(60 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a bone screw, with no mention of AI or ML technology.
No.
The device is a surgical implant (screw) used for fixation of bone reconstruction, which serves as a structural support rather than providing therapeutic treatment itself.
No
The device is a surgical screw used for bone fixation and reconstruction, not for diagnosis.
No
The device description clearly states that the device is a physical screw made of Titanium Alloy, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of bone reconstruction" in the foot or hand, listing various surgical procedures. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The description details a physical implant (screws) made of titanium alloy, designed for surgical insertion. This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Testing Performed: The testing described (mechanical testing, MRI compatibility, biocompatibility) is relevant to the safety and performance of a surgical implant, not an IVD.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Arthrex Beveled FT Screws are implanted in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
The Arthrex Beveled FT Screws are indicated for fixation of bone reconstruction. Examples include:
- . Mono or Bi-Cortical osteotomies in the foot or hand
- . Distal or Proximal metatarsal or metacarpal osteotomies
- . Weil osteotomy
- . Fusion of the first metatarsophalangeal joint and interphalangeal joint
- . Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- Akin type osteotomy
- Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus .
- . Calcaneus/cuboid arthrodesis
- Talar/navicular arthrodesis
Product codes
HWC
Device Description
The Arthrex Beveled FT Screws are fully threaded, cannulated screws with self-tapping, tapering head. The screws will be offered in three diameters: 3.5 mm, 4.0 mm and 4.5 mm, and will range in lengths from 12 mm to 60 mm. The screws are manufactured from Titanium Alloy, conforming to ASTM Standards F1472. The screws are sold sterile and non-sterile and are single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot or hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Arthrex conducted Pull-out, Push-out, Failure Torque, Insertion Torque (ASTM F543-17) and 3-Point Bend (ASTM F382-17) testing to demonstrate that the Arthrex Beveled FT Screws perform statistically equivalent to the predicate devices cleared under K162353 and K201132. Arthrex performed engineering analyses to conclude that the Failure Torque and Insertions Torque values of the Arthrex Beveled FT Screws were acceptable.
MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants ASTM E2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
Bacterial Endotoxins Test (BET) was performed on the Arthrex Beveled FT Screws utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. The testing conducted demonstrates that the sterile devices within the Arthrex Beveled FT Screws meet pyrogen limit specifications.
Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing was conducted on the devices within the Arthrex Beveled FT Screws in accordance with ISO 10993-1:2018.
Assessment of physical product attributes including product, design, size, and materials has determined that the Arthrex Beveled FT Screws do not introduce additional risks or concerns regarding sterilization and shelf-life.
The submitted mechanical testing data demonstrates that the Pull-out, Push-out, and 3-Point Bend strength of the Arthrex Beveled FT Screws System is substantially equivalent to that of the predicate devices for the desired indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
June 1, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Arthrex Inc. Rebecca Homan Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K210994
Trade/Device Name: Arthrex Beveled 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: April 1, 2021 Received: April 2, 2021
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Arthrex Beveled FT Screws
Indications for Use (Describe)
The Arthrex Beveled FT Screws are indicated for fixation of bone reconstruction. Examples include:
- . Mono or Bi-Cortical osteotomies in the foot or hand
- . Distal or Proximal metatarsal or metacarpal osteotomies
- . Weil osteotomy
- . Fusion of the first metatarsophalangeal joint and interphalangeal joint
- . Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- Akin type osteotomy
- Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus .
- . Calcaneus/cuboid arthrodesis
- Talar/navicular arthrodesis
| 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 | April 1, 2021 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Senior Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex Beveled FT Screws |
| Common Name | Screw, fixation, bone |
| Product Code | HWC |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fastener |
| Regulatory Class | II |
| Predicate Device | K162353: Wright Medical MICA Screw System |
| Reference Device | K201132: Arthrex Compression Screws |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex Beveled FT Screws. | |
| Device Description | The Arthrex Beveled FT Screws are fully threaded, cannulated screws with self- |
| tapping, tapering head. The screws will be offered in three diameters: 3.5 mm, | |
| 4.0 mm and 4.5 mm, and will range in lengths from 12 mm to 60 mm. The screws | |
| are manufactured from Titanium Alloy, conforming to ASTM Standards F1472. | |
| The screws are sold sterile and non-sterile and are single use. | |
| Indications for Use | The proposed Arthrex Beveled FT Screws are indicated for fixation of bone |
| fractures or for bone reconstruction. Examples include: | |
| • Mono or Bi-Cortical osteotomies in the foot or hand | |
| • Distal or Proximal metatarsal or metacarpal osteotomies | |
| • Weil osteotomy | |
| • Fusion of the first metatarsophalangeal joint and interphalangeal | |
| joint | |
| • Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, | |
| Chevron, etc.) | |
| • Akin type osteotomy | |
| • Arthrodesis base first metatarsal cuneiform joint to reposition and | |
| stabilize metatarsus varus primus | |
| • Calcaneus/cuboid arthrodesis | |
| • Talar/navicular arthrodesis | |
| Performance Data | Arthrex conducted Pull-out, Push-out, Failure Torque, Insertion Torque (ASTM |
| F543-17) and 3-Point Bend (ASTM F382-17) testing to demonstrate that the | |
| Arthrex Beveled FT Screws perform statistically equivalent to the predicate | |
| devices cleared under K162353 and K201132. Arthrex performed engineering | |
| analyses to conclude that the Failure Torque and Insertions Torque values of the | |
| Arthrex Beveled FT Screws were acceptable. |
MRI force, torque, and image artifact testing were conducted in accordance with
FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic
Resonance (MR) Environment, ASTM F2052 Standard Test Method for
Measurement of Magnetically Induced Displacement Force on Medical Devices in
the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for
Evaluation of MR Image Artifacts from Passive Implants ASTM E2182 Standard |
| | Test Method for Measurement of Measurement of Radio Frequency Induced |
| | Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM
F2213 Standard Test Method for Measurement of Magnetically Induced Torque
on Medical Devices in the Magnetic Resonance Environment. |
| | Bacterial Endotoxins Test (BET) was performed on the Arthrex Beveled FT Screws
utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI
ST72:2011/(R)2016, USP , USP , EP 2.6.14. The testing conducted
demonstrates that the sterile devices within the Arthrex Beveled FT Screws meet
pyrogen limit specifications. |
| | Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity,
Subchronic/Subacute Toxicity, Implantation and Material Characterization testing
was conducted on the devices within the Arthrex Beveled FT Screws in
accordance with ISO 10993-1:2018. |
| | Assessment of physical product attributes including product, design, size, and
materials has determined that the Arthrex Beveled FT Screws do not introduce
additional risks or concerns regarding sterilization and shelf-life. |
| | Technological
Comparison |
| | The Arthrex Beveled FT Screws are substantially equivalent to the predicate
devices cleared under K162353 and K201132 in which the basic design features,
intended use, fundamental scientific technology, materials, sterility, packaging
and shelf-life are identical. |
| | The Arthrex Beveled FT Screws are fully threaded, cannulated screws with self-
tapping, tapering head. The screws will be offered in three diameters: 3.5 mm,
4.0 mm and 4.5 mm, and will range in lengths from 12 mm to 60 mm. The
predicate Wright Medical MICA Screws cleared under K162353 are fully
threaded, cannulated screws with self-tapping, tapering head. The screws were
cleared in diameters ranging from 3.0 mm to 4.0 mm and lengths ranging from 32
mm to 48 mm. The predicate Arthrex Compression Screws cleared under
K201132 are fully threaded, cannulated screws with self-tapping, tapering head.
The screws were cleared in diameters ranging from 2.4 mm to 4.5 mm and
lengths ranging from 10 mm to 80 mm. |
| | The Arthrex Beveled FT Screws were evaluated for MR Conditional labeling as
were the predicate devices cleared under K201132. |
| | The Arthrex Beveled FT Screws are substantially equivalent to the predicate
devices cleared under K162353 and K201132, with minor dimensional
modifications with no change to intended use or function. Any differences
between the Arthrex Beveled FT Screws and the predicate devices are considered
minor and do not raise different questions of safety or effectiveness. |
| | Conclusion |
| | The Arthrex Beveled FT Screws are substantially equivalent to the predicate
devices cleared under K162353 and 201132; in which the basic design features
and intended use are the same. Any differences between the Arthrex Beveled FT
Screws and the predicate devices are considered minor and do not raise different
questions of safety or effectiveness. |
| | The submitted mechanical testing data demonstrates that the Pull-out, Push-out,
and 3-Point Bend strength of the Arthrex Beveled FT Screws System is
substantially equivalent to that of the predicate devices for the desired |
4
5
| indications. |
|---|
| Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate devices. |