(129 days)
Not Found
No
The 510(k) summary describes a mechanical suture anchor device and its intended uses. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on biomechanical and mechanical testing, not algorithmic performance.
No.
The device is an orthopedic anchoring system used for tissue fixation, which aids in repair after injury or surgery, rather than actively treating a disease or condition itself.
No.
The document states that the device is intended for "suture (soft tissue) to bone" in various repair procedures, which are therapeutic interventions rather than diagnostic ones.
No
The device description and intended use clearly describe a physical implant (anchors) used for surgical fixation of soft tissue to bone. There is no mention of software as the primary or sole component of the device.
No, 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 for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes the Arthrex PushLock Anchors as devices intended for suture (soft tissue) to bone fixation during surgical procedures in various anatomical locations. This is a surgical implant, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, diagnostic purposes, or laboratory use, which are hallmarks of IVDs.
Therefore, based on the provided information, the Arthrex PushLock Anchors are surgical implants used for tissue fixation, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Arthrex PushLock™ Anchors are intended to be used for suture (soft tissue) to bone in the shoulder, foot, ankle, knee, hand, wrist, elbow, hip, and pelvis in the following procedures:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Foot/Ankle: Repair, Repair/Tendon Hallux Valgus Reconstruction, Mid-foot Reconstruction, 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 Elbow. Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collament Reconstruction, Lateral Epicondylitis Repair
Hip: Acetabular Labral Repair.
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device Description
The Arthrex PushLock Anchors family is similar to the predicate devices in materials and overall design. The Arthrex PushLock Anchors family is intended to be used for sutures or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, hip. Please see indications for use form for specific indications.
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, hip, and pelvis
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)
biomechanical and mechanical testing (insertion and pull-out strength) of the proposed devices is substantially equivalent to the biomechanical and mechanical testing of the predicate devices.
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.
K091844: Arthrex Bio-Composite Suture Tak Anchors, K082810: Arthrex BioComposite Suture Anchors, K061863: Arthrex PushLock, Tak and Corkscrew Suture Anchors
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
510(k) Summary of Safety and Effectiveness Date Summary Prepared June 11, 2010 OCT 22 2010 Manufacturer/Distributor Arthrex, Inc. /Sponsor 1370 Creekside Boulevard Naples, FL 34108-1945 USA Courtney Smith 510(k) Contact Regulatory Affairs Project Manager Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 USA Telephone: 239/643.5553, ext. 1720 Fax: 239/598.5508 Email: Courtney.smith@arthrex.com Arthrex PushLock Anchors Trade Name Common Name Suture Anchor Product Code -MAI - Fastener, Fixation, Biodegradable, Soft Tissue Classification Name HWC - Screw, Fixation, Bone Predicate Devices K091844: Arthrex Bio-Composite Suture Tak Anchors K082810: Arthrex BioComposite Suture Anchors K061863: Arthrex PushLock, Tak and Corkscrew Suture Anchors Device Description and The Arthrex PushLock Anchors family is similar to the Intended Use predicate devices in materials and overall design. The Arthrex PushLock Anchors family is intended to be used for sutures or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, hip. Please see indications for use form for specific indications. Substantial Equivalence The Arthrex PushLock Anchors are substantially equivalent to the Arthrex BioComposite Suture Anchors and the Arthrex Summary PushLock, Tak and Corkscrew Suture Anchors predicates, in which the basic features and intended uses are the same. Any differences between the PushLock Anchors and the predicates are considered minor and do not raise questions concerning safety and effectiveness. The proposed devices are composed of Bio. BioComposite and Peek materials that are substantially equivalent to the predicate devices. The submitted mechanical testing data demonstrated that the
1
| biomechanical and mechanical testing (insertion and pull-out
strength) of the proposed devices is substantially equivalent to the
| biomechanical and mechanical testing of the predicate devices. |
|---|
| Based on the indication for use, technological characteristics, and |
| the comparison to the predicate devices, Arthrex, Inc. has |
| determined that the PushLock Anchors family is substantially |
| equivalent to currently marketed predicate devices. |
and the comments of the comments of the comments of the comments of
:
and the comments of the comments of
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
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Arthrex, Inc. % Ms. Courtney Smith Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
OCT 2 2 2010
Re: K101679
Trade/Device Name: Arthrex PushLock™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MAI, HWC Dated: October 19, 2010 Received: October 24, 2010
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. Iisting 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
3
Page 2 - Ms. Courtney Smith
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/ucm 1 15809.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/ReportalProblem/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,
Harbau Brehm
Mark N. Melkerso Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K101679: Arthrex PushLock Anchors, Additional Information, October 19, 2010
Appendix 4
Indications for Use
510(k) Number: K101679
Arthrex PushLock™ Device Name:
The Arthrex PushLock™ Anchors are intended to be used for suture (soft tissue) to bone in the shoulder, foot, ankle, knee, hand, wrist, elbow, hip, and pelvis in the following procedures:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Foot/Ankle: Repair, Repair/Tendon Hallux Valgus Reconstruction, Mid-foot Reconstruction, 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 Elbow. Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament
Reconstruction, Lateral Epicondylitis Repair
Hip: Acetabular Labral Repair.
Prescription Use __ X_AND/OR Over-The-Counter Use
(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)
(21 CFR 801 Subpart C)
PAGE 1 of 1
Jonutu fer mxn
(Division Sign Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101679