(66 days)
No
The summary describes a mechanical implant (graft-anchor) and its intended uses and mechanical performance, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used for suture or tissue fixation to repair and reconstruct various ligaments and tendons, which directly addresses medical conditions to restore function.
No
The device is described as an Arthrex Graft-Anchor intended for suture or tissue fixation, functioning as a "push-in" anchor. Its purpose is to repair or reconstruct anatomical structures, indicating a surgical, therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a "one-piece titanium 'push-in' anchor," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a graft-anchor) used for fixing sutures or tissue within the body during surgical procedures. It is used directly on the patient's anatomy, not on specimens taken from the patient.
The description focuses on the mechanical properties and surgical applications of the device, which are characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Arthrex Graft-Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament 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, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
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
MBI, HWC
Device Description
The Arthrex Graft-Anchor is a one-piece titanium “push-in” anchor and comes pre-loaded on a driver.
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, and shoulder
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 mechanical testing demonstrates that the pull-out strength of the proposed devices meets or exceeds the pull-out strength of the predicate device.
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
§ 888.3040 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
AUG 1 9 2011
Arthrex SPECIAL 510(k): Arthrex Scapholunate Anchor
2 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | June 9, 2011 |
|---|---|
| Manufacturer/Distributor | |
| /Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Manager, Regulatory Affairs | |
| 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 | |
| Trade Name | Graft-Anchor |
| Common Name | Screw, Fixation, Bone |
| Product Code - | |
| Classification Name | HWC – Screw, fixation, bone |
| MBI – Fastener, fixation, nondegradable, soft tissue | |
| 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories. | |
| 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | |
| Predicate Devices | K063479: Arthrex Mini PushLock |
| Device Description and | |
| Intended Use | The Arthrex Graft-Anchor is a one-piece titanium “push-in” anchor and comes pre-loaded on a driver. |
| The Arthrex Graft-Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. | |
| Substantial Equivalence | |
| Summary | The Arthrex Graft-Anchor is substantially equivalent to the Arthrex Mini PushLock predicate, in which the basic features, and intended uses are the same. Any differences between the Graft-Anchor and the predicate are considered minor and do not raise questions concerning safety and effectiveness. |
| The mechanical testing demonstrates that the pull-out strength of the proposed devices meets or exceeds the pull-out strength of the predicate device. Based on the indication for use, technological characteristics, and the comparison to the predicate device, Arthrex, Inc. has determined that the Arthrex Graft-Anchor is substantially equivalent to currently marketed predicate device. |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that converge at the top and then separate into three distinct shapes at the bottom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring MD 20993-0002
Arthrex, Inc. % Ms. Courtney Smith Manager Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
AUG 1 9 2011
Re: K111661
Trade/Device Name: Arthrex Graft-Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: August 3, 2011 Received: August 4, 2011
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, 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 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
2
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/AboutfiDA/CentersOffices/CDRHOffices/ucm115809.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,
E. M. Keith
- So Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
1 Indications for Use Form
Indications for Use
510(k) Number:
Device Name:
K11661 Arthrex Graft-Anchor
Indications For Use:
Indications for Use:
The Arthrex Graft-Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
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, Repair/Reconstruction of
collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP,
DIP and MCP joints for all digits, digital tendon transfers, Carpal
Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal
thumb joint arthroplasty) |
| 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)
(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. Malkerson
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111661