(79 days)
Not Found
No
The summary describes a mechanical implant for bone fixation and does not mention any software, image processing, or AI/ML terms.
Yes
The device is used for fixation of tissue during cruciate ligament reconstruction procedures, which is a therapeutic intervention.
No
The Intended Use/Indications for Use states the device is for "fixation of tissue including ligament or tendon to bone and bone tendon during cruciate ligament reconstruction procedures," which describes a surgical fixation device, not a diagnostic one.
No
The device description explicitly states it consists of a "pre-packaged mating sheath and a screw pair," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of tissue including ligament or tendon to bone and bone tendon during cruciate ligament reconstruction procedures." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is described as a "pre-packaged mating sheath and a screw pair." This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during cruciate ligament reconstruction procedures.
Product codes
HWC, MBI
Device Description
The Arthrex Tibial GraftBolt consists of a pre-packaged mating sheath and a screw pair offered in two new sizes which extend the current size range.
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
The submitted mechanical testing data demonstrated that the ultimate load strength of the proposed devices meets or exceeds the minimum acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
K093912: Arthrex Tibial GraftBolt
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
Arthrex SPECIAL 510(k): Arthrex GraftBolt
4 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | October 13, 2010 |
|---|---|
| Manufacturer/Distributor | |
| /Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Regulatory Affairs Project Manager | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1720 | |
| Fax: 239/598.5508 | |
| Email: csmith@arthrex.com | |
| Trade Name | Arthrex Tibial GraftBolt |
| Common Name | Screw, Fixation, Bone |
| Product Code - | |
| Classification Name | HWC - Screw, fixation, bone |
| Predicate Devices | K093912: Arthrex Tibial GraftBolt |
| Device Description and | |
| Intended Use | The Arthrex Tibial GraftBolt consists of a pre-packaged mating |
| sheath and a screw pair offered in two new sizes which extend | |
| the current size range. | |
| The Arthrex Tibial GraftBolt is intended to be used for fixation | |
| of tissue including ligament or tendon to bone and bone tendon | |
| during cruciate ligament reconstruction procedures. | |
| Substantial Equivalence | |
| Summary | The Arthrex Tibial GraftBolt is substantially equivalent to the |
| Arthrex Tibial GraftBolt (K093912), in which the basic features, | |
| materials and intended uses are the same. Any differences | |
| between the Tibial GraftBolt and the predicate are considered | |
| minor and do not raise questions concerning safety and | |
| effectiveness. | |
| The submitted mechanical testing data demonstrated that the | |
| ultimate load strength of the proposed devices meets or exceeds | |
| the minimum acceptance criteria. | |
| Based on the indication for use, technological characteristics, and | |
| the comparison to the predicate devices, Arthrex, Inc. has | |
| determined that the Arthrex Tibial GraftBolt is substantially | |
| equivalent to currently marketed predicate devices. |
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines representing its body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 5 2011
Arthrex. Inc. c/o Ms. Courtney Smith Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K103060
Trade/Device Name: Arthrex Tibial GraftBolt Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 19, 2010 Received: December 22, 2010
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. 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 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
2
Page 2 - Ms. Courtney Smith
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/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,
erely yours,
N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Arthrex SPECIAL 510(k): Arthrex GraftBolt
3 Indications for Use Form
Indications for Use
510(k) Number:
KI03060
Device Name:
Arthrex Tibial GraftBolt
Indications For Use:
The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during cruciate ligament reconstruction procedures
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. Melkerson
(Division Sign-Oft)
Division of Surgical, Orthopedic,
Restorative Devices
Division of Surgical, of Surgical, of Surgices
and Restorative Devices
and Restorative Devices and Restorative and
510(k) Number