(103 days)
No
The device description and intended use clearly define a mechanical suture anchor. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML.
No
The device is described as a suture anchor for tissue fixation, used in surgical repairs of ligaments and tendons, which functions as a structural support rather than providing therapeutic action itself.
No
The device is described as an implantable suture anchor used for tissue fixation and repair, not for diagnosing medical conditions. Its intended use details surgical procedures it assists with, not diagnostic evaluations.
No
The device description clearly states it is a two-piece "push-in" suture anchor device comprising a biodegradable anchor body and a PEEK eyelet, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for "suture or tissue fixation" in various anatomical locations (foot, ankle, knee, etc.). This is a surgical/implantable device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a "two piece 'push-in' suture anchor device" made of biodegradable materials with a PEEK eyelet. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information.
Therefore, this device falls under the category of a surgical implant or fixation device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The 2.5mm Arthrex Mini Bio-PushLock is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
The 2.9mm BioComposite PushLock is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Bicens Tendon Reattachment, Tennis Elbow Repair.Unar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
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, Ulnar or Radial Collateral Ligament Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral repair
Product codes
MAI
Device Description
The Arthrex PushLock is a two piece "push-in" suture anchor device comprising a biodegradable anchor body manufactured from either PLLA or PLDLA/βTCP with a polyetheretherketone (PEEK) eyelet pre-loaded on a disposable inserter. The anchor body ranges in diameter from 2.5mm to 2.9mm and 8mm to 15.5mm in length.
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 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)
Inherent viscosity and minimum peak load testing was performed after four years on the shelf to support the shelf-life expansion to four years. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
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
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
January 16, 2018
Arthrex Inc. David L. Rogers Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K173240
Trade/Device Name: Arthrex PushLock Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: July 21, 2017 Received: October 18, 2017
Dear Mr. Rogers:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K173240
Device Name Arthrex PushLock
Indications for Use (Describe)
The 2.5mm Arthrex Mini Bio-PushLock is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
The 2.9mm BioComposite PushLock is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Bicens Tendon Reattachment, Tennis Elbow Repair.Unar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
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, Ulnar or Radial Collateral Ligament Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral repair
Type of Use (Select one or both, as applicable)
- | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
| Date Prepared | July 21, 2017 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | David L Rogers |
| Project Manager, Regulatory Affairs | |
| 1-239-643-5553, ext. 71924 | |
| david.rogers@arthrex.com | |
| Name of Device | Arthrex PushLock |
| Common Name | Suture Anchor |
| Product Code | MAI |
| Classification Name | 21 CFR 888.3030: Fastener, Fixation, Biodegradable, Soft Tissue |
| Regulatory Class | = |
| Predicate Device | K063479: Arthrex PushLock |
| K101679: Arthrex PushLock | |
| Purpose of | This traditional 510(k) premarket notification is submitted to expand the shelf-life |
| Submission | for the bioabsorbable Arthrex PushLocks cleared under K063479 and K101679 |
| from 2 years to 4 years. | |
| Device Description | The Arthrex PushLock is a two piece "push-in" suture anchor device comprising a |
| biodegradable anchor body manufactured from either PLLA or PLDLA/βTCP with | |
| a polyetheretherketone (PEEK) eyelet pre-loaded on a disposable inserter. The | |
| anchor body ranges in diameter from 2.5mm to 2.9mm and 8mm to 15.5mm in | |
| length. | |
| Indications for Use | The 2.5mm Arthrex PushLock is intended to be used for suture or tissue fixation |
| in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific | |
| indications are listed below: | |
| Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament | |
| ● | |
| Reconstruction | |
| Shoulder: Rotator Cuff Repairs, 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 | |
| ● | |
| Reconstructions, 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 | |
| The 2.9mm Arthrex Knotless SutureTak Anchor is intended to be used for suture | |
| or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. | |
| Specific indications are listed below: | |
| Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or | |
| Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, | |
| Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, | |
| Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial | |
| Collateral Ligament Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon | |
| Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital | |
| Tendon Transfers, Mid-foot Reconstruction, Bunionectomy Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament | |
| Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, | |
| Iliotibial Band Tenodesis Hip: Capsular Repair, Acetabular Labral repair | |
| Performance Data | Inherent viscosity and minimum peak load testing was performed after four years |
| on the shelf to support the shelf-life expansion to four years. |
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that
the device meets pyrogen limit specifications. |
| Conclusion | The Arthrex PushLock is substantially equivalent to the predicate devices in which
the basic design features and intended uses are the same. The subject devices
have already been FDA cleared under predicates K063479 and K101679. The only
modification presented in this submission is the expansion of the device shelf-life
from two years to four years. Any differences between the proposed device and
the predicate device are considered minor and do not raise questions concerning
safety or effectiveness.
Based on the indications for use, technological characteristics, and the summary
of data submitted, Arthrex Inc. has determined that the proposed device is
substantially equivalent to the currently marketed predicate device. |
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