(42 days)
Not Found
No
The device description details a purely mechanical implant for ligament fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a Tibial Fastener intended for fixation of ligament and tendon grafts during knee reconstruction surgeries, which is a supportive mechanical function rather than a therapeutic one (i.e. treating or curing a disease/condition).
No
The device is described as an implantable fastener for ligament and tendon grafts in knee surgeries, used for fixation rather than diagnosis.
No
The device description clearly details physical components (central pin, outer sleeve, angled plate, Sizer) and mechanical testing, indicating it is a hardware medical device.
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 for diagnosis, monitoring, or screening.
- Device Description: The description clearly states the device is a "Tibial Fastener" intended for the "fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries of the knee." It's a physical implant used within the body during surgery.
- Intended Use: The intended use is for surgical fixation, not for analyzing biological samples.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Tibial Fastener is intended for use in bone fixation of ligament and tendon grafts during cruciate ligament reconstruction surgeries.
Product codes (comma separated list FDA assigned to the subject device)
MBI and JDW
Device Description
Innovasive's proposed Tibial Fastener utilizes a central pin placed inside an outer sleeve. The central pin is threaded its entire length, resembling a "screw". The pin is cannulated in a hex shape to fit a Hex Driver for insertion into the outer sleeve. The pin is designed to lock into the central ID of the outer sleeve. The outer sleeve has a threaded central ID to accept the pin component, and an angled plate designed to lay flush against the tibia and prevent the device from pulling through the tibial tunnel. The angled plate will be offered in three angles: 40°, 45°, and 50° to accommodate varying tibial tunnel angles. The outer sleeve is manually placed in the tibial tunnel, and the graft passed through the sleeve's central ID. A Sizer is used to determine the appropriate pin diameter and length by insertion into the sleeve between the graft strands. The pin is than inserted into the central ID, and locks into the sleeve. Any excess graft ends may be removed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial, 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: the ultimate holding strength of the proposed Tibial Fastener in human cadaver was compared to the predicate devices. As expected, the proposed Tibial Fastener holding strength was found to be substantially equivalent to that of the LinX Tibial Ligament Fastener, and the Soft Tissue Screw & Washer System.
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.
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
§ 888.3040 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.
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510(K) SUMMARY
1. SUBMITTER:
Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229
Contact: Kathleen Morahan, Regulatory Affairs Specialist Date Prepared: August 28, 1998
2. DEVICE:
Innovasive Tibial Fastener Classification Name: Single/multiple component bone fixation appliances and accessories.
Trade Name: Innovasive Devices Tibial Fastener
3. PREDICATE DEVICE:
The predicate devices used to determine substantial equivalence for Innovasive's Tibial Fastener are (1) the LinX Tibial Ligament Fastener, and (2) the Soft Tissue Screw & Washer System, both marketed by Innovasive Devices, Marlborough, MA.
4. DEVICE DESCRIPTION:
Innovasive's proposed Tibial Fastener utilizes a central pin placed inside an outer sleeve.
The central pin is threaded its entire length, resembling a "screw". The pin is cannulated in a hex shape to fit a Hex Driver for insertion into the outer sleeve. The pin is designed to lock into the central ID of the outer sleeve.
The outer sleeve has a threaded central ID to accept the pin component, and an angled plate designed to lay flush against the tibia and prevent the device from pulling through the tibial tunnel. The angled plate will be offered in three angles: 40°, 45°, and 50° to accommodate varying tibial tunnel angles. The outer sleeve is manually placed in the tibial tunnel, and the graft passed through the sleeve's central ID. A Sizer is used to determine the appropriate pin diameter and length by insertion into the sleeve between the graft strands. The pin is than inserted into the central ID, and locks into the sleeve. Any excess graft ends may be removed.
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The proposed Tibial Fastener outer sleeve and central pin will be offered in various sizes to accommodate varying graft and tibial tunnel sizes.
5. INTENDED USE:
The Tibial Fastener is intended for use in bone fixation of ligament and tendon grafts during cruciate ligament reconstruction surgeries.
6. COMPARISON OF CHARACTERISTICS:
The Innovasive Tibial Fastener utilizes the same basic design as the currently cleared LinX Tibial Ligament Fastener (K990491): a central pin placed inside an outer sleeve.
The proposed Tibial Fastener central pin material is identical to that of the currently cleared LinX Tibial Ligament Fastener central pin: molded Delrin (Dupont 500P or 100P NC010). The outer sleeve of the proposed Tibial Fastener is also molded from Delrin (Dupont 500P or 100P NC010). The predicate LinX Tibial Ligament Fastener outer sleeve is molded from high density polvethylene (Dow Chemical HD 8354N).
The central pin of the currently cleared device consists of a distal ribbed section designed to lock into the sleeve, and a proximal section with an eyelet to which the graft is threaded through and sutured to. The central pin of the proposed device is threaded its entire length, resembling a screw, and is cannulated in a hex shape to fit a Hex Driver that is used to insert the pin into the outer sleeve. The proposed pin will be offered in varying diameters, 6mm-11mm, and lengths, ranging from 20mm-40mm.
The existing LinX Tibial Ligament Fastener outer sleeve ID is smooth, whereas the proposed Tibial Fastener outer sleeve ID is threaded to increase the pin'sleeve interference. To accommodate different tunnel angles that are drilled per the surgeon's choice, the sleeve will be offered with an angled plate at 40° and 50°, in addition to the predicate LinX Tibial Ligament Fastener outer sleeve design of 45°. The proposed Tibial Fastener sleeve will be offered in three sizes: Small (7mm-8mm grafts), Medium (9mm-10mm grafts), and Large (11mm-12mm grafts). The predicate outer sleeve is offered in one size. The overall length of the sleeve is identical to the currently cleared LinX Tibial Ligament Fastener.
The method of graft fixation for the proposed Tibial Fastener differs from the existing LinX Tibial Ligament Fastener in that the graft is not threaded through and sutured to the pin, but threaded through the sleeve. The sleeve is manually placed in the tibial tunnel and the pin is inserted into the sleeve acting as a shim to retain the ligament. Any excess graft is removed. This method of graft fixation is identical to Innovasive's Soft Tissue Screw & Washer System (K962194), except
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this currently marketed system does not utilize a sleeve, and a Washer is used to anchor the free ends of the graft to the tibia.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
- Mechanical Testing: the ultimate holding strength of the proposed Tibial Fastener in human cadaver was compared to the predicate devices. As expected, the proposed Tibial Fastener holding strength was found to be substantially equivalent to that of the LinX Tibial Ligament Fastener, and the Soft Tissue Screw & Washer System.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 13 1998
Ms. Kathleen Morahan Regulatory Affairs Specialist Innovasive Devices, Inc. 734 Forest Street Marlborough, Massachusetts 01752
Re: K983056 Trade Name: Innovasive Tibial Fastener Regulatory Class: II Product Codes: MBI and JDW Dated: August 28, 1998 Received: September 1, 1998
Dear Ms. Morahan:
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. ਜ 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 - Ms. Kathleen Morahan
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.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
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 Tibial Fastener
The Tibial Fastener is 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)
(Division Sign-Off) Division of General Restorative Devices 12983056 510(k) Number _
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