(29 days)
Not Found
Not Found
No
The summary describes a mechanical bone screw for ACL reconstruction and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is a bone screw used in ACL reconstruction procedures to hold grafts in place, which is a therapeutic intervention.
No
Explanation: The device is a bone screw used for interference fixation in ACL reconstruction procedures, which is a therapeutic function, not a diagnostic one. It is used to hold a graft in place rather than to identify or analyze a medical condition.
No
The device description explicitly states it is a "cannulated, sterile, single use bone screw manufactured from a composite mix of calcium phosphate and poly L-lactic acid (PLLA)," indicating it is a physical hardware device.
Based on the provided information, the Bilok® Screw is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for fixing grafts during ACL reconstruction. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is described as a bone screw made of a composite material, designed to be implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The Bilok® Screw is a surgical implant used for mechanical support within the body.
N/A
Intended Use / Indications for Use
The Bilok® Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place.
The Bilok® Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
The Bilok® Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Bilok® 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
Not Found
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)
Non Clinical Testing
Documentation provided demonstrates that the Bilok® Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness.
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.
Not Found
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.
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K07109/ page 1 of 2
MAY 17 2007
510(k) SUMMARY
Bilok® Screw
Applicant Biocomposites Ltd 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: Common/Usual Name: Trade/Proprietary Name Product Code
Screw, fixation, bone Bone screw Bilok® Screw HWC
21CFR888.3040
CFR Section
Device Description
The Bilok® 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® Screw has the exact same intended use and indications as the predicate device.
The Bilok® Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place.
The Bilok® Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
The Bilok® Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
1
Page 2 of 2
Summary of Technology
The Bilok® 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® 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® 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® 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 consists of a stylized eagle with three stripes representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 2007
Biocomposites Ltd % Mr. Simon Fitzer Quality and Regulatory Affairs Manager Keele Science Park Keele, Staffordshire England, ST5 5NL
Re: K071091
Trade/Device Name: Bilok® Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 4, 2007 Received: April 18, 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. Iisting 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.
Barbara Buehrle
Mark N. Mel Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): Ko 71 09/
Bilok® Screw
Indications For Use:
Device Name:
The Bilok® Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place.
The Bilok® Screw is used to provide interference fixation of patellar bonetendon-bone grafts in ACL reconstruction.
The Bilok® Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi tendonosis gracilis).
Prescription Use (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
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chubare Richardson
Division Sign Off
Division and Neurological Device
Page 1 of 1
510(k) Number K071091