(265 days)
Not Found
No
The summary describes a physical, absorbable bone screw and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as an interference screw for fixation of a soft tissue graft, which is a structural component of a surgical procedure rather than a device that provides therapy.
No
The device is described as an "interference screw" used for fixation during ACL and PCL reconstruction, indicating it is a surgical implant rather than a tool for diagnosis.
No
The device description clearly states it is a physical bone screw made of Poly (L-Lactic Acid), which is a hardware component.
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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a bone screw) used for fixing a soft tissue graft during ACL and PCL reconstruction. This is a device used within the body for a structural purpose, not for testing samples outside the body.
The description focuses on the physical characteristics of the screw and its surgical application, which is entirely different from the function of an IVD.
N/A
Intended Use / Indications for Use
The BioScrew® XtraLok™ interference screw provides tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.
Product codes
MAI, HWC
Device Description
The BioScrew Xtralok™ is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-Lactic Acid).
The BioScrew XtraLok will be available in 6 sizes: 9, 10, and 11mm diameters by 35 or 40mm lengths. The proximal face is angled from the axis of the BioScrew, and the proximal region of the threaded body tapers to a larger diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
K°/3/3/
JUN 1 1 2002
3/12/02
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the BioScrew® XtraLok™ Bioabsorbable Interference Screw 510(k) Number K013131
A. Submitter
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Company Contact B.
Laura D. Seneff, RAC Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX
C. Device Name
Trade Name: BioScrew® XtraLok™
Common Name: Bioabsorbable Interference Screw
Classification Names: Fastener, Fixation, Biodegradable, Soft Tissue
Proposed Class/Device: Class II Product Code MAI
1
page 1 of 2
Summary of Safety and Effectiveness BioScrew® XtraLok Bioabsorbable Interference Screw 510(k) # K013131 3/12/02 Page 2 of 2
D. Predicate/Legally Marketed Devices
Linvatec BioScrew® 510(k)# K973758
ப் Device Description
The BioScrew Xtralok™ is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-Lactic Acid).
The BioScrew XtraLok will be available in 6 sizes: 9, 10, and 11mm diameters by 35 or 40mm lengths. The proximal face is angled from the axis of the BioScrew, and the proximal region of the threaded body tapers to a larger diameter.
F. Intended Use
The BioScrew XtraLok provides tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.
G. Substantial Equivalence
The BioScrew XtraLok is substantially equivalent in design, materials and intended use to the Linvatec BioScrew interference screw. The BioScrew XtraLok interference screw does not raise any new issues of safety or effectiveness when compared to this predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of what appears to be an eagle or bird-like figure, composed of three curved lines that suggest movement or flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 2002
Ms. Laura D. Seneff, RAC Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K013131
Trade/Device Name: BioScrew XtraLok™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 12, 2002 Received: March 13, 2002
Dear Ms. Seneff:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Laura D. Seneff, RAC
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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 Mllhums
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
4
9/18/01
510(k) Number (if known): K0/3/3/
Device Name: Bioabsorbable Interference Screw
Indications for Use:
The BioScrew® XtraLok™ interference screw provides tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use$\frac{2}{7}$ OR
Over-the-Counter Use No
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Mark M. Melhem
Division of General, Restorative and Neurological Devices
510(k) Number _