(117 days)
Not Found
No
The device description and performance studies focus on mechanical properties and fixation, with no mention of AI or ML.
No.
This device is an orthopedic fastener used for fixation of grafts in ligament and tendon repair, which is a supportive function rather than a therapeutic one that directly treats a disease or condition.
No
The device description indicates it is a surgical fastener used for fixing ligaments and tendons in knee reconstruction, not for diagnosis.
No
The device description clearly details a physical implantable device (ligament fastener) made of hardware components (pin, sleeve, side-plate, pegs). There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description clearly states that this device is a surgical implant used for the fixation of ligament and tendon bone block grafts during cruciate ligament reconstruction surgeries of the knee. This is a procedure performed directly on the patient's body, not on specimens taken from the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.
This device is a surgical implant/instrument used in a surgical procedure.
N/A
Intended Use / Indications for Use
The 10mm Ligament Fasteners are intended for use in the fixation of ligament and tendon bone block grafts in cruciate ligament reconstruction surgeries of the knee.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HRX, and HWC
Device Description
The Innovasive 10mm Ligament Fastener utilizes a central pin placed inside an outer sleeve resulting in the expansion of the outer sleeve and the ultimate fixation of the device into bone. The Innovasive Devices 10mm Ligament Fastener will be offered in a single size, 10mm outside diameter and 20mm long.
The outer sleeve has threads on its exterior to hold to the bone and a central ID designed to accept the pin component.
The central pin has ribs along its length designed to expand the outer sleeve as it is placed down the sleeve inside diameter. In addition, the central pin incorporates a "side-plate" with two transverse pegs to hold a bone plug for bone-patella-bone fixation of the soft tissue 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.
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 a bone model compared to the predicate device. The Innovasive 10mm Ligament Fastener holding strength was found to be equivalent to the strength of the predicate device.
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.
Not Found
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.
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.
0
Image /page/0/Picture/1 description: The image shows the text "K974049" on the top line and "510(K) SUMMARY" on the second line. The text is black and the background is white. The text appears to be handwritten or in a font that mimics handwriting.
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: October 22, 1997
2. DEVICE:
ుండి 10:5
Innovasive 10mm Ligament Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: innovasive Devices 10mm Ligament Fastener
3. PREDICATE DEVICE:
The predicate devices used to determine substantial equivalence for the Innovasive Devices 10mm Ligament Fastener were (1) the 8mm Innovasive Devices Ligament Fastener marketed by Innovasive Devices, Marlborough, MA, and (2) the Mitek Ligament Anchor marketed by Mitek Surgical, Norwood, MA.
4. DEVICE DESCRIPTION:
The Innovasive 10mm Ligament Fastener utilizes a central pin placed inside an outer sleeve resulting in the expansion of the outer sleeve and the ultimate fixation of the device into bone. The Innovasive Devices 10mm Ligament Fastener will be offered in a single size, 10mm outside diameter and 20mm long.
The outer sleeve has threads on its exterior to hold to the bone and a central ID designed to accept the pin component.
The central pin has ribs along its length designed to expand the outer sleeve as it is placed down the sleeve inside diameter. In addition, the central pin incorporates a "side-plate" with two transverse pegs to hold a bone plug for bone-patella-bone fixation of the soft tissue 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.
1
5. INTENDED USE:
The 10mm Ligament Fasteners are intended for use in the fixation of ligament and tendon bone block grafts in cruciate ligament reconstruction surgeries of the knee.
6. COMPARISON OF CHARACTERISTICS:
The Innovasive 10mm Ligament Fastener utilizes the same basic design for fixation into bone as the currently marketed 8mm Ligament Fastener (K970316). This design utilizes a central pin placed inside an outer sleeve resulting in the expansion of the outer sleeve and the ultimate fixation of the device into bone.
The outer sleeve is identical for both the 8mm and 10mm Ligament Fasteners. However, the central pin for the existing 8mm Ligament Fastener has a radius at the eyelet designed for direct fixation of the soft tissue graft; whereas the central pin for the proposed 10mm Ligament Fastener incorporates a "side-plate" with two transverse pegs to hold a bone plug for bone-patella-bone fixation of the soft tissue graft.
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 a bone model compared to the predicate device. The Innovasive 10mm Ligament Fastener holding strength was found to be equivalent to the strength of the predicate device.
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Image /page/2/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 image of an eagle or bird in flight, composed of three curved lines. The bird is oriented towards the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen M. Page Manager of Regulatory Affairs Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts
FEB | 8 1998
K974049 Re : LinX BT 10mm Ligament Fastener Trade Name: Regulatory Class: II Product Codes: MBI, HRX, and HWC Dated: January 23, 1998 Received: January 26, 1998
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 The general controls provisions of the Act 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. A substantially equivalent determination assumes compliance with ---the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. 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 requlations.
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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.qov/cdrh/dsmamain.html".
Sincerely yours,
a 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 10mm Ligament Fastener
The 10mm Ligament Fasteners are intended for use in the fixation of ligament and tendon bone block grafts in cruciate ligament reconstruction surgeries of the knee.
Prescription Use
(Per 21 CFR 801.109)
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Sion-Off Divis Division of General Restorative De 974049 510(k) Numb