(191 days)
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities. There is no mention of AI, ML, image processing, or data analysis.
Yes
The device is intended for fixation of suture to bone in various painful or injured anatomical regions to facilitate repair and recovery, which aligns with the definition of a therapeutic device.
No
The provided text describes a medical device called the Arthrex SwiveLock Anchor, which is intended for fixating suture to bone during various surgical procedures. There is no mention of the device being used to diagnose conditions or diseases; it is an implantable surgical aid.
No
The device description clearly describes a physical, implantable medical device (suture anchor) and its components, not a software-only product.
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 surgical device used for fixing suture to bone in various anatomical locations. This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implantable device (anchor) and associated components for surgical use. It does not mention any reagents, test strips, or equipment for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using diagnostic techniques like immunoassays, molecular diagnostics, or clinical chemistry.
The device is a surgical implant used for mechanical fixation during procedures.
N/A
Intended Use / 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
Product codes
HWC, MAI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, knee, hand/wrist, elbow, and hip
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)
The submitted 26-week degradation data, mechanical pull-out (tensile) testing data, insertion testing data, animal testing (including histology, in-vivo pull-out and in-vivo imaging) data demonstrated that the proposed devices are substantially equivalent to the pull-out forces of the predicate devices and that there are no new issues of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
K101823(1/2)
:
3 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | January 6, 2011 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Sally Foust, RAC |
| Regulatory Affairs Project Manager | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1251 | |
| Fax: 239/598.5508 | |
| Email: sfoust@arthrex.com |
Courtney Smith
Regulatory Affairs Project Manager
Telephone: 239/643.5553, ext. 1720
Fax: 239/598.5508
Email: csmith@arthrex.com |
| Trade Name | SwiveLock Anchors |
| Common Name | Suture Anchor |
| Product Code -Classification | HWC, MAI |
| Name
CFR | 21 CFR 888.3040: Smooth or threaded metallic bone
fixation fastener.
21 CFR 888.3030: Single/multiple component metallic
bone fixation appliances and accessories. |
| Predicate Device | K082810: Arthrex BioComposite Suture Anchors
K061863: Arthrex PushLock, Tak and Corkscrew Suture
Anchors
K051726: Arthrex Tenodesis Family |
| Device Description and Intended
Use | 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 Arthrex SwiveLock Anchor is intended for fixation of
suture (soft tissue) to bone in the shoulder, foot/ankle |
1
K101823($^{2}/_{2}$)
| | procedures. Refer to the Indications For Use Form for
specific indications for use. | JAN - 7 2011 | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--|
| Substantial Equivalence
Summary | The Arthrex SwiveLock Anchors are substantially
equivalent to the Arthrex BioComposite Suture
Anchors, Arthrex PushLock, Tak and Corkscrew
Suture Anchors, and Arthrex Tenodesis Family
predicates, in which the basic features and intended uses
are the same. Any differences between the SwiveLock
Anchors and the predicates are considered minor and do
not raise questions concerning safety and effectiveness. | | |
| | The proposed devices are composed of Bio,
BioComposite, Peek, and Titanium materials that are
substantially equivalent to the predicate devices. | | |
| | The submitted 26-week degradation data, mechanical pull-
out (tensile) testing data, insertion testing data, animal
testing (including histology, in-vivo pull-out and in-vivo
imaging) data demonstrated that the proposed devices are
substantially equivalent to the pull-out forces of the
predicate devices and that there are no new issues of safety
and effectiveness. | | |
| | Based on the indication for use, technological
characteristics, degradation testing, mechanical pull-out
testing, insertion testing, animal testing (including
histology, in-vivo pull-out and in-vivo imaging) and design
comparison to the predicate devices, Arthrex, Inc. has
determined that the SwiveLock Anchors are substantially
equivalent to currently marketed predicate devices. | | |
2
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
3
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
4
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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