(107 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation strength of a physical implant and its associated instruments, with no mention of AI or ML technologies.
No
The device is described as an intratunnel implant intended to aid in fixation during ACL/PCL reconstruction, not to treat a disease or condition in a therapeutic manner beyond providing mechanical support during a surgical procedure.
No
The device is described as an intratunnel implant used for fixation of soft-tissue grafts in ACL/PCL reconstruction, not for diagnosis.
No
The device description clearly states it is a "non-resorbable intratunnel implant" and includes "an inserter instrument" and a "nitinol quide wire instrument," indicating it is a physical medical device with hardware components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is an "intratunnel implant intended to aid in arthroscopic ACL and/or PCL reconstructions." It's a physical device used within the body to fix soft tissue grafts.
- Intended Use: The intended use is to "provide fixation of soft-tissue grafts within the tibial tunnel." This is a surgical procedure, not a diagnostic test performed on a sample.
- No Mention of Samples or Testing: The description focuses on the mechanical function of the device for fixation and the instruments used for insertion. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, the Biomet Sports Medicine TunneLoc™ Tibial Fixation Device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TunneLoc™ Tibial Fixation Device is intended for soft tissue fixation for the following indications:
To provide fixation of soft-tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
Product codes
MBI, HWC
Device Description
The Biomet Sports Medicine TunneLoc™ Tibial Fixation Device is a non-resorbable intratunnel implant intended to aid in arthroscopic ACL and/or PCL reconstructions. The inserter instrument provides a means to apply and hold tension to the soft tissue, align and drive the PEEK implant. A nitinol quide wire instrument is provided to aid in implant placement. The TunneLoc™ Tibial Fixation Devices provide the surgeon with a means to aid in the management of soft tissue to bone reattachment procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial tunnel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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
Non-Clinical Testing:
Non-clinical laboratory testing was performed to verify the fixation strength of the TunneLoc™ Tibial Fixation Devices in pullout tests using porcine tibia and bovine tendon test medium as compared to the predicate devices for specific indications for use. The test results indicate that the TunneLoc™ Tibial Fixation Devices provide equivalent pullout strength to the predicate devices and would be functional within their intended use.
Clinical Testing:
None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K041274, K982497, K083607, K983560
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
Image /page/0/Picture/1 description: The image shows the logo for Biomet Sports Medicine. The logo consists of the word "BIOMET" in a bold, blocky font, with a small registered trademark symbol to the right of the "T". Below the word "BIOMET" is the phrase "SPORTS MEDICINE" in a smaller, sans-serif font.
FEB - 9 2011
510(k) Summary
| Preparation Date: | February 9, 2010 |
|---|---|
| Applicant/Sponsor: | Biomet Sports Medicine |
| Contact Person: | Robert R. Friddle |
| Regulatory Affairs Specialist | |
| Proprietary Name: | TunneLoc™ Tibial Fixation Device |
| Common Name: | Soft tissue fixation device |
| Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue (21CFR |
| §888.3040) MBI | |
| Screw, Fixation, Bone (21CFR §888.3040) HWC |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| K041274 | Resorbable Interference Screw |
|---|---|
| K982497 | Arthrotek Interference Screw |
| K083607 | AperFix™ Tibial Implant with Inserter |
| K983560 | Intratunnel Tibial Fixation Fastener |
Device Description:
The Biomet Sports Medicine TunneLoc™ Tibial Fixation Device is a non-resorbable intratunnel implant intended to aid in arthroscopic ACL and/or PCL reconstructions. The inserter instrument provides a means to apply and hold tension to the soft tissue, align and drive the PEEK implant. A nitinol quide wire instrument is provided to aid in implant placement. The TunneLoc™ Tibial Fixation Devices provide the surgeon with a means to aid in the management of soft tissue to bone reattachment procedures.
Intended Use:
The TunneLoc™ Tibial Fixation Device is intended for soft tissue fixation for the following indications:
To provide fixation of soft-tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800.348.9500
Office: 574.267.6639
Main Fax: 574.267.8137
www.biomet.com
Shipping Address:
56 East Bell Drive
Warsaw, IN 46582
1
K103145(²/₂)
Summary of Technologies:
The TunneLoc™ Implant design includes technological characteristics and indications similar or identical to the predicate devices. The conical shell with blunt wedge tip is similar to the tapered sheath of the predicate Intratunnel Tibial Fixation Fastener (K983560), while the cannulation and insertion over a quide wire are similar to the predicate Gentle Threads™ (K041274). The TunneLoc™ implant is composed of PEEK material like the predicate AperFix™ (K083607). Dimensional characteristics of a 7-10mm diameter range is available in the predicate Gentle Threads™ (K041274) and 30mm length available in all predicates. The TunneLoc™ inserter instrument provides a means to apply and hold tension to the soft tissue graft prior to and during implant insertion similar to the predicate Intratunnel Tibial Fixation Fastener (K983560) and AperFix™ (K083607) Instruments.
Non-Clinical Testing:
Non-clinical laboratory testing was performed to verify the fixation strength of the TunneLoc™ Tibial Fixation Devices in pullout tests using porcine tibia and bovine tendon test medium as compared to the predicate devices for specific indications for use. The test results indicate that the TunneLoc™ Tibial Fixation Devices provide equivalent pullout strength to the predicate devices and would be functional within their intended use.
Clinical Testing:
None provided as a basis for substantial equivalence.
All trademarks are the property of Biomet, Inc. except AperFix™ which is a trademark of Cayenne Medical, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake coiled around it, and three lines extending from the top of the staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Biomet Sports Medicine % Mr. Robert Friddle Regulatory Specialist 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
FEB 0 9 2011
Re: K103145
Trade/Device Name: TunneLoc™ Tibial Fixation Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: February 4, 2011 Received: February 7, 2011
Dear Mr. Friddle:
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
3
device-related adverse events) (21 CFR 803); 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/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/ReportaProblem/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.
Ating B. Rata
for
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): كل 103146)5
Device Name: TunneLoc™ Tibial Fixation Device
Indications For Use:
To provide fixation of soft-tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ NO (21 CFR 807 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 Sign-Off)
for M.Mellors
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103145