(48 days)
Not Found
No
The description focuses on a mechanical suture anchor and its intended surgical uses, with no mention of AI or ML.
No
A therapeutic device is one that performs a treatment or cures a disease. This device is used to fix suture to bone for reconstruction and repair, which places it as a surgical aid rather than a therapeutic device that directly treats or cures a condition.
No
The device description and intended use clearly state that the Arthrex PushLock™ is a "suture anchor" intended for "fixation of suture to bone" in various repair and reconstruction procedures. It is a surgical implant designed to facilitate healing, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a "suture anchor," which is a physical implantable medical device, not software.
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 about a person's health. They are used outside of the body.
- Arthrex PushLock™ Function: The Arthrex PushLock™ is a surgical implant (a suture anchor) used to fix suture to bone within the body during surgical procedures. It is a physical device used for mechanical fixation, not for analyzing biological samples.
The provided information clearly describes a surgical implant used for orthopedic and pelvic procedures, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Arthrex PushLock™ is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, 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
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
- 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction
- Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
Product codes
MAI, MBI, HWC
Device Description
The Arthrex PushLock™ (suture anchor) is a 2 piece "push-in" anchor. The suture anchor is designed to use the principles of compression to force the eyelet, threaded with appropriate suture, into a predrilled hole.
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 pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
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
JUN 2 9 2005
IX. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
ARTHREX PUSHLOCK ™
| MANUFACTURER / SPONSOR | Arthrex, Inc.
1370 Creekside Boulevard
Naples, Florida 34108-1945 |
|------------------------|----------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Sally Foust, RAC
Sr. Regulatory Affairs Specialist
Telephone: (239) 643-5553 ext. 1251 |
TRADE NAME:
PushLock™
FAX: (239) 598-5539
COMMON NAME: PRODUCT CODE / CLASSIFICATION NAME
Fastener; Screw, Fixation, Bone
HWC/MBI 21 CFR 888,3040 Fastener, Fixation, Nondegradable, Soft Tissue Smooth or threaded metallic bone fixation fastener MAI/ 21 CFR 888.3030 Fastener, Fixation, Biodegradable, Soft Tissue
PREDICATE DEVICE:
Bio-FASTak Suture Anchors: K971723 & K000506
DEVICE DESCRIPTION AND INTENDED USE:
The Arthrex PushLock™ (suture anchor) is a 2 piece "push-in" anchor. The suture anchor is designed to use the principles of compression to force the eyelet, threaded with appropriate suture, into a predrilled hole.
The Arthrex PushLock™ is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis.
SUBSTANTIAL EQUIVALENCE SUMMARY
The Arthrex PushLock™ (suture anchor) is substantially equivalent to the predicate Arthrex Bio-FASTak Suture Anchor in which the basic features and intended uses are the same. Any differences between the PushLock™ (suture anchor) and the predicate Bio-FASTak Anchor are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the new PushLock™ (suture andhor) is substantially equivalent to the currently marketed predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight.
Public Health Service
JUN 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sally Foust, RAC Senior Regulatory Affairs Specialist Arthrex Incorporated 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K051219 Trade/Device Name: Arthrex PushLock™ Regulation Number: 21 CFR 888.3040, 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener, Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI, MBI, HWC Dated: June 10, 2005 Received: June 13, 2005
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 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Sally Foust, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stupt Rudu
Miriam C. Provost, Ph.D.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE FORM 111.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Arthrex PushLock™
Indications for Use:
The Arthrex PushLock™ is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, 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
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
- 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction
- Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801 Subpart D) | |
| AND/OR Over-The-Counter Use | |
| (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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| Page 1 of 1 | |
|---|---|
| 510(k) Number | K051219 |
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