(191 days)
The Arthrex SwiveLock Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip 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: 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
The SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. FiberWire suture may also be provided with the device.
The provided 510(k) summary (K101823) describes the Arthrex SwiveLock Anchors, a medical device intended for fixing suture (soft tissue) to bone in various anatomical regions. The device is seeking substantial equivalence to previously marketed predicate devices.
1. Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for the Arthrex SwiveLock Anchors are based on demonstrating substantial equivalence to existing predicate devices. Since this is an equivalence submission, specific quantitative acceptance criteria for absolute performance metrics are not explicitly stated in the summary. Instead, the performance is compared against the known performance of the predicate devices.
The study aimed to demonstrate that the SwiveLock Anchors perform comparably to the predicate devices in terms of:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Degradation (for Bio/BioComposite materials) | 26-week degradation data demonstrated substantial equivalence. |
| Mechanical Pull-Out (Tensile) Strength | Mechanical pull-out (tensile) testing data demonstrated substantial equivalence to the pull-out forces of the predicate devices. |
| Insertion Characteristics | Insertion testing data demonstrated substantial equivalence. |
| In-vivo Performance (Histology, Pull-Out, Imaging) | Animal testing (including histology, in-vivo pull-out, and in-vivo imaging) data demonstrated no new issues of safety and effectiveness, implying comparable in-vivo performance. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each test mentioned (degradation, mechanical pull-out, insertion, animal testing). It only refers to "data" for each category.
The data provenance is not specified. It is an industry standard to conduct these tests in a controlled laboratory environment or animal models. Neither the country of origin nor whether the data is retrospective or prospective is mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable to this type of 510(k) submission. Establishing "ground truth" by experts is typically relevant for diagnostic or AI-driven devices where human interpretation is involved. For a mechanical device like a suture anchor, the "truth" is established through physical and biological testing against established standards or predicate device performance.
4. Adjudication Method:
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers/experts in diagnostic studies, which is not relevant for the mechanical and biological testing of a suture anchor.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the effect of AI assistance on their performance is evaluated.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used:
The "ground truth" in this context is established through physical and biological testing methodologies. This includes:
- Degradation data: Measuring the breakdown of biomaterials over time.
- Mechanical pull-out (tensile) testing data: Quantifying the force required to pull the anchor out of bone, adhering to engineering standards.
- Insertion testing data: Assessing the ease and characteristics of device insertion.
- Animal testing data: Observing the biological response (histology), in-vivo pull-out strength, and imaging of the device in a living system.
The "truth" is rooted in the physical and biological properties and performance of the device as measured by these tests, compared against the known performance of predicate devices.
8. Sample Size for the Training Set:
This information is not applicable. "Training set" refers to data used to train machine learning algorithms. The Arthrex SwiveLock Anchor is a mechanical device, not an AI or algorithm-driven system.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above.
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K101823(1/2)
:
3 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | January 6, 2011 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Sally Foust, RACRegulatory Affairs Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1251Fax: 239/598.5508Email: sfoust@arthrex.comCourtney SmithRegulatory Affairs Project ManagerTelephone: 239/643.5553, ext. 1720Fax: 239/598.5508Email: csmith@arthrex.com |
| Trade Name | SwiveLock Anchors |
| Common Name | Suture Anchor |
| Product Code -Classification | HWC, MAI |
| NameCFR | 21 CFR 888.3040: Smooth or threaded metallic bonefixation fastener.21 CFR 888.3030: Single/multiple component metallicbone fixation appliances and accessories. |
| Predicate Device | K082810: Arthrex BioComposite Suture AnchorsK061863: Arthrex PushLock, Tak and Corkscrew SutureAnchorsK051726: Arthrex Tenodesis Family |
| Device Description and IntendedUse | The SwiveLock Anchor is a two-component, knotlesssuture anchor comprised of an eyelet and a hollow anchorbody. The SwiveLock Anchor is pre-mounted on a driverwith the anchor body and eyelet physically separated onthe driver shaft. FiberWire suture may also be providedwith the device.The Arthrex SwiveLock Anchor is intended for fixation ofsuture (soft tissue) to bone in the shoulder, foot/ankle |
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K101823($^{2}/_{2}$)
| procedures. Refer to the Indications For Use Form forspecific indications for use. | JAN - 7 2011 | ||
|---|---|---|---|
| Substantial EquivalenceSummary | The Arthrex SwiveLock Anchors are substantiallyequivalent to the Arthrex BioComposite SutureAnchors, Arthrex PushLock, Tak and CorkscrewSuture Anchors, and Arthrex Tenodesis Familypredicates, in which the basic features and intended usesare the same. Any differences between the SwiveLockAnchors and the predicates are considered minor and donot raise questions concerning safety and effectiveness. | ||
| The proposed devices are composed of Bio,BioComposite, Peek, and Titanium materials that aresubstantially equivalent to the predicate devices. | |||
| The submitted 26-week degradation data, mechanical pull-out (tensile) testing data, insertion testing data, animaltesting (including histology, in-vivo pull-out and in-vivoimaging) data demonstrated that the proposed devices aresubstantially equivalent to the pull-out forces of thepredicate devices and that there are no new issues of safetyand effectiveness. | |||
| Based on the indication for use, technologicalcharacteristics, degradation testing, mechanical pull-outtesting, insertion testing, animal testing (includinghistology, in-vivo pull-out and in-vivo imaging) and designcomparison to the predicate devices, Arthrex, Inc. hasdetermined that the SwiveLock Anchors are substantiallyequivalent to currently marketed predicate devices. |
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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 features a stylized depiction of an eagle or bird-like figure with three horizontal lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Inc. % Ms. Sally Foust Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
JAN - 7 2017
Re: K101823
Trade/Device Name: Arthrex Swivelock Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MAI, HWC Dated: January 5, 2011 Received: January 6, 2011
Dear Ms. Foust:
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 indicions 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 Amendmants, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr to 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, incring of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
and the contract of the country of the country of the county of
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Page 2 - Ms. Sally Foust
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.
ff 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/CDRHQffices/ucm115809.html 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/ReportaProblem/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,
Mark N Melkerson
Director
Division of Surgical, Orthopedic,
and Restorative Devices
and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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dications for Use Form
Indications for Use
| 510(k) Number (if known): | K101823 | JAN - 7 2011 |
|---|---|---|
| Device Name: | Arthrex SwiveLock Anchors | |
| Indications For Use: |
The Arthrex SwiveLock Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip 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: | 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 |
Prescription Use _ V _ AND/OR Over-The-Counter Use _____ (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(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. Meikerson
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
ત્ત્વ
510(k) Number K100823
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§ 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.