(26 days)
Not Found
No
The 510(k) summary describes a purely mechanical, biodegradable interference screw for surgical fixation. There is no mention of any software, data processing, or analytical capabilities that would suggest the use of AI or ML. The performance studies focus on mechanical properties like holding strength and insertion force.
Yes
The device is used for fixation of grafts during ligament reconstruction, which is a therapeutic intervention.
No
Explanation: The document describes the Absolute™ Absorbable Interference Screws as devices for fixing grafts during knee ligament reconstruction surgeries. This clearly indicates a therapeutic or surgical purpose, not a diagnostic one. Diagnostic devices are used to identify or determine the nature of a disease or condition.
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:
- Intended Use: The intended use is for the fixation of grafts during knee surgery. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a physical screw used to secure tissue within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health. This device does not perform any such analysis.
The information provided clearly describes a surgical implant, not a diagnostic test performed on biological samples.
No.
A Predetermined Change Control Plan (PCCP) is primarily associated with artificial intelligence/machine learning (AI/ML)-enabled medical devices, outlining how modifications to the device's algorithm, data inputs, or intended use will be managed post-market. This clearance letter does not mention any AI/ML components, image processing, or complex adaptive algorithms that would necessitate a PCCP. The device is a traditional biodegradable interference screw, and the performance studies focus on mechanical properties rather than software or algorithmic performance.
Intended Use / Indications for Use
The 11mm & 12mm Absolute™ Absorbable Interference Screws are intended for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Absolute™ Absorbable Interference Screw is a biodegradable interference screw intended for interference fit fixation of soft tissue grafts or bone-tendonbone grafts during cruciate ligament reconstruction surgeries of the knee. The device is offered in 11mm and 12mm diameters and 30mm in length.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bone Model Testing: the ultimate holding strength of the Absolute™ Absorbable Interference Screw, the force to insert and strip the screw.
The testing demonstrates substantially equivalent performance between the proposed and predicate devices.
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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Image /page/0/Picture/0 description: The image shows the logo for Innovative Devices. The logo consists of a stylized "IA" symbol on the left, followed by the words "INNOVASIVE" in a bold, slanted font. Below "INNOVASIVE" is the word "DEVICES" in a smaller, sans-serif font. The logo is black and white.
K993975
DEC 20 1999
510(K) SUMMARY Special 510(k)
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: November 19, 1999
2. DEVICE:
Trade Name: Innovasive Absolute™ Absorbable Interference Screw (11mm and 12mm)
Common Name: Interference Screw
Classification Name: Not Classified
3. PREDICATE DEVICE:
(1) Innovasive Bio-Interference Screw - K900454
4. DEVICE DESCRIPTION:
The Absolute™ Absorbable Interference Screw is a biodegradable interference screw intended for interference fit fixation of soft tissue grafts or bone-tendonbone grafts during cruciate ligament reconstruction surgeries of the knee. The device is offered in 11mm and 12mm diameters and 30mm in length.
5. INTENDED USE:
The Absolute™ Absorbable 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 Absolute™ Absorbable Interference Screw is identical to the Bio-absorbable Interference Screw with the exception of the outside diameter. Both devices are cannulated, threaded, tapered, and molded from the same material: Poly-L-Lactide (L-PLA).
The indication being requested for the Absolute™ Absorbable Interference Screw is already cleared for predicate Bio-Interference Screw.
7. PERFORMANCE DATA:
The following performance testing was performed in support of the substantial equivalence determination:
Bone Model Testing: the ultimate holding strength of the Absolute™ Absorbable Interference Screw, the force to insert and strip the screw.
The testing demonstrates substantially equivalent performance between the proposed and predicate devices.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 1999
Ms. Kathleen Morahan Regulatory Affairs Specialist Innovasive Device, Inc. 734 Forest St. Marlborough, MA 01752
Re: K993975
Trade Name: Absolute Absorbable Interference Screw Regulatory Class: II Product Code: HWC Dated: November 19, 1999 Received: November 24, 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 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
Neil R.P. Ogden
James E. Dillard III for
Acting 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
11mm & 12mm Absolute™ Absorbable Interference Screw
The 11mm & 12mm Absolute™ Absorbable Interference Screws are intended for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
for
vision Sign-Off) vision of General Restorative Devices K993975 5 : 0(k) Number _
પદડ Prescription Use (Per 21 CFR 801.109)