(79 days)
the 8mm Ligament Fastener, the Soft Tissue Screw and Washer System
Not Found
No
The device description focuses on mechanical components and their function in surgical fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a fastener used to fix ligament and tendon grafts during surgical reconstruction, not to directly treat a disease or condition itself.
No
The device is described as a fastener intended for direct bone fixation of ligament and tendon grafts during cruciate ligament reconstruction surgeries. It is a mechanical implant, not a tool for diagnosis.
No
The device description clearly details physical components (central pin, outer sleeve, angled plate) made of materials intended for direct bone fixation. There is no mention of software as the primary or sole component.
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 Description and Intended Use: The LinX Tibial Ligament Fastener is a physical implant designed for direct bone fixation during surgical procedures (cruciate ligament reconstruction). It is used in the body, not to test samples from the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes.
Therefore, the LinX Tibial Ligament Fastener is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LinX Tibial Ligament Fastener is intended for use in direct bone fixation of ligament and tendon grafts during cruciate ligament reconstruction surgeries.
The LinX Tibial Ligament Fasteners are intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries of the knee.
Product codes
MBI
Device Description
The Innovasive LinX Tibial Ligament Fastener utilizes a central pin placed inside an outer sleeve resulting in direct fixation of the device into bone. The Innovasive Devices LinX Tibial Ligament Fastener will be offered in five configurations:
#1) 8mm x 40mm
#2) 8mm x 40m Short (short refers to eyelet size)
#3) 8mm x 55mm
#4) 10mm x 40mm
#5) 10mm x 55mm
The central pin has ribs along its length designed to lock into the outer sleeve as it is inserted into the sleeve inside diameter. The central pin has an eyelet through which the soft tissue graft is threaded and four through-holes located above the eyelet that may be used to suture the graft to the pin; or a pin with a short eyelet (8mm x 40mm Short) may be used, that only accepts the suture that is sutured to the graft. The front of the pin has a through-hole to accept a piece of suture to guide the pin into the sleeve during the deployment of the device. The suture is then removed and discarded.
The outer sleeve has a central ID designed to accept the pin component, and an angled plate designed to lay flush against the tibia on the outside of the knee.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
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)
Mechanical Testing: Comparison of the ultimate holding strength in human cadaver was compared to the predicate device. As expected, the Innovasive LinX Tibial Ligament Fastener holding strength was found to be substantially equivalent to the Soft Tissue Screw and Washer System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
the 8mm Ligament Fastener, the Soft Tissue Screw and Washer System
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
1980491
APR 2 9 1998
510(K) SUMMARY
1. SUBMITTER:
Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229
Contact: Stephen M. Page, Manager of Regulatory Affairs Date Prepared: February 6, 1998
2. DEVICE:
Innovasive 8mm & 10mm LinX Tibial Ligament Fastener Classification Name: Single/multiple component bone fixation appliances and accessories.
Trade Name: Innovasive Devices LinX Tibial Ligament Fastener
3. PREDICATE DEVICE:
- . The predicate devices used to determine substantial equivalence for the Innovasive Devices LinX Tibial Ligament Fastener were (1) the 8mm Ligament Fastener, and (2) the Soft Tissue Screw and Washer System, both marketed by Innovasive Devices, Marlborough, MA.
4. DEVICE DESCRIPTION:
.
The Innovasive LinX Tibial Ligament Fastener utilizes a central pin placed inside an outer sleeve resulting in direct fixation of the device into bone. The Innovasive Devices LinX Tibial Ligament Fastener will be offered in five configurations:
- #1) 8mm x 40mm #2) 8mm x 40m Short (short refers to eyelet size) #3) 8mm x 55mm #4) 10mm x 40mm #5) 10mm x 55mm
The central pin has ribs along its length designed to lock into the outer sleeve as it is inserted into the sleeve inside diameter. The central pin has an eyelet through which the soft tissue graft is threaded and four through-holes located above the eyelet that may be used to suture the graft to the pin; or a pin with a short eyelet (8mm x 40mm Short) may be used, that only accepts the suture that is sutured to
1
the graft. The front of the pin has a through-hole to accept a piece of suture to guide the pin into the sleeve during the deployment of the device. The suture is then removed and discarded.
The outer sleeve has a central ID designed to accept the pin component, and an angled plate designed to lay flush against the tibia on the outside of the knee.
5. INTENDED USE:
The LinX Tibial Ligament Fastener is intended for use in direct bone fixation of ligament and tendon grafts during cruciate ligament reconstruction surgeries.
6. COMPARISON OF CHARACTERISTICS:
The Innovasive LinX Tibial Ligament Fastener utilizes the same basic design as the currently marketed 8mm Ligament Fastener (K970316). This design utilizes a central pin placed inside an outer sleeve resulting in the ultimate fixation of the device into bone.
The central pin of the proposed device differs from the currently marketed central pin only in evelet size, overall length and the presence of four-through holes located above the evelet that may be used to suture the free ends of the soft tissue graft to the pin.
The outer sleeve of the proposed device has a smooth exterior and an angled plate that lays flush against the tibia on the outside of the knee. The angled plate provides the ultimate device fixation since it prevents the device from pulling through the tibial tunnel. The currently marketed outer sleeve has a threaded exterior that is threaded into a tapped bone hole providing the ultimate fixation of the device.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
- Mechanical Testing: Comparison of the ultimate holding strength in human cadaver was compared to the predicate device. As expected, the Innovasive LinX Tibial Ligament Fastener holding strength was found to be substantially equivalent to the Soft Tissue Screw and Washer System.
BOxEBO
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1998
Mr. Stephen M. Page Manager, Regulatory Affairs Innovasive Devices, Inc. 734 Forest Street Marlborough, Massachusetts 01752
K980491 Re: Innovasive LinX Tibial Liqament Fastener Trade Name: Requlatory Class: II Product Code: MBI February 6, 1998 Dated: February 9, 1998 Received:
Dear Mr. Page:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ਮੁ substantially equivalent, determination assumes compliance with ______________________________________________________________________________________________________________ the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Stephen M. Page
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Whitton, Ph.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE LinX Tibial Ligament Fastener
The LinX Tibial Ligament Fasteners are intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries of the knee.
Prescription Use
(Per 21 CFR 801.109)
Sign-Off) (Division (Division of General Restorative Devicess
Division of General Restorative Devices પ્રવ મધુર 510(k) Number .
30208