(76 days)
TiMesh® System, Centre-Drive Drill-Free™ Screws, LEIBINGER® Bone Plates and Bone Screws
Not Found
No
The device description and intended use focus on mechanical fixation components (screws, plates, instruments) and do not mention any software, algorithms, or capabilities related to AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is intended for internal fixation of small bones affected by trauma or for reconstruction or arthrodesis, which are therapeutic applications.
No
The device is described as a system for internal fixation of small bones and burr hole covers, using screws and plates. It provides a means to physically stabilize or repair bones, rather than to diagnose medical conditions or diseases.
No
The device description explicitly states that the system includes physical components such as titanium screws, plates, and reusable instruments (screwdrivers, handles, blades, etc.). This indicates it is a hardware-based medical device, not software-only.
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 (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Description: The Integra Bone Fixation System is described as being used for the internal fixation of bones. This involves surgically implanting screws and plates inside the body to stabilize bone fragments.
- Intended Use: The intended use is for internal fixation of small bones, reconstruction, arthrodesis, and covering burr holes. These are all surgical procedures performed on the body, not tests performed on samples from the body.
Therefore, based on the provided information, the Integra Bone Fixation System is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Integra Bone Fixation System is intended for use in internal fixation of small bones affected by trauma or for reconstruction or arthrodesis. Burr hole cover plates are intended specifically to cover burr holes and to secure cranial flaps.
Product codes
HRS, HWC, GXN
Device Description
The Integra Bone Fixation System includes titanium self-tapping and/or self-drilling screws and plates along with instruments for the internal fixation of bone fragments. The fixation screws are supplied in a variety of diameters and lengths designed to fit Integra's various designs of fixation plates and burr hole covers. The Integra Bone Fixation System includes reusable instruments such as screwdrivers, handles and blades, plate holders, drill bits and instrument trays. The single use fixation plates and screws, and the reusable instruments are provided non-sterile and must be sterilized prior to use. The basic design, intended use, materials, and principles of operation of the Integra Bone Fixation System are equivalent to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones, burr holes, cranial flaps
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
TiMesh® System, Centre-Drive Drill-Free™ Screws, LEIBINGER® Bone Plates and Bone Screws
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Integra LifeSciences Corporation Premarket Notification 510(k) Integra Bone Fixation System
Integra Bone Fixation System
040860
page 1 of 1
510(k) Summary
Submitter's name and address:
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536
Contact person and telephone number:
Donna R. Wallace Director Regulatory Affairs (609) 275-0500
Date prepared: April 1, 2004
Name of device:
Proprietary Name: Common Name: Classification Name: Integra Bone Fixation System Bone Fixation Plates and Screws Bone Fixation Plates Bone Fixation Screws Burr Hole Covers
Substantial Equivalence:
The Integra Bone Fixation System is substantially equivalent to the commercially distributed predicate devices, the TiMesh® System, the Centre-Drive Drill-Free™ Screws, and the LEIBINGER® Bone Plates and Bone Screws.
Intended Use:
The Integra Bone Fixation System is intended for use in internal fixation of small bones affected by trauma or for reconstruction or arthrodesis. Burr hole cover plates are intended specifically to cover burr holes and to secure cranial flaps.
Device Description:
The Integra Bone Fixation System includes titanium self-tapping and/or self-drilling screws and plates along with instruments for the internal fixation of bone fragments. The fixation screws are supplied in a variety of diameters and lengths designed to fit Integra's various designs of fixation plates and burr hole covers. The Integra Bone Fixation System includes reusable instruments such as screwdrivers, handles and blades, plate holders, drill bits and instrument trays. The single use fixation plates and screws, and the reusable instruments are provided non-sterile and must be sterilized prior to use. The basic design, intended use, materials, and principles of operation of the Integra Bone Fixation System are equivalent to the predicate devices.
Conclusion:
The Integra Bone Fixation System is substantially equivalent to other commercially marketed devices and does not raise new issues of safety and effectiveness.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles three curved lines or strokes, possibly representing human figures or abstract shapes. The overall design is simple and clean, with a focus on the text and the central symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
Donna R. Wallace, RAC Director, Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K040860
Trade/Device Name: Integra Bone Fixation System Trade/Device Name: - mogia Ecoa8.3030, 21 CFR 888.3040, 21 CFR 882.5330 Regulation Nambers: Bir Crisione component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener, Preformed nonalterable cranioplasty plate
Regulatory Class: II Product Codes: HRS, HWC, GXN Dated: April 1, 2004 Received: April 2, 2004
Dear Ms. Wallace:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosule) to regars and ment date of the Medical Device American processed on The Continerec prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic recry there the device, subject to the general controls provisions of the Act. The r ou may, dierolore, manel of the Act include requirements for annual registration, listing of general controls provisioning practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 above) als. Existing major regulations affecting your device can may be subject to satin additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Dri 3 lossants of our device complies with other requirements of the Act that I Dri has made a aoved regulations administered by other Federal agencies. You must or any I cacal statutes and registments, including, but not limited to: registration and listing (21 Comply with an the 7te 31equirements) news 801); good manufacturing practice requirements as set CI It Fut 607); adoning (2 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your antial equivalence of your device to a legally premarket notification: "The Presults 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), please If you desire specific advice for Jour ac (301) 594-4659. Also, please note the regulation entitled, a Colliact the Office of Compulance in (21CFR Part 807.97). You may obtain Misolanung by Iciercher to premailso nibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Mellekers
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): KOH0860
Device Name: Integra Bone Fixation System
Indications For Use:
The Integra Bone Fixation System is intended for use in internal fixation of small bones affected by trauma, for reconstruction, or arthrodesis. Burr hole cover plates are intended specifically to cover burr holes and to secure cranial flaps.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Milkerson
. Restorative, Division - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
510(k) Number-