas.
Product codes
HWC
Device Description
The Arthrex RetroFusion Screw is an implant with a dual threaded design and ranges in size from 20 to 32mm in length. The RetroFusion screw is inserted between the proximal and middle phalanges, so the opposing threads fixate on the phalangeal canal of the toe and compress the joint.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, upper extremities, hand, wrist, phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, femur, fibula, tibia, radius, ulna
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
Pull-out testing demonstrates that the pull-out strength of the Arthrex RetroFusion Screw is significantly greater than the predicate.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design. The caduceus symbol is a common symbol for healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2015
Arthrex, Inc. Mr. David Rogers Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K151078
Trade/Device Name: Arthrex RetroFusion 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, 2015 Received: April 22, 2015
Dear Mr. Rogers:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Arthrex RetroFusion Screw
Indications for Use (Describe)
The Arthrex RetroFusion Screw is intended 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 devices are used in cases of osteochondritis dissecans and osteochondral fragments, fixation of fractures, 1st metatarsal (bunionectomy osteotomies), cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The devices can be used for inherently stablization of ioint arthroplasty (resection) or fusion for the treatment of divital deformities of the foot or hand. This device is also used in inherently stable long bone fractures such as the femur, fibula, tibia, radius and ulna, including the diaphyseal, epiphyseal, and metaphyseal areas.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| Date Summary Prepared | April 20, 2015 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | David L Rogers |
| Regulatory Affairs Associate | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 71924 | |
| Fax: 239/598.5508 | |
| Email: david.rogers@Arthrex.com | |
| Trade Name | Arthrex RetroFusion Screw |
| Common Name | Screw |
| Product Code -Classification Name | HWC - Screw, Fixation, Bone |
| CFR | 21 CFR 888.3040: Smooth or threaded metallic bone |
| fixation fastener | |
| Predicate Device | K050259: Arthrex Bio-Pin |
| Purpose of Submission | This special 510(k) premarket notification is submitted to |
| obtain FDA clearance for the Arthrex RetroFusion Screw. | |
| Device Description | The Arthrex RetroFusion Screw is an implant with a dual |
| threaded design and ranges in size from 20 to 32mm in | |
| length. The RetroFusion screw is inserted between the | |
| proximal and middle phalanges, so the opposing threads | |
| fixate on the phalangeal canal of the toe and compress | |
| the joint. | |
| Intended Use | The Arthrex RetroFusion Screw is intended 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 | |
| devices are used in cases of osteochondritis dissecans | |
| and osteochondral fragments, fixation of fractures, 1st | |
| metatarsal (bunionectomy osteotomies), cuneiform | |
| bones, inherently stable osteotomies, and fusions of the | |
| phalanges, metatarsals, metacarpals, carpal bones, tarsal | |
| bones, ankle, and wrist. The devices 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. This device is also | |
| used in inherently stable long bone fractures such as the | |
| femur, fibula, tibia, radius and ulna, including the | |
| diaphyseal, epiphyseal, and metaphyseal areas. | |
| Substantial Equivalence Summary | The Arthrex RetroFusion Screw is substantially equivalent |
| to the predicate devices in which the basic design | |
| features and intended uses are the same. | |
| Any | |
| differences between the Arthrex RetroFusion Screw and | |
| the predicate are considered minor and do not raise | |
| questions concerning safety and effectiveness. | |
| Pull-out testing demonstrates that the pull-out strength | |
| of the Arthrex RetroFusion Screw is significantly greater | |
| than the predicate. | |
| Based on the indications for use, technological | |
| characteristics, and the summary of data submitted, | |
| Arthrex, Inc. has determined that the Arthrex | |
| RetroFusion Screw is substantially equivalent to the | |
| predicates. |
2.6 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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