(25 days)
Not Found
No
The device description and intended use are purely mechanical and material-based, with no mention of software, algorithms, or data processing that would indicate AI/ML. The modifications described are physical (size and color).
Yes
The device is used for tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction, which is a therapeutic intervention.
No
The device is described as a bone screw used for fixation in ACL and PCL reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical bone screw made of absorbable material, 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant (a bone screw) used for fixing a soft tissue graft during ACL and PCL reconstruction. It is inserted directly into the body.
- Intended Use: The intended use is for "tibial interference fixation of a soft tissue graft," which is a surgical procedure, not an in vitro test.
The device is a medical device, but it falls under the category of a surgical implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm,violet, provide tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet are cannulated, sterile, single-use bone screws made of an absorbable homopolymer derived from Poly (L-Lactic Acid).
Two sizes will be available for the device, 8 x 35mm and 8 x 40mm. The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet, differ from the existing Linvatec BioScrew® XtraLok™ in that the major diameter is smaller. The violet colorant contained in this device, has been cleared for this product code and intended use by the FDA via color petition 8C0255 dated January 28, 1998.
The modification does not affect the device's intended use, fundamental scientific technology or performance specifications.
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): 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.
0
MAR 2 5 2005
PROPRIETARY INFORMATION – LINVATEC CORPORATION
February 8, 2005
510(k) Submission
Summary of Safety and Effectiveness
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR In accordance with the requirements of submitting a Special 510(k) Summary of Safety and 007.92, Linvatec Corporation is net 05 - 35mm-Violet and BioScrew® XtraLok® 8 x 40mm-Violet, 510(k) Number Koro49.7
Submitter A.
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Company Contact B.
Elizabeth Paul Manager, Regulatory Affairs Telephone (727) 399-5234 (727) 399-5264 FAX
C. Device Name
Trade Name: BioScrew® XtraLok® 8 x 35mm-Violet and BioScrew® XtraLok® 8 x 40mm-Violet
Bioabsorbable Interference Screw Common Name:
Classification Names: Fastener, Fixation, Biodegradable, Soft Tissue
| Proposed Class/Device: | Class II |
|---|---|
| Product Code | HWC |
1
PROPRIETARY INFORMATION - LINVATEC CORPORATION
February 8, 2005 510(k) Submission BioScrew® XtraLok® 8 x 35mm and 8 x 40mm,violet 510(k) # _____________________________________________________________________________________________________________________________________________________________________
Predicate/Legally Marketed Devices D.
BioScrew® XtraLok™ 510(k)# K013131 Linvatec Corporation
Device Description E.
The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet are cannulated, sterile, single-use bone screws made of an absorbable homopolymer derived from Poly (L-Lactic Acid).
Two sizes will be availablé for the device, 8 x 35mm and 8 x 40mm. The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet, differ from the existing Linvatec BioScrew® XtraLok™ in that the major diameter is smaller. The violet colorant contained in this device, has been cleared for this product code and intended use by the FDA via color petition 8C0255 dated January 28, 1998.
The modification does not affect the device's intended use, fundamental scientific technology or performance specifications.
F. Intended Use
The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm,violet, provide tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.
Substantial Equivalence G.
The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet, are substantially equivalent in design, materials and intended use to the BioScrew@ XtraLok™. The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet, do not raise any new issues of safety or effectiveness when compared to this predicate device.
2
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is presented in a straightforward manner. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line.
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is positioned above the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA", which is arranged in a circular fashion around the logo.
MAR 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Paul Manager, Regulatory Affairs Linvatec Corp. 11311 Concept Boulevard. Largo, Florida 33773-4908
Re: K050497
Trade/Device Name: Bioscrew® XtraLokTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 15, 2005 Received: February 28, 2005
Dear Ms. Paul:
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. Elizabeth Paul
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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/industry/support/index.html
Sincerely yours,
Hupk Rludu
iriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
PROPRIETARY INFORMATION - LINVATEC CORPORATION
Indications for Use
12050497
510(k) Number (if known):_
Device Name: BioScrew® XtraLok® 8 x 35mm-Violet and BioScrew® XtraLok® 8 x 40mm-Violet
Indications for Use:
The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet provide tibial The Drosciow of Atranse of a soft tissue graft for ACL and PCL reconstruction.
Prescription Use_X__ OR (Part 21 CFR 801 subpart D)
Over-the-Counter Use______ (Part 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)
Hpp. Rludi
Sign-Off (Division Division of General, Restorative, and Neurological Devices
Page 1 of ___ 1__
510(k) Number K050497