(27 days)
Not Found
Not Found
No
The summary describes a mechanical bone screw for ACL reconstruction and does not mention any software, image processing, or AI/ML terms.
No
The device is a bone screw used for fixation during ACL reconstruction, which is a supportive role in a surgical procedure, not a device that itself provides therapy.
No
The device, Bilok® ST Screw, is described as a bone screw used for fixation during ACL reconstruction procedures, not for diagnostic purposes. Its function is to provide mechanical support, not to identify or monitor medical conditions.
No
The device description clearly states it is a physical bone screw manufactured from a composite material, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Bilok® ST Screw is a surgical implant used to fix a graft during ACL reconstruction. It is a physical device inserted into the body, not a test performed on a sample outside the body.
The provided information clearly describes a surgical implant for orthopedic procedures, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Bilok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.
The Bilok® ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.
Product codes
HWC
Device Description
The Bilok® ST Screw is a cannulated, sterile, single use bone screw manufactured from a composite mix of calcium phosphate and poly L-lactic acid (PLLA).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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K07115 page 1/2
510(k) SUMMARY
Bilok® ST Screw
MAY 1 7 2007
Biocomposites Ltd Applicant Keele Science Park Keele Staffordshire England ST5 SNL
Contact Person Mr Simon Fitzer Tel: +44 (0) 1782 338580 +44 (0) 1782 338599 Fax Email: sf@biocomposites.com
| Classification Name: | Screw, fixation, bone |
|---|---|
| Common/Usual Name: | Bone screw |
| Trade/Proprietary Name | Bilok® ST Screw |
| Product Code | HWC |
| CFR Section | 21CFR888.3040 |
Device Description
The Bilok® ST Screw is a cannulated, sterile, single use bone screw manufactured from a composite mix of calcium phosphate and poly L-lactic acid (PLLA).
Intended Use / Indications
The Bilok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.
The Bilok® ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.
1
Summary of Technology
The Bilok® ST Screw has the same technological characteristics as the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness.
Non Clinical Testing
Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness.
Substantial Equivalence
Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness.
Safety and Performance
Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biocomposites Ltd % Mr. Simon Fitzer Quality and Regulatory Affairs Manager Keele Science Park Keele, Staffordshire England, ST5 5NL
MAY 17 2007
Re: K071115
Trade/Device Name: Bilok® ST Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 12, 2007 Received: April 20, 2007
Dear Mr. Fitzer:
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
3
Page 2 – Mr. Simon Fitzer
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.
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" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Spoubare buehr
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Bilok® ST Screw
Indications For Use:
The Bilok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.
The Bilok®ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.
Prescription Use (Part 21 CFR 801 Subpart D)
OR
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)
Sarhare Buchn
Division of General, Restorative. and Neurological Devices
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510(k) Number K071115