(49 days)
Not Found
Not Found
No
The summary describes a physical implantable device (a bone screw) and its material composition and intended use in ACL reconstruction. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No
The device is a surgical fixation screw used in ACL reconstruction, providing mechanical support rather than directly treating a disease or condition through physiological means.
No
Explanation: The device is a BioLok® Screw, an implantable bone screw used in ACL reconstruction for graft fixation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical bone screw made of absorbable polymer, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure involving the fixation of a graft within bone tunnels during ACL reconstruction. This is a direct surgical intervention on the body.
- Device Description: The device is a bone screw made of absorbable polymer, designed to be implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The BioLok® 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 BioLok® Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
The BioLok® 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 BioLok® Screw is a cannulated, sterile, single-use bone screw made of an absorbable polymer similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The BioLok® Screw is manufactured from a mixture of Tri-Calcium Phosphate (TCP) and poly (L-lactide) (PLLA).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibial and/or femoral tunnels
ACL
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Test results confirm that this composite has the requisite strength over time to provide early and sustained fixation of the graft. Pull out test results compare favourably with the predicate devices.
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.
0
AUG 2 5 2000
510(K) Summary of Safety and Effectiver
-
(1) Submitter's name: Submitter's address:
Submitter's telephone number: Contact person: Date summary prepared: -
(2) Trade or proprietary device name: Common or usual name: Classification name:
Biocomposites Ltd Etruscan Street, Etruria, Stoke-on-Trent, ST1 5PQ, England 44 (0) 1782 206500 Stephen Bratt July 3rd, 2000 -
BioLok® Screw Bone Fixation Screw Class II
-
(3) Legally marketed predicate device:
Bio Interference Screw (Arthrex) BioScrew (Livatec)
(4) Subject device description:
The BioLok® Screw is a cannulated, sterile, single-use bone screw made of an absorbable polymer similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The BioLok® Screw is manufactured from a mixture of Tri-Calcium Phosphate (TCP) and poly (L-lactide) (PLLA).
(5) Subject device intended use:
The BioLok® 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 BioLok® Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
The BioLok® Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
(6) Technological characteristics:
The BioLok® Screw has the same technological characteristics (i.e., design and material) when compared to the predicate devices.
(7) Performance data:
Test results confirm that this composite has the requisite strength over time to provide early and sustained fixation of the graft. Pull out test results compare favourably with the predicate devices.
(8) Basis for substantial equivalence:
The BioLok® Screw is equivalent in design, materials and indications to the predicate devices.
1
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2000
Mr. J. Stephen Bratt Biocomposites Ltd. Etruscan Street, Etruria Stoke-on-Trent Staffordshire, ST1 5PQ United Kingdom
Re: K002070
Trade Name: BioLok® Screw Regulatory Class: II Product Code: HWC Dated: July 3, 2000 Received: July 7, 2000
Dear Mr. Bratt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Spècial Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. J. Stephen Bratt
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Hunell Lyon
JCelia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page _ of _
| 510(k) Number (if known): | K002070 |
|---|---|
| Device Name: | BioLok Screw |
Indications For Use:
The BioLok® 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 BioLok® Screw is used to provide interference fixation of patellar bone-tendonbone grafts in ACL reconstruction.
The BioLok® Screw is used to provide interference fixation during femoral and/or The Block Screw is assoc to provise using a soft tissue graft (semi-tendonosis gracilis).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General Restorative Devices Coopolo 510(k) Number _
Prescription Use_ mer (Per 21 CFR 801.109)
OR
Over-The-Counter Use No
(Optional Format 1-2-96)