(139 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of a biodegradable screw, with no mention of AI or ML.
No
The device is described as an interference screw used for fixation of soft tissue or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries. Its primary function is mechanical support and fixation, not direct treatment or alleviation of a disease or condition for therapeutic purposes.
No
Explanation: The device is an implantable screw used for fixation of grafts during surgery, not for diagnosing medical conditions. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly states it is a "biodegradable interference screw," which is a physical implantable device, not software.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly states that the Bio-Interference Screw is intended for the fixation of grafts during knee surgery. It is a physical implant used within the body, not a device used to analyze samples outside the body.
The description focuses on its mechanical function in surgery, not on diagnostic testing.
N/A
Intended Use / Indications for Use
The proposed Bio-Interference Screw is intended for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
Product codes
HWC
Device Description
The Bio-Interference Screw is a biodegradable interference screw intended for interference fit fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. The device is offered in varying diameters and lengths.
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
Bone Model Testing: the ultimate holding strength of the proposed Bio-Interference Screw was compared to the currently marketed Arthrex Bio-Interference Screw. The testing demonstrates substantially equivalent performance between the two devices.
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo for Innovasive Devices. The logo includes two triangles stacked on top of each other, with the text "INNOVASIVE" in bold letters and "DEVICES" in smaller letters underneath. Above the logo, the text "JUL - 1 1999" is printed.
K990454 510(K) SUMMARY
1. SUBMITTER:
Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229 Fax: 508-460-6661
Contact: Kathleen Morahan, Regulatory Affairs Specialist Date Prepared: February 11, 1999
2. DEVICE:
Trade Name: Innovasive Bio-Interference Screw
Common Name: Interference Screw
Classification Name: Not Classified
3. PREDICATE DEVICE:
(1) Arthrex Bio-Interference Screw - K971358
4. DEVICE DESCRIPTION:
The Bio-Interference Screw is a biodegradable interference screw intended for interference fit fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. The device is offered in varying diameters and lengths.
5. INTENDED USE:
The proposed Bio-Interference Screw is intended for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
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6. COMPARISON OF CHARACTERISTICS:
The design of Innovasive's proposed Bio-Interference Screw is very similar to the predicate device: both devices are cannulated, threaded, tapered, and are offered in varying diameters and lengths. Innovasive's proposed Bio-Interference Screw and Arthrex's Bio-Interference Screw are also molded from the same material: Poly-L-Lactide (L-PLA).
The indication being requested for the proposed Bio-Interference Screw is already cleared for Arthrex's Bio-Interference Screw.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
Bone Model Testing: the ultimate holding strength of the proposed Bio-Interference Screw was compared to the currently marketed Arthrex Bio-Interference Screw. The testing demonstrates substantially equivalent performance between the two devices.
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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 caduceus, a symbol often associated with medicine and healthcare, with three lines representing the staff and a winding snake. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
Ms. Kathleen Morahan Regulatory Affairs Specialist Innovasive Devices, Inc. 734 Forest St. Marlborough, Massachusetts 01752
Re: K990454 Trade Name: Innovasive Bio-Interference Screw Regulatory Class: II Product Code: HWC Dated: May 5, 1999 Received: May 6, 1999
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. A 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
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Page 2 -- Ms. Kathleen Morahan
Product Radiation Control provisions, or other Federal laws or regulations.
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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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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Image /page/4/Picture/0 description: The image shows the word "CONFIDENTIAL" in large, bold letters. Below the word "CONFIDENTIAL" is the text "Page 1 of 1". The text is centered below the word "CONFIDENTIAL".
510(k) Number (if known): K990454
Bio-Interference Screw . Device Name:
Indications for Use:
The Bio-Interference Screw is intended for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × OR
Over-the-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
poole
(Division Sign-Off)
Division of General Restorative Devices K990454
510(k) Number