(110 days)
Not Found
No
The device description and intended use are purely mechanical, describing titanium screws for bone fixation. There is no mention of software, algorithms, or data processing that would suggest AI/ML.
Yes.
The device is used for fixation of small bone fragments and various types of fractures and osteotomies, which are therapeutic interventions.
No
This device is a surgical implant (compression screws) used for fixation of bone fragments and fractures, not for diagnosing conditions.
No
The device description clearly states that the Arthrex Compression FT Screws are a family of titanium, cannulated, compression screws, 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 examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The Arthrex Compression FT Screws are described as titanium, cannulated, compression screws intended for the fixation of bone fragments. This is a surgical implant, not a device used for testing biological samples.
- Intended Use: The intended use clearly states the device is for "fixation of small bone fragments" and lists various anatomical locations and types of fractures/conditions where the screws are used. This is a therapeutic/surgical application, not a diagnostic one.
The information provided about the device's function, materials, and intended use all point to it being a surgical implant used for orthopedic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Arthrex Compression FT Screws are intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following:
- . Osteochondral fragments (talar vault, femoral condyle)
- . apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal)
- . cancellous fragments (talus)
- o Carpal, metacarpal, and small hand bone
- . tarsal and metatarsals
- . phalanges
- . Intra-articular fractures
- o ankle
- . proximal and distal humerus
- . proximal and distal radius
- . proximal and distal ulna
- . osteocondral 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
Product codes
HWC
Device Description
The Arthrex Compression FT Screws are a family of titanium, cannulated, compression screws that are offered in a diameter range of 2.5 to 4.0mm, length range of 32 to 60mm, in a fully threaded design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bone fragments, talar vault, femoral condyle, radial head, patellar rim, navicular, metacarpal/metatarsal, talus, Carpal, metacarpal, small hand bone, tarsal, metatarsals, phalanges, ankle, proximal and distal humerus, proximal and distal radius, proximal and distal ulna, knee, fibula, foot.
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)
Push-out, torque and compression testing were conducted to demonstrate that the proposed longer Arthrex Compression FT Screws perform statistically equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in blue, with 'ADMINISTRATION' written in a smaller font size below it.
Arthrex Inc. Rebecca Homan Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
December 18, 2018
Re: K182361
Trade/Device Name: Arthrex Compression FT Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 16, 2018 Received: November 19, 2018
Dear Rebecca Homan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Figure/7 description: The image shows a digital signature. The signature is by Jesse Muir -S. The date of the signature is 2018.12.18. The time of the signature is 14:46:11 -05'00'.
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K182361
Device Name Arthrex Compression FT Screws
Indications for Use (Describe)
The Arthrex Compression FT Screws are intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following:
- . Osteochondral fragments (talar vault, femoral condyle)
- . apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal)
- . cancellous fragments (talus)
- o Carpal, metacarpal, and small hand bone
- . tarsal and metatarsals
- . phalanges
- . Intra-articular fractures
- o ankle
- . proximal and distal humerus
- . proximal and distal radius
- . proximal and distal ulna
- . osteocondral 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
Type of Use (Select one or both, as applicable)
× | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date Prepared | December 17, 2018 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Regulatory Affairs Associate | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex Compression FT Screws |
| Common Name | Screw, fixation, bone |
| Product Code | HWC |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | ll |
| Predicate Device | K132217: Arthrex Compression FT Screws |
| K141735: Arthrex Ankle Fusion Plating System | |
| Purpose of | |
| Submission | This Special 510(k) premarket notification is submitted to obtain clearance for a |
| line extension to the Arthrex Compression Screws family cleared under K132217. | |
| Device Description | The Arthrex Compression FT Screws are a family of titanium, cannulated, |
| compression screws that are offered in a diameter range of 2.5 to 4.0mm, length | |
| range of 32 to 60mm, in a fully threaded design. | |
| Indications for Use | The Arthrex Compression FT Screws are intended for fixation of small bone |
| fragments, such as apical fragments, osteochondral fragments and cancellous | |
| fragments. Specific applications include the following: | |
| Osteochondral fragments (talar vault, femoral condyle)apical fragments (radial head, patellar rim, navicular, | |
| metacarpal/metatarsal)cancellous fragments (talus)Carpal, metacarpal and small hand bonestarsal and metatarsalsphalangesIntra-articular fracturesankleproximal and distal humerusproximal and distal radiusproximal and distal ulnaosteochondral fixation and fracturesOsteochondritis DissecansFixation of fractures and osteotomies about the kneeOblique fractures of the fibulaReconstructive surgeries of the footmalleolar fixation | |
| Technical | |
| Comparison | The Arthrex Compression FT Screws are substantially equivalent to the predicate |
| devices in which the basic design features, intended use, indications for use, | |
| material, biocompatibility, method of sterilization, packaging, and shelf-life are | |
| the same. |
The Arthrex Compression FT Screws are a line extension to the predicate devices,
which include minor dimensional modifications with no change in intended use
or function. Any differences between the Arthrex Compression FT Screws and |
| | the predicate devices are considered minor and do not raise different questions
of safety or effectiveness. |
| Performance Data | Push-out, torque and compression testing were conducted to demonstrate that
the proposed longer Arthrex Compression FT Screws perform statistically
equivalent to the predicate. |
| Conclusion | The longer Arthrex Compression FT Screws are substantially equivalent to the
predicate device in which the basic design features and intended uses are the
same. Any differences between the proposed device and the predicate device
are considered minor and do not raise different questions of safety or
effectiveness.
Based on the indications for use, technological characteristics, and data
submitted, Arthrex Inc. has demonstrated that the proposed device is
substantially equivalent to the currently marketed predicate device. |
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