(64 days)
Not Found
No
The summary describes a mechanical device (screws and washers) for orthopedic fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for ligament and tendon repair and reconstruction, which are therapeutic procedures.
No
The device is a nonresorbable screw and washer system intended for soft tissue fixation to bone in ligament repair and reconstruction, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a series of tibial screws and washers, which are physical hardware components, 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 surgical procedures involving the repair and reconstruction of ligaments and tendons in the knee. This is a direct surgical intervention on the patient's body.
- Device Description: The device is described as a screw and washer designed for soft tissue fixation to bone. This is a physical implant used during surgery.
- 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 outside the body to analyze samples and provide diagnostic information. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
The tibial screws and washers are indicated for the following procedures: lar screws and wasners are merceach (ACL) and posterior cruciate ligament (PCL) reconstruction Medial collateral ligament repair 2. 3. Lateral collateral ligament repair 115 SHIPPING ADDRESS MAILING ADDRESS 56 E. Bell Drive 120. Box 587 Warsaw, IN 46582 Warsaw, IN 46581-0587 E-MAIL FAX . ()FFICE 트 biomet@biomet.com 574.267.8137 574.267.6639
-
- Posterior oblique ligament repair
- Iliotibial band tenodesis reconstruction 5.
- Patellar ligament and tendon repair 6.
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 (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The Nonresorbable CentraLoo™ Tibial Screws and Washers are a series of the seconding the Same of Sation of Sation to hans Device Deseription: - Ins designed for soft tissue fixation to bone.
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: Mechanical testing found the Nonresorbable CentraLoc™ Tibial Screw and Washer to be substantially equivalent to the predicate No Profile Lactosorb® L-15 Screw and Washer devices for the uses intended.
Clinical Testing: Clinical testing was not necessary to determine substantial equivalence for the Nonresorbable CentraLoc™ Tibial Screw and Washer.
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.
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
KOS1069
JUN 2 9 2005
Image /page/0/Picture/2 description: The image shows the word "BIOMET" in a stylized, bold, sans-serif font. Each letter is outlined with a thick black border, giving the word a blocky and modern appearance. The letters are tightly spaced, creating a compact and unified design.
510(k) Summary
| Applicant/Sponsor: | Arthrotek. Inc.
(A wholly owned subsidiary of Biomet, Inc.)
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Baker
Biomet Manufacturing Corp.
P.O. Box 587
Warsaw, Indiana 46581-0587
Phone: (574) 267-6639
FAX: (574) 372-1683 |
| Proprietary Name: | Nonresorbable CentraLoc™ Tibial Screw and Washer |
| Common Name: | Tibial screw and washer |
| Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue. (21 CFR
§888.3040) |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
LactoSorb® Tibial L-15 Screw and Washer – Arthrotek Inc. (K033233) LactoSorb - Tiblar L-15 Screw and Washer - Arthrotek İnc. (K021832) STALIF TT – Surgicraft Ltd. (K041617)
Device Description: The Nonresorbable CentraLoo™ Tibial Screws and Washers are a series of
the seconding the Same of Sation of Sation to hans Device Deseription: - Ins designed for soft tissue fixation to bone.
Intended Use:
The tibial screws and washers are indicated for the following procedures: lar screws and wasners are merceach (ACL) and posterior cruciate ligament (PCL) reconstruction Medial collateral ligament repair 2. 3. Lateral collateral ligament repair 115 SHIPPING ADDRESS MAILING ADDRESS 56 E. Bell Drive 120. Box 587 Warsaw, IN 46582 Warsaw, IN 46581-0587 E-MAIL FAX . ()FFICE 트 biomet@biomet.com 574.267.8137 574.267.6639
1
-
- Posterior oblique ligament repair
- Iliotibial band tenodesis reconstruction 5.
- Patellar ligament and tendon repair 6.
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 Nonresorbable CentraLoc™ Tibial Screws and Washers have the same intended use and indications for use as the predicate Lactosorb® Tibial L-15 Screw and Washer and No Profile Lactosorb® L-15 Screw and Washer devices. The mechanical design is similar to the predicate resorbable devices.
Non-Clinical Testing: Mechanical testing found the Nonresorbable CentraLoc™ Tibial Screw and Washer to be substantially equivalent to the predicate No Profile Lactosorb® L-15 Screw and Washer devices for the uses intended.
Clinical Testing: Clinical testing was not necessary to determine substantial equivalence for the Nonresorbable CentraLoc™ Tibial Screw and Washer.
All trademarks are property of Biomet, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
JUN 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arthrotek, Inc. C/o Mr. Gary Baker Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K051069
K031007
Trade/Device Name: Nonresorbable CentraLoc™ Tibial Screw and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, HWC Dated: April 25, 2005 Received: April 26, 2005
Dear Mr. Baker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became re(i) fee device is substantially equivalent (for the indications felerenced above and nave actering as a losses and the same of the marketed in interstate for use stated in the encrosary w regars and ment date of the Medical Device Amendments, or to commence pror to May 20, 1978, the ensordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not requent of the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of gencial controls provisions of the tice, 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 If your device is classified (soc above) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Gods incements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not meant 1 icase be advised that i Dri brisan that your device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must of ally it cachates and regulations and aincluding, but not limited to: registration and listing (21 Comply with an the Aot 8 requirements, and manufacturing practice requirements as set CFN in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Mr. Gary Baker
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin maxing of substantial equivalence of your device to a legally premarket notheadon: "The PDF intellig sification 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 If you desire specific advice for your as (240) 276-__. Also, please note the regulation entitled, Collider the Office of Compunise market notification" (21CFR Part 807.97). You may obtain Misoranting of Telefone to prenantonibilities under the Act from the Division of Small other general information on your respense Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octoss http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Stupt Rurds
Rt. Miriam C. Provost, Ph.D.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Page 1 of 1
0(k) Number (if known):_______________________________________________________________________________________________________________________________________________________
evice Name: Nonresorbable CentraLoc™ Tibial Screw and Washer
dications For Use:
-
- Anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction
- Medial collateral ligament repair 2.
-
- 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.
escription Use X art 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 EEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hipt Lurdes
Division of General, Restorative, and Neurological Devices
510(k) Number K051069