(87 days)
No
The summary describes a mechanical screw for ACL reconstruction and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a screw used for fixation during ACL reconstruction, which is a medical device for structural support rather than a therapeutic intervention itself.
No
The BiLok® ST Screw is an implantable device used in ACL reconstruction procedures for fixation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical screw made of a composite material, intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for anterior cruciate ligament (ACL) reconstruction procedures, specifically for providing suspensory fixation during femoral fixation. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a screw made of a composite material, designed to be implanted into bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
Therefore, the BiLok® ST Screw is a surgical implant, not an in vitro diagnostic device.
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 a double looped (semitendinosus/gracilis) or quadruple (semitendinosus) graft.
Product codes
HWC
Device Description
The cannulated BiLok® ST Screws are 6 – 9mm diameters and 30 – 40mm lengths.
The Bil.ok® ST Screw is moulded from a Poly L lactide/Beta Tri-Calcium Phosphate composite.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral bone tunnel, knee
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)
Arthrex Bio Transfix cross pin K011172, BiLok Screw K002070, Biosteon Cross Pin K021351
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.
0
K033792 pg 114
MAR - 1 2004
510(K) Summary
Submitter
| Name: | Biocomposites Ltd |
|---|---|
| Address: | Etruscan Street |
| Etruria | |
| Stoke on Trent | |
| ST1 5PQ | |
| England | |
| Tel No: | +44 (0) 1782 206500 |
| Contact: | Mr J. S. Bratt |
| Date: | 24th November 2003 |
Name of Device
Classification Name: Bone fixation fastener Common Name: Threaded Fixation Pin Bioresorbable ACL device Proprietary Name: BiLok® ST Screw
Predicate Device
Arthrex Bio Transfix cross pin K011172 BiLok Screw K002070 Biosteon Cross Pin K021351
Device Function
To hold a soft tissue graft in position during healing in the femoral bone tunnel.
Device Design
The cannulated BiLok® ST Screws are 6 – 9mm diameters and 30 – 40mm lengths.
Materials Used
The Bil.ok® ST Screw is moulded from a Poly L lactide/Beta Tri-Calcium Phosphate composite.
Intended Use
To hold a Semitendinosus ST or hamstring (soft tissue) graft in place in the femoral tunnel during the healing period following ACL reconstructive surgery.
Substantial Equivalence
The material of construction and methods of manufacture, packaging and sterilization of the BiLok® ST Screw are identical to the previously cleared BiLok Screw K002070
1
K011792 page 2 of 2
The function and indications for use of the BiLok® ST Screw are the same as for the Arthrex Bio Transfix Cross Pin K011172 and the Biosteon Cross Pin K021351.
The functional mechanical performance characteristics of the BiLok® ST Screw are equivalent to those of the Arthrex Bio Transfix Cross Pin and the Biosteon Cross Pin. Any differences between the BiLok Screw and the predicate devices do not raise any new questions regarding safety and effectiveness.
Indications for use
Surgical reconstruction of anterior cruciate ligament (ACL) deficient knee to provide cross screw femoral fixation of the various soft tissue ACL autografts and allografts.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2004
Mr. J. Stephen Bratt Managing Director Biocomposites Ltd. Etruscan Street, Etruria Stoke on Trent Staffordshire, ST1 5PQ United Kingdom
Re: K033792
Trade/Device Name: BiLok® ST Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 24, 2003 Received: December 5, 2003
Dear Mr. Bratt:
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 rcquirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. J. Stephen Bratt
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 (301) 594-4639. 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Milkerso
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
Indications for Use
510(k) Number (if known): K033792
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 a double looped (semitendinosus/gracilis) or quadruple (semitendinosus) graft.
Prescription Use 4 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
fo Mack N Melkerm
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of __
510(k) Number. K033792