(173 days)
Not Found
No
The summary describes a mechanical fixation device (buttons and suture) and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as a "fixation post, a distribution bridge, or for distributing suture tension" for ligament or tendon repair, specifically ACL repair. While it assists in repair, it does not directly treat a disease or condition in the body, but rather provides mechanical support for surgical reconstruction.
No
The device is described as a kit for fixation of bone to bone or soft tissue to bone, specifically for ACL repair, and consists of metal buttons. Its function is to provide mechanical support rather than to diagnose medical conditions or provide information for diagnosis.
No
The device description explicitly states it consists of "metal buttons" made of "Titanium 6AL4V ELI," which are hardware components.
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 device is a "Button Kit for fixation of bone to bone or soft tissue to bone" and is used for "ACL repair." This involves direct surgical implantation and fixation within the body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
This device is a surgical implant used for mechanical fixation during a surgical procedure, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Arthrex ACL RetroConstruction™ Button Kit for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons and recommending use of size 2 or size 5 FiberWire™ or equivalent. Specifically, Arthrex will be offering this for ACL repair.
Product codes
HRS, GAT
Device Description
Arthrex, Inc. ACL RetroConstruction™ Button Kit consists of metal buttons. These buttons are Titanium 6AL4V ELI and have either 2 or 4 holes for inclusion of suture. The suture recommended for use with this kit is FiberWire™, an Arthrex product, which is offered in various sizes and configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, ligament, tendon, ACL
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)
K010673, K012923, K021434, K980155, K022853, K990120, K982347, K990156
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
NOV 1 8 2003
K031666
page 1 of 1
510(k) Summary
| 510(k) Number: | K031666 |
|---|---|
| Contact Person: | Ann Waterhouse, Regulatory Affairs Specialist |
| Date Prepared: | June 2003 |
| Trade/Proprietary Name: | Arthrex ACL RetroConstruction™ Button Kit |
| Product Code: | HRS |
| Classification Name: | Plate, Fixation, Bone |
| Predicate Devices: | Arthrex K010673, Arthrex K012923, Arthrex K021434, |
| Smith & Nephew K980155, Karl Storz Endoscopy- | |
| America, Inc. K022853, DePuy ACE K990120, DePuy | |
| ACE K982347, and Bonutti Research K990156. |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Intended Use:
The Arthrex ACL RetroConstruction™ Button Kit for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons and recommending use of size 2 or size 5 FiberWire™ or equivalent. Specifically, Arthrex will be offering this for ACL repair.
Description:
Arthrex, Inc. ACL RetroConstruction™ Button Kit consists of metal buttons. These buttons are Titanium 6AL4V ELI and have either 2 or 4 holes for inclusion of suture. The suture recommended for use with this kit is FiberWire™, an Arthrex product, which is offered in various sizes and configurations.
Substantial Equivalence:
The Arthrex, Inc. ACL RetroConstruction ™ Button kit is substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Arthrex device and predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
NOV 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re: K031666 Trade/Device Name: Arthrex Fiberwire™ Button Repair Kit Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS, GAT Dated: September 25, 2003 Received: September 26, 2003
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
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 (301) 594- 4659. 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known):
Device Name: Arthrex Fiberwire™ Button Repair Kit
Indications for Use:
The Arthrex ACL RetroConstruction™ Button Kit for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons and recommending use of size 2 or size 5 FiberWire™ or equivalent. Specifically, Arthrex will be offering this for ACL repair.
(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Option Format 3-10-98)
Mark n Millen
Division Six of
25 orative (k) Number _____