(182 days)
Bio Interference Screw, BioScrew
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 or ML.
No
The BioLok® Screw is a bone screw used for interference fixation of grafts in ACL reconstruction procedures, which is a supportive device for a surgical procedure, not a therapeutic device.
No
Explanation: The BioLok® Screw is a bone screw used for interference fixation of grafts in ACL reconstruction procedures, which is a therapeutic and reconstructive function, not a diagnostic one. It holds the graft in place rather than identifying or assessing a medical condition.
No
The device description explicitly states it is a physical bone screw made of absorbable polymer, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- BioLok® Screw Function: The BioLok® Screw is a surgical implant used to physically secure a graft during ACL reconstruction surgery. It is inserted directly into the patient's body to provide mechanical support.
The description clearly indicates a surgical device used in vivo (within the living body) for structural support, not a device used to analyze samples in vitro (outside the living body).
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
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, femoral
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 favorably with the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bio Interference Screw (Arthrex), BioScrew (Linvatec)
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
510(k) Summary of Safety and Effectiveness
| (1) | Submitter's name: | Encore Orthopedics, Inc. |
|---|---|---|
| Submitter's address: | 9800 Metric Blvd, Austin, TX 78758 | |
| Submitter's telephone number: | 512) 834-6237 | |
| Contact person: | Debbie De Los Santos | |
| Date summary prepared: | October 14, 1999 | |
| (2) | Trade or proprietary device name: | BioLok® Screw |
| Common or usual name: | Bone Fixation Screw | |
| Classification name: | Class II | |
| (3) | Legally marketed predicate device: | Bio Interference Screw (Arthrex) |
| BioScrew (Linvatec) |
Subject device description: (4)
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).
(ર) 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).
Technological characteristics: (6)
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 favorably with the predicate devices.
Basis for substantial equivalence: (8)
The BioLok® Screw is equivalent in design, materials and indications to the predicate devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2000
Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore Medical Corporation 9800 Metric Boulevard Austin, Texas 78758
Re: K993630
Trade Name: BioLok® Screw Regulatory Class: II Product Code: HWC Dated: February 4, 2000 Received: February 7, 2000
Dear Ms. Los Santos:
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 control provisions of the Act. The general control 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 (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.
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.
2
Page 2 - Ms. Debbie De Los Santos
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,
ymne R. lichner.
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
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ______________________________________________________________________________________________________
Indications For Use:
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-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).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dams R. Lochner.
(Division S
Restorative Devices
number K993630
Prescription Use _ V (per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)_