(30 days)
Not Found
No
The device description and intended use focus on a resorbable screw and washer for ligament repair and reconstruction, with no mention of AI or ML capabilities.
No.
The device is an orthopedic implant (screw and washer) for ligament and tendon repair, which is a structural component for fixation and not a device that provides therapeutic energy or substance.
No
This device is a screw and washer system used for orthopedic fixation, not for diagnosing conditions.
No
The device description clearly indicates it is a physical implantable device made of a resorbable copolymer, 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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The LactoSorb® Tibial L-15 Screw and Washer is a resorbable implant designed for surgical fixation of ligaments and tendons in the knee. It is physically implanted into the body.
- Intended Use: The intended uses listed are all surgical procedures involving the repair and reconstruction of ligaments and tendons. This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
The information provided clearly describes a surgical implant used for structural support and fixation within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LactoSorb® Tibial L-15 Screw and Washer is indicated for the following procedures:
-
- ACL and PCL reconstruction
-
- Medial collateral ligament repair
-
- Lateral collateral ligament repair
-
- Posterior oblique ligament repair
-
- Iliotibial band tenodesis reconstruction
-
- Patellar ligament and tendon repair
This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.
Product codes
HWC, MAI
Device Description
The device description of the LactoSorb® Tibial L-15 Screw and Washer is as follows:
- Resorbable screw in varying diameters
- Screw pre-assembled with a washer .
- Fixation achieved by sandwiching the soft tissue between the two washers . and screwing into the bone
- 85% L-Lactide/15% Glycolide copolymer .
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
Non-Clinical Testing: Mechanical testing demonstrated pull-out testing comparable to the predicate device.
Clinical Testing: None provided
Key Metrics
Not Found
Predicate Device(s)
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
033233 1/2
NOV - 5 2003
BIOMET
510(k) Summary
Applicant/Sponsor:Biomet Orthopedics, Inc.
Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist
Proprietary Name: LactoSorb® Tibial L-15 Screw and Washer
Common Name: Non-metallic screw and washer
Classification Name: Screw, Fixation, Bone, Non-Spinal, Non-Metallic (21 CFR 888.3040
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer cleared in 510(k) K021832).
Device Description: The device description of the LactoSorb® Tibial L-15 Screw and Washer is as follows:
- · Resorbable screw in varying diameters
- Screw pre-assembled with a washer .
- Fixation achieved by sandwiching the soft tissue between the two washers . and screwing into the bone
- 85% L-Lactide/15% Glycolide copolymer .
Intended Use: The LactoSorb® Tibial L-15 Screw and Washer is indicated for the following procedures:
1-11
574.267.8137
-
- ACL and PCL reconstruction
-
- Medial collateral ligament repair
-
- Lateral collateral ligament repair
-
- Posterior oblique ligament repair
E
574.267.6639
-
- Iliotibial band tenodesis reconstruction
-
- Patellar ligament and tendon repair
1
This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.
Summary of Technologies: The overall design, materials and processing methods are similar to the predicate device
Non-Clinical Testing: Mechanical testing demonstrated pull-out testing comparable to the predicate device.
Clinical Testing: None provided
All trademarks are property of Biomet, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus, featuring three curved lines above a wavy line.
Public Health Service
NOV = 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0578
K033233 Re:
Trade Name: LactoSorb® Tibial L-15 Screw and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI Dated: October 1, 2003 Received: October 6, 2003
Dear Ms. Beres:
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 requiréments 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 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.
3
Page 2 - Ms. Patricia Sandborn Beres
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) 594-4659. 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 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 Mulhearn
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
510(k) NUMBER (IF KNOWN):_____________________________________________________________________________________________________________________________________________________
DEVICE NAME: LactoSorb® Tibial L-15 Screw and Washer
INDICATIONS FOR USE:
The LactoSorb® Tibial L-15 Screw and Washer is indicated for the following procedures:
-
- ACL and PCL reconstruction
-
- Medial collateral ligament repair
-
- Lateral collateral ligament repair
-
- Posterior oblique ligament repair
-
- Iliotibial band tenodesis reconstruction
-
- Patellar ligament and tendon repair
This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter-Use__
(Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number
11
OR