(26 days)
Not Found
No
The device description and intended use are purely mechanical, describing a suture anchor for tissue fixation. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
Yes.
The device, a suture anchor, is intended for suture or tissue fixation in various parts of the body to stabilize and repair ligaments and tendons, which directly contributes to the restoration of normal function and health, thus serving a therapeutic purpose.
No
The device description clearly states it is a "suture anchor" intended for "suture or tissue fixation," which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a "suture anchor," which is a physical implantable device, not software.
Based on the provided information, the Arthrex PushLock™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Arthrex PushLock™ Function: The description clearly states that the Arthrex PushLock™ is a "suture anchor" used for "suture or tissue fixation" in various anatomical locations. It is a physical implant used to secure tissues or sutures within the body during surgical procedures.
- Lack of Specimen Examination: There is no mention of the device being used to collect, prepare, or examine any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, the Arthrex PushLock™ falls under the category of a surgical implant or device used for fixation, not an IVD.
N/A
Intended Use / Indications for Use
The Arthrex PushLock™ is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below:
Stabilization and fixation of oral cranio-maxillofacial skeletal bone, Skull: mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull
Biceps Tendon Reattachment. Ulnar or Radial Collateral Ligament Elbow: Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI, MAI
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
foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below:
Stabilization and fixation of oral cranio-maxillofacial skeletal bone, Skull: mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull
Elbow
Shoulder
Hand/Wrist
Foot/Ankle
Knee
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)
Not Found
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.
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
§ 888.3040 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.
0
Ko63479 page '14
VIII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
ARTHREX 2.5 MM PUSHLOCK™
DEC 1 3 2006
| Manufacturer / Sponsor | Arthrex, Inc.
1370 Creekside Boulevard
Naples, Florida 34108-1945 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Contact | Ann Waterhouse, RAC
Regulatory Affairs Project Manager
Telephone: (239) 643-5553 ext. 1179
FAX: (239) 598-5539 |
| Trade Name | PushLock™ |
| Common Name | Fastener; Screw, Fixation, Bone |
| Product Code/Classification Name | 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 | Tak Family Suture Anchors: K050749 |
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 to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications.
Substantial Equivalence Summary
The Arthrex PushLock™ (suture anchor) is substantially equivalent to the predicate Arthrex Tak Family in which the basic features and intended uses are the same. Any differences between the PushLock™ (suture anchor) and the predicate Tak Family 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 anchor) is substantially equivalent to the currently marketed predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS). The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arthrex, Inc. % Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
DEC 1 3 2006
Re: K063479
Trade/Device Name: Arthrex 2.5mm PushLock™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, MAI Dated: November 16, 2006 Received: November 22, 2006
Dear Ms. Waterhouse:
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.
2
Page 2 - Ms. Ann Waterhouse, 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" (21 CFR 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
3
Indications for Use Form ==============================================================================================================================================================================
510(k) Number (if known): K063479
Device Name: Arthrex 2.5 mm PushLock™
Indications for Use:
The Arthrex PushLock™ is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below:
Stabilization and fixation of oral cranio-maxillofacial skeletal bone, Skull: mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull
Biceps Tendon Reattachment. Ulnar or Radial Collateral Ligament Elbow: Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Prescription Use X AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) Company of Children Comments (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
============================================================================================================================================================================== The Collection, Office of Device Evaluation (ODE) (NUND)
ion-( ) if Division of General, Restorative, and Newslogical Devices
Page 1 of __1
510(k) Number Ko63479