(89 days)
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is an orthopedic fixation screw used in ACL reconstruction, which is a structural component for graft fixation rather than a device that delivers therapy or has a therapeutic effect on a medical condition.
No
The device, Arthrex Bio-Interference Screw, is described as an implant used for fixation in ACL reconstruction, which is a therapeutic rather than a diagnostic function. It is used to hold a graft in place, not to identify or assess a medical condition.
No
The device description clearly states it is a physical screw and is implanted with accessories, indicating it is a hardware medical device.
Based on the provided information, 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, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Arthrex Bio-Interference Screw is an implantable device used to physically fix a graft to bone within the body during surgery. It does not involve testing or analyzing biological specimens.
- Intended Use: The intended use clearly describes a surgical procedure (ACL reconstruction) and the device's role in providing mechanical fixation.
Therefore, the function and intended use of the Arthrex Bio-Interference Screw fall under the category of a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bio-Interference screw with an expanded indication and the predicate devices are intended to fix a graft to a bone. The Bio-Interference Screw with expanded indications for use and the BioScrew have the same indications for use: to provide interference fixation of bone-tendon-bone and soft tissue grafts in anterior cruciate ligament ("ACL") reconstruction. The devices are indicated for implantation through arthroscopy or arthrotomy.
Product codes
MAI
Device Description
The Arthrex Bio-Interference Screw is a bioabsorbable interference screw made of PLA. It is designed to fix a graft to bone, specifically for interference fixation of bone-tendon-bone and soft tissue grafts in ACL reconstruction. It is implanted using accessories such as a screw sheath, driver, guide wire, dilator, notcher, tap, and remover. The device has a hexagonal head, and some slight modifications include a slight radius on the hexagonal head and a slight taper on the tip. It has similar diameters, thread lengths, overall length, number of threads, and thread pitch to predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bone (specifically for ACL reconstruction involving tibial and femoral tunnels)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon / Arthroscopy or arthrotomy setting
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Arthrex, Inc.'s Bio-Interference Screw, Linvatec's BioScrew
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.
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510(K) SUMMARY FOR ARTHREX, INC.'S BIO-INTERFERENCE SCREW
Submitter's Name, Address, Telephone Number, And Contact Person
Arthrex, Inc. 2885 S. Horseshoe Drive Naples, Florida 34104
JUL - 9 1997
Scott M. Durlacher Contact: Director of Regulatory Affairs and Quality Assurance (610) 296-0919 Phone: Facsimile: (610) 296-2249
Date Prepared
April 10, 1997
Name of the Device
The Arthrex Bio-Interference Screw
Common or Usual Name
Bioabsorbable Interference Screw
Classification Name
17,
Bone Fixation Screw
Predicate Devices
-
- Arthrex, Inc.'s Bio-Interference Screw
-
- Linvatec's BioScrew
Intended Use
The Bio-Interference screw with an expanded indication and the predicate devices are intended to fix a graft to a bone. The Bio-Interference Screw with expanded indications for use and the BioScrew have the same indications for use: to provide interference fixation of bone-tendon-bone and soft tissue grafts in anterior cruciate ligament ("ACL") reconstruction. The devices are indicated for implantation through arthroscopy or arthrotomy.
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Principles of Operation
In an ACL reconstruction, the surgeon: (1) creates tibial and femoral tunnels; (2) harvests and prepares a graft; (3) places the graft in the tunnels; and (4) inserts screws between the tunnel wall and graft to hold the graft in place. The ACL reconstruction procedure is similar regardless of whether Linvated's BioScrew, Arthrex's cleared Bio-Interference Screw, or Arthrex's Bio-Interference Screw with an expanded indication is used. The only difference between the techniques to implant the Bio-Interference Screw with an expanded indication and Linvatec's BioScrew is the method of attaching the driver to the screw during insertion. Moreover, the only differences between the implantation techniques for the cleared Bio-Interference Screw and Bio-Interference Screw with an expanded indication are the preparation of the graft and type of tissue against which the screw is inserted.
During a soft tissue graft ACL reconstruction with Linvatec's BioScrew or Arthrex's Bio-Interference Screw with an expanded indication, the surgeon cores tunnels in the tibia and femur and removes the bone cores. The surgeon then removes a portion of a tendon, such as the hamstring, patella, tendonisis, or gracilis. The surgeon next prepares the soft tissue graft by folding the graft in half and, with a suture, whip stitching each end of the tendon for a distance of 3 cm; the whip stitching helps prevent the graft from wrapping up when the screw is introduced. After graft preparation, the surgeon places one end of the graft in the tibial tunnel and the other end in the femur tunnel. To fix the graft ends in the tunnels, the surgeon inserts the screws using a driver supplied by the screw manufacturer; the screws fit between the soft tissue grafts and tunnel walls. Both the Bio-Interference Screw and BioScrew are inserted through a sheath accessory that protects the graft from damage by the screw threads during insertion.
The principal difference in the insertion techniques of Linvatec's BioScrew and Arthrex's Bio-Interference Screw with an expanded indication is the method of attaching the driver to the screw during insertion. Whereas Arthrex's driver has a hexagonal socket that fits over Arthrex's hexagonal-headed screw, Linvatec's driver has three lobes that fit into Linvatec's screw. This difference does not raise any new issues of safety or effectiveness because use of a hexagonalheaded screw has a minor impact on how the screw is deployed: Arthrex and Linvated's drivers are placed against the screw and torque is applied to the screw by the surgeon through the driver.
Technological Characteristics
There are no technological differences between the cleared Bio-Interference Screw and the Bio-Interference Screw with the expanded indication except for a slight radius on the hexagonal head and a slight taper on the tip; these modifications are very minor. The Bio-Interference Screw also has technological characters very similar to the BioScrew. For instance, they are made of bioabsorbable PLA. They have the same diameters and very similar thread
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lengths, overall length, number of threads, and thread pitch. The minor difference in length, 2 mm, between Linvatec's 25 mm screw and Arthrex's 23 mm screw does not raise any new issues of safety or effectiveness because the magnitude of the difference is small. Furthermore, the length of the Bio-Interference Screw with an expanded indication is within the range of the lengths of the cleared BioScrew.
The cleared Bio-Interference Screw and the Bio-Interference Screw with an expanded indication are implanted with the same accessories: a screw sheath, driver, guide wire, dilator, notcher, tap, and remover. In addition, the Bio-Interference Screw with the expanded indication and the BioScrew also are implanted with similar accessories: screw sheaths, guide wires, taps, notchers, and drivers. The BioScrew's accessories also are made of materials such as stainless steel and aluminum.
The Bio-Interference Screw has the same intended use and indications for use as the BioScrew. In addition they both have very similar principles of operation and technological characteristics. Furthermore, except for the radius and taper modification, the Bio-Interference Screw has not been modified since it was cleared by FDA in a previous 510(k) notice. Thus, the Bio-Interference Screw is substantially equivalent to the BioScrew for interference fixation of bone-tendonbone and soft tissue grafts in ACL reconstruction.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three lines representing the three branches of government.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jonathan S. Kahan Hogan and Hartson L.L.P. Representing Arthrex, Inc. ... . . 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109
JUL - 9 1997
Re : K971358 Trade Name: Bio-Interference Screw Requlatory Class: II Product Code: MAI Dated: April 11, 1997 Received: April 11, 1997
Dear Mr. Kahan:
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 reqistration, 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 Requlation (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
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Page 2 - Mr. Jonathan S. Kahan
comply with the GMP regulation may result in regulatory 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 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 diaqnostic 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Cella 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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510(k) Number (if known): _
Bio-Interference Screw Device Name:
Indications For Use:
To provide interference fixation of bone-tendon-bone and soft tissue-grafts in ACL reconstruction through arthroscopy or arthrotorry.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
coo
(Division Sign-Off) Division of General Restorative Devices 16971358 510(k) Number_
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)