(15 days)
Not Found
No
The 510(k) summary describes a mechanical fixation device and explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks any description of training or test sets, performance studies, or key metrics typically associated with AI/ML devices.
Yes
The device is used for fixation in ligament and tendon repair, specifically for ACL repair, indicating a therapeutic purpose in treating or alleviating a condition.
No
The device description states its purpose as "fixation of bone to bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair." This indicates a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly states it is a "pre-threaded button construct," which is a physical hardware component used for fixation. There is no mention of software as the primary or sole component.
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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the Arthrex RetroButton™ is a "pre-threaded button construct" intended for "fixation of bone to bone or soft tissue to bone" and used as a "fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair." It's specifically mentioned for ACL repair.
- Mechanism of Action: This device is a physical implant used to mechanically stabilize and repair tissue. It does not analyze biological samples.
The information provided describes a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Arthrex RetroButton™ for fixation of bone to bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for Anterior Cruciate Ligament (ACL) Repair.
Product codes (comma separated list FDA assigned to the subject device)
HRS, GAT, GAP
Device Description
The Arthrex RetroButton™ is a pre-threaded button construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
Arthrex FiberWire® Button Repair Kit K031666
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
K062747 pg 1 of 1
VIII. 510(k) Summary of Safety and Effectiveness
Arthrex RetroButton™
| Manufacturer / Sponsor | Arthrex, Inc.
1370 Creekside Boulevard
Naples, Florida 34108-1945 | | | SEP 29 2000 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--|--|-------------|
| 510(k) Contact: | Ann Waterhouse, RAC
Regulatory Affairs Project Manager
Telephone: (239) 643-5553 ext. 1179
FAX: (239) 598-5508 | | | |
| Trade Name: | Arthrex RetroButton™ | | | |
| Common Name: | Plate, fixation, bone
Suture, synthetic, nonabsorbable, polyethylene
or silk | | | |
| Product Code /
Classification Name: | HRS, 21 CFR 888.3030
Plate, Fixation, bone | | | |
| | GAT, 21 CFR 878.5000
Suture, synthetic, nonabsorbable, polyethylene | | | |
| | GAP, 21 CFG 878.5030
Suture, nonabsorbable, silk | | | |
| Predicate Device: | Arthrex FiberWire® Button Repair Kit K031666 | | | |
Device Description and Intended Use:
The Arthrex RetroButton™ is a pre-threaded button construct.
The Arthrex RetroButton™ for fixation of bone to bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrey will he offering this for Anterior Cruciate Ligament (ACL) Repair.
Substantial Equivalence:
The Arthrex RetroButton™ is substantially equivalent to the predicate Arthrex FiberWire® Button Repair Kit in which the basic features and intended uses are the same. Any differences between the Arthrex RetroButton™ and the prodicate are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has deterrined that the RetroButton™ is substantially equivalent to the currently marketed predicate device.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
od and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Arthrex, Inc. % Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
SEP 29 2006
Re: K062747
============================================================================================================================================================================== Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, GAT, GAP Dated: September 13, 2006 Received: September 14, 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) rmarket 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/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 ll.
510(k) Number (if known):
510(k) Number (if known): 《062747
Device Name: Arthrex RetroButton™
Indications for Use:
The Arthrex RetroButton™ for fixation of bone to bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for Anterior Cruciate Ligament (ACL) Repair.
Prescription Use_ × (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)
Page 1 of 1 -
(Division b Division of General, Restorative, and Neurological Devices
510(k) Number IL062797
9