(77 days)
Not Found
No
The summary describes a mechanical suture anchor and its intended uses, with no mention of AI or ML technology.
No
This device is a suture anchor used for fixation of soft tissue to bone during surgical repairs; it facilitates the healing process but does not directly treat or prevent a disease or condition.
No
The device description indicates it is a suture anchor intended for fixation of suture to bone during surgical repairs, not for diagnosing medical conditions.
No
The device description clearly states it is a physical suture anchor made of PLLA/BTCP, pre-loaded with suture on a disposable inserter. This is a hardware device, 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 describes a device used for the fixation of suture to bone during surgical procedures in various anatomical locations. This is a surgical implant/device, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a suture anchor made of PLLA/BTCP, pre-loaded with suture, and used with a disposable inserter. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
Therefore, the Arthrex Corkscrew FT is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Arthrex Corkscrew FT is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:
- . 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/Tendon Repair, Bunionectomy.
- . Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
- . Hand/Wrist: Scapholunate Ligament Reconstruction, Unar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
- . Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
- . Hip: Capsular Repair, acetabular labral repair.
Product codes (comma separated list FDA assigned to the subject device)
MAI
Device Description
The Arthrex Corkscrew FT is a fully threaded, vented suture anchor pre-loaded with Arthrex Suture on a disposable inserter. The anchor is manufactured from PLLA/BTCP and is offered sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, hip, knee, hand/wrist, and elbow
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)
Tensile testing was conducted after 26 weeks degradation to demonstrate that the pull-out force of the device is equivalent to the predicate.
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): 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.
Not Found
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
§ 888.3030 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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 1, 2018
Arthrex Inc. David L. Rogers Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K173788
Trade/Device Name: Arthrex Corkscrew FT Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: January 29, 2018 Received: January 30, 2018
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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1000-1050.
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
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.
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,
Vincent J. Devlin -S
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) K173788
Device Name Arthrex Corkscrew FT
Indications for Use (Describe)
The Arthrex Corkscrew FT is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:
- . 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/Tendon Repair, Bunionectomy.
- . Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
- . Hand/Wrist: Scapholunate Ligament Reconstruction, Unar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
- . Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
- . Hip: Capsular Repair, acetabular labral repair.
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 | February 27, 2018 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | David L Rogers |
| Project Manager, Regulatory Affairs | |
| 1-239-643-5553, ext. 71924 | |
| david.rogers@arthrex.com | |
| Name of Device | Arthrex Corkscrew FT |
| Common Name | Suture Anchor |
| Product Code | MAI |
| Classification Name | 21 CFR 888.3030: Fastener, Fixation, Biodegradable, Soft Tissue |
| Regulatory Class | II |
| Predicate Device | K082810: Arthrex BioComposite Suture Anchors |
| K061665: Arthrex Corkscrew FT | |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to add a line extension to |
| the Arthrex BioComposite Anchors cleared under predicate K082810. | |
| Device Description | The Arthrex Corkscrew FT is a fully threaded, vented suture anchor pre-loaded |
| with Arthrex Suture on a disposable inserter. The anchor is manufactured from | |
| PLLA/BTCP and is offered sterile. | |
| Indications for Use | The Arthrex Corkscrew FT is intended for fixation of suture (soft tissue) to bone in |
| the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following | |
| procedures: | |
| • 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, Mid-foot reconstruction, Metatarsal Ligament | |
| Repair/Tendon Repair, Bunionectomy. | |
| • Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, | |
| Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique | |
| Ligament Repair, Iliotibial Band Tenodesis. | |
| • Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial | |
| Collateral Ligament Reconstruction, Radial Collateral Ligament | |
| Reconstruction. | |
| • Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial | |
| collateral Ligament Reconstruction, Lateral Epicondylitis Repair. | |
| • Hip: Capsular Repair, acetabular labral repair. | |
| Performance Data | Tensile testing was conducted after 26 weeks degradation to demonstrate that |
| the pull-out force of the device is equivalent to the predicate. |
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that
the device meets pyrogen limit specifications. |
| Conclusion | Arthrex Corkscrew FT is 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 questions concerning safety or effectiveness. |
| | Based on the indications for use, technological characteristics, and the summary
of data submitted, Arthrex Inc. has determined that the Arthrex Corkscrew FT is
substantially equivalent to the currently marketed predicate device. |
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