(180 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the pins, with no mention of AI or ML.
Yes
The device is intended for fracture and osteotomy fixation, which are corrective procedures to treat injuries and conditions, thus providing therapy.
No
Explanation: The device description and intended use clearly state that the Arthrex Compression FT pins are used for fracture and osteotomy fixation, which are treatment procedures, not diagnostic ones. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description clearly states that the device is a family of solid, fully threaded, self-tapping, tapering head pins manufactured from Titanium Alloy. This is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Arthrex Compression FT pins are for "small bone fracture and osteotomy fixation" and "fixation of small bone fragments, osteochondral fragments and cancellous fragments." This describes a surgical implant used to stabilize bone, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details a "solid, fully threaded, self-tapping, tapering head with and without a snap-off function" made of Titanium Alloy. This is a physical implant, not a reagent, instrument, or system intended for in vitro use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
The device is a surgical implant used for orthopedic fixation.
N/A
I. Intended Use / Indications for Use
The Arthrex Compression FT Pins (1.9 mm) are intended for small bone fracture and osteotomy fixation in the hand, wrist, foot, ankle and knee.
The Arthrex Compression FT Pins (2.4 mm) 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 bone Tarsal and metatarsals Phalanges Intra-articular fractures 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 (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Arthrex Compression FT Pins are a family of solid, fully threaded, self-tapping, tapering head with and without a snap-off function designed to provide fixation of fractures, osteotomies and arthrodesis. The pins are offered in two diameters: 1.9 mm and 2.4 mm, and range in lengths from 10 mm to 50 mm. The pins are manufactured from Titanium Alloy, conforming to ASTM F136. The pins 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
hand, wrist, foot, ankle, knee, talar vault, femoral condyle, radial head, patellar rim, navicular, metacarpal/metatarsal, talus, carpal, metacarpal, small hand bone, tarsal, metatarsals, phalanges, humerus, radius, ulna, fibula
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)
Arthrex conducted Axial Pull-out (ASTM F543-17), Compression, Failure Torque/ Insertion Torque (ASTM F543-17), Snapping and Shear testing to demonstrate that the 2.4 mm Arthrex Compression FT Pins perform statistically equivalent to the primary predicate devices cleared under K132217 and additional predicate devices cleared under K182361. Arthrex performed engineering analyses to conclude that the Failure Torque and Insertions Torque values of the Arthrex Compression FT Pins were acceptable. Arthrex used the Safety and Performance Based Pathway to support substantial equivalence of the Axial Pull-out of the 1.9 mm Arthrex Compression FT Pins.
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 F2182 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 Compression FT Pins utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2019, USP , USP , EP 2.6.14. The testing conducted demonstrates that the sterile devices within the Arthrex Compression FT Pins 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 Compression FT Pins in accordance with ISO 10993-1:2018.
Assessment of physical product attributes including product, design, size, and materials has determined that the Arthrex Compression FT Pins do not introduce additional risks or concerns regarding sterilization and shelf-life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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.
0
September 19, 2022
Image /page/0/Picture/1 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Arthrex Inc. Rebecca Homan Team Lead, Regulatory Affairs-Product Development 1370 Creekside Boulevard Naples. Florida 34108-1945
Re: K220839
Trade/Device Name: Arthrex Compression FT Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 2, 2022 Received: March 23, 2022
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
For: Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Arthrex Compression FT Pins
Indications for Use (Describe)
The Arthrex Compression FT pins (1.9 mm) are intended for small bone fracture and osteotomy fixation in the hand, wrist, foot, ankle and knee.
The Arthrex Compression FT pins (2.4 mm) are intended for fixation of small bone fragments, osteochondral fragments and cancellous fragments. Specific applications include the following:
- Osteochondral fragments
- · Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal)
- · Cancellous fragments
- · 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
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K220839
510(k) Summary
| Date Prepared | September 16, 2022 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Team Lead, Regulatory Affairs - Product Development | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex Compression FT Pins |
| Common Name | Screw, fixation, bone |
| Product Code | HWC |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fastener |
| Regulatory Class | II |
| Primary Predicate Device | K132217: Arthrex Compression FT Screws |
| Additional Predicate | |
| Devices | K182361: Arthrex Compression FT Screws |
| Reference Devices | K201132: Arthrex Compression Screws |
| K210994: Arthrex Beveled FT Screws | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain |
| clearance for the Arthrex Compression FT Pins. | |
| Device Description | The Arthrex Compression FT Pins are a family of solid, fully threaded, self- |
| tapping, tapering head with and without a snap-off function designed to | |
| provide fixation of fractures, osteotomies and arthrodesis. The pins are | |
| offered in two diameters: 1.9 mm and 2.4 mm, and range in lengths from 10 | |
| mm to 50 mm. The pins are manufactured from Titanium Alloy, conforming | |
| to ASTM F136. The pins are sold sterile and non-sterile and are single use. | |
| Indications for Use | The Arthrex Compression FT Pins (1.9 mm) are intended for small bone |
| fracture and osteotomy fixation in the hand, wrist, foot, ankle and knee. |
The Arthrex Compression FT Pins (2.4 mm) 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 bone Tarsal and metatarsals Phalanges Intra-articular fractures 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
• |
| Performance Data | Arthrex conducted Axial Pull-out (ASTM F543-17), Compression, Failure |
| | Torque/ Insertion Torque (ASTM F543-17), Snapping and Shear testing to
demonstrate that the 2.4 mm Arthrex Compression FT Pins perform
statistically equivalent to the primary predicate devices cleared under
K132217 and additional predicate devices cleared under K182361. Arthrex
performed engineering analyses to conclude that the Failure Torque and
Insertions Torque values of the Arthrex Compression FT Pins were
acceptable. Arthrex used the Safety and Performance Based Pathway to
support substantial equivalence of the Axial Pull-out of the 1.9 mm Arthrex
Compression FT Pins. |
| | 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
F2182 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 Compression
FT Pins utilizing the Kinetic Chromogenic Method in accordance with
ANSI/AAMI ST72:2019, USP , USP , EP 2.6.14. The testing
conducted demonstrates that the sterile devices within the Arthrex
Compression FT Pins 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 Compression FT
Pins in accordance with ISO 10993-1:2018. |
| | Assessment of physical product attributes including product, design, size,
and materials has determined that the Arthrex Compression FT Pins do not
introduce additional risks or concerns regarding sterilization and shelf-life. |
| Technological
Comparison | The Arthrex Compression FT Pins are substantially equivalent to the primary
predicate devices cleared under K132217; additional predicate devices
cleared under K182361; and reference devices cleared under K201132 and
K210994 in which the basic design features, intended use, fundamental
scientific technology, materials, sterility, packaging and shelf-life are
identical. |
| | The Arthrex Compression FT Pins are a family of solid, fully threaded, self-
tapping, tapering head with a snap-off design. The pins are offered in two
diameters: 1.9 mm and 2.4 mm, and range in lengths from 10 mm to 50 mm.
The pins are manufactured from Titanium Alloy. The pins are sold sterile and
non-sterile and are single use. |
| | |
| | The primary predicate device Arthrex Compression FT Screws cleared under
K132217 are fully threaded, cannulated screws with self-tapping, tapering
head. The screws were cleared in diameters ranging from 2.5 mm to 4.0 mm
and lengths ranging from 8 mm to 50 mm. The screws are manufactured
from Titanium Alloy. The screws are sold non-sterile and are single use.
The additional predicate device Arthrex Compression FT Screws cleared
under K182361 are fully threaded, cannulated screws with self-tapping,
tapering head. The screws were cleared in diameters ranging from 2.5 mm
to 4.0 mm and lengths ranging from 32 mm to 60 mm. The screws are
manufactured from Titanium Alloy. The screws are sold non-sterile and are
single use. |
| | The reference device 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 screws are manufactured from
Titanium Alloy and Stainless Steel. The screws are sold sterile and non-
sterile and are single use. |
| | The Arthrex Compression FT Pins are sold sterile and non-sterile as were the
reference devices cleared under K201132 and K210994. |
| | The Arthrex Compression FT Pins were evaluated for MR Conditional labeling
as were the reference devices cleared under K201132 and K210994. |
| | The Arthrex Compression FT Pins are substantially equivalent to the primary
predicate devices cleared under K132217; additional predicate devices
cleared under K182361; and reference devices cleared under K201132 and
K210994, with minor dimensional modifications with no change to intended
use or function. Any differences between the Arthrex Compression FT Pins
and the predicate devices are considered minor and do not raise different
questions of safety or effectiveness. |
| Conclusion | The Arthrex Compression FT Pins are substantially equivalent to the primary
predicate devices cleared under K132217; additional predicate devices
cleared under K182361; and reference devices cleared under K201132 and
K210994; in which the basic design features and intended use are the same.
Any differences between the Arthrex Compression FT Pins 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 Axial Pull-out,
Compression, Shear and Torsion strength of the Arthrex Compression FT
Pins System is substantially equivalent to that of the predicate devices for
the desired 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. |
4
5