(78 days)
No
The device description and intended use are purely mechanical/material-based, and there is no mention of AI or ML in the provided text.
Yes
The device is used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone, to repair or reconstruct damaged tissue in various anatomical sites. This direct intervention to restore function and mitigate symptoms qualifies it as therapeutic.
No
The FastThread Interference Screws are described as devices used for fixation of tissue during surgical procedures (e.g., ligament or tendon to bone). They are intended to provide mechanical support and are made of bioabsorbable materials, rather than being used for identifying or analyzing medical conditions.
No
The device description clearly states it is a physical, bioabsorbable screw made from PLDLA, Biphasic Calcium Phosphate, and hydroxyapatite, intended for surgical fixation. This is a hardware device, not software.
Based on the provided information, 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 (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Arthrex FastThread Interference Screw is a surgical implant used for fixing tissue to bone during orthopedic procedures. It is physically implanted into the body to provide mechanical support.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens taken from the patient.
Therefore, the Arthrex FastThread Interference Screw falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Arthrex FastThread Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; specifically,
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Posterior Cruciate Ligament Repair, MPFL Repair/Reconstruction
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist
Product codes
MAI, HWC
Device Description
The Arthrex FastThread Interference Screw is a cannulated, fully threaded, bioabsorbable interference screw, manufactured from PLDLA, Biphasic Calcium Phosphate and hydroxyapatite (HA). The screws measure 6-12 mm in diameter and 20-30 mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, shoulder, elbow, ankle, foot, and hand/wrist
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)
Mechanical testing demonstrated that the pull-out strength of the proposed Arthrex FastThread Interference Screw met the acceptance criterion established by K201749 for MPFL repair/reconstruction.
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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November 18, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Arthrex Inc. Jessica L. Singelais Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K202535
Trade/Device Name: Arthrex FastThread Interference Screw Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: October 22, 2020 Received: October 26, 2020
Dear Ms. Singelais:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 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.
Laura C. Rose, Ph.D. 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
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Indications for Use
510(k) Number (if known) K202535
Device Name Arthrex FastThread Interference Screw
Indications for Use (Describe)
The Arthrex FastThread Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; specifically,
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Posterior Cruciate Ligament Repair, MPFL Repair/Reconstruction
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist
| 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 | October 22, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Jessica L. Singelais |
| Regulatory Affairs Specialist | |
| 1-239-598-4302, ext. 73091 | |
| Jessica.singelais@arthrex.com | |
| Name of Device | Arthrex FastThread Interference Screw |
| Common Name | Fastener, Fixation, Biodegradable, Soft Tissue |
| Screw, fixation, bone | |
| Product Code | MAI, HWC |
| Classification Name | 888.3030 Single/multiple component metallic bone fixation appliances and |
| accessories | |
| 888.3040 Smooth or threaded metallic bone fixation fastener | |
| Regulatory Class | II |
| Predicate Device | K180662: Arthrex FastThread Interference Screw |
| Reference Device | K201749: Arthrex SwiveLock Suture Anchor |
| K173240: Arthrex PushLock | |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to expand indications for |
| the Arthrex FastThread Interference Screw cleared under K180662 to include | |
| MPFL Repair/Reconstruction. | |
| Device Description | The Arthrex FastThread Interference Screw is a cannulated, fully threaded, |
| bioabsorbable interference screw, manufactured from PLDLA, Biphasic Calcium | |
| Phosphate and hydroxyapatite (HA). The screws measure 6-12 mm in diameter | |
| and 20-30 mm in length. | |
| Comparison | |
| Summary of | |
| Technological | |
| Characteristics and | |
| Modifications | |
| Proposed | The proposed and predicate devices (K180662) have the same technological |
| characteristics (device design, sterilization and biocompatibility). Therefore, | |
| sterilization and biocompatibility data can be leveraged from the previous | |
| clearance. The proposed device modification consists of the addition of the MPFL | |
| Repair/Reconstruction indication and an extended shelf life. The shelf-life has | |
| been extended using the same methods and protocol reviewed and accepted by | |
| FDA in K173240. | |
| Indications for Use | The Arthrex FastThread Interference Screw is substantially equivalent to the |
| predicate device in which the 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 questions concerning safety or effectiveness. | |
| The Arthrex FastThread Interference Screws are intended to be used for fixation | |
| of tissue, including ligament or tendon to bone, or a bone/tendon to bone. | |
| Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, | |
| ankle, foot, and hand/wrist where the sizes offered are patient appropriate; | |
| specifically, |
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps
Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or
Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,
Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament |
| | Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon
transfers in the foot and ankle |
| | Knee : Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair,
Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique
Ligament Repair, Illiotibial Band Tenodesis, Posterior Cruciate Ligament Repair,
MPFL Repair/Reconstruction |
| | Elbow : Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction |
| | Hand/Wrist : Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament
Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint
arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions
and repairs, tendon transfer in the hand/wrist |
| Performance Data | Mechanical testing demonstrated that the pull-out strength of the proposed
Arthrex FastThread Interference Screw met the acceptance criterion established
by K201749 for MPFL repair/reconstruction. |
| | Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that
the device meets pyrogen limit specifications. |
| Conclusion | 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 device. |
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