(100 days)
The Arthrex PCL TightRope is intended to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.
The proposed PCL TightRope consists of an adjustable non-absorbable suture loop, and 2 titanium buttons.
The PCL TightRope is deemed substantially equivalent to the previously cleared Arthrex ACL TightRope and the Arthrex BioComposite Interference Screw. The device's substantial equivalence is supported by mechanical and biomechanical testing demonstrating comparable ultimate load and cyclic displacement to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (PCL TightRope) |
|---|---|---|
| Ultimate Load | Substantially equivalent to Arthrex BioComposite Interference Screw | Demonstrated substantial equivalence to the predicate device. |
| Cyclic Displacement | Substantially equivalent to Arthrex BioComposite Interference Screw | Demonstrated substantial equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set used in the mechanical and biomechanical testing. The data provenance is also not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study involved mechanical and biomechanical testing of a medical device, not a diagnostic or AI-driven system requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable for a study comparing mechanical and biomechanical properties of a medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, as this is a device clearance based on substantial equivalence for mechanical properties, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done
This information is not applicable. The study is on a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth implied for the study is the established mechanical and biomechanical performance (ultimate load and cyclic displacement) of the predicate device, the Arthrex BioComposite Interference Screw.
8. The Sample Size for the Training Set
This is not applicable as the study involved mechanical and biomechanical testing of a device, not a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. The study involved direct mechanical and biomechanical testing and comparison to an established predicate device, not an AI training process.
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APR 2 8 2011
K110123
1 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | January 11, 2011 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Courtney SmithRegulatory Affairs Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1720Fax: 239/598.5508Email: csmith@arthrex.com |
| Trade Name | PCL TightRope |
| Common Name | Fastener, fixation, nondegradable, soft tissueSuture, Nonabsorbable, synthetic, polyethylene |
| Product Code -ClassificationNameCFR | HTY, GAT21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener21 CFR 878.5000: Nonabsorbable poly(ethylene terephthalate) surgical suture. |
| Predicate Device | K071176: Arthrex BioComposite Interference ScrewK100652: Arthrex ACL TightRope |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted toobtain clearance for the PCL TightRope. |
| Device Description and IntendedUse | The proposed PCL TightRope consists of an adjustable non-absorbable suture loop, and 2 titanium buttons.The Arthrex PCL TightRope is intended to be used forfixation of bone to bone or soft tissue to bone, and is intendedas fixation posts, a distribution bridge, or for distributingsuture tension over areas of ligament or tendon repair. Forexample, ACL/PCL repair and reconstruction. |
| Substantial EquivalenceSummary | The PCL TightRope is substantially equivalent to thepreviously cleared Arthrex ACL TightRope, in which the basicfeatures and intended use are the same. It is substantiallyequivalent to the performance characteristics of the previouslycleared Arthrex BioComposite Interference Screw, which iscleared for the same indications. Any differences between thePCL TightRope and the predicates are considered minor anddo not raise questions concerning safety and effectiveness |
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KII DIZ 3
The proposed devices consist of a titanium button and nonabsorbable suture which is substantially equivalent to the previously cleared Arthrex ACL TightRope. The submitted data demonstrated that the mechanical and biomechanical testing of the proposed devices is substantially equivalent to the ultimate load and cyclic displacement of the previously cleared Arthrex BioComposite Interference Screw. Based on the indication for use, technological characteristics, and the comparison with the predicate devices, Arthrex, Inc. has determined that the PCL TightRope is substantially equivalent to currently marketed predicate devices.
Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like strokes, positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Inc. % Ms. Courtney Smith Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
APR 2 8 2011
Re: K110123 Trade/Device Name: Arthrex PCL TightRope Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY, GAT Dated: March 30, 2011 Received: April 5, 2011
Dear Ms. Smith:
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. Insting 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 (reporting of medical
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Page 2 - Ms. Courtney Smith
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/RcportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ay B. Rota
for
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 《 | | ○ | 乙 3
Arthrex PCL TightRope Device Name:
Indications For Use:
The Arthrex PCL TightRope is intended to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.
AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use _V (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 1
for M. Mellersor
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
5:0(k) Number K1 0123
§ 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.