(434 days)
Not Found
No
The device description focuses on the materials and physical dimensions of screws and washers for surgical fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a system of screws and washers used for soft tissue fixation to bone during ligament reconstructive procedures. While it's used in a medical context, it's a mechanical fixation device, not one that directly provides therapy or treatment for a disease or condition in the way that "therapeutic device" typically implies (e.g., drug delivery, pain relief, or active healing assistance). It's a surgical implant to aid in the mechanical repair of tissue.
No
This device is a surgical implant used for soft tissue fixation, specifically during ligament reconstructive procedures, not for diagnosing medical conditions.
No
The device description explicitly states it includes titanium alloy screws and washers, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Soft tissue fixation to bone, specifically during ligament reconstructive procedures." This describes a surgical procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as screws and washers made of titanium alloy, designed for physical fixation within the body. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The WasherLoc™ and No-Profile Screw and Washer Systems include titanium alloy (Ti-6Al-4V) screws and washers in various lengths and sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 30mm to 70mm are available, with washer sizes in 14mm, 16mm, and 18mm diameters with and without spikes.
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)
The WasherLoc™ and No-Profile Screw and Washer Systems have been evaluated for the effects of magnetic resonance (MR) and deemed MR Conditional.
The results of the MR evaluation indicated that the devices are MR Conditional.
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
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | ||
|---|---|---|
| Name | Biomet Sports Medicine | |
| Address | 56 East Bell Drive | |
| P.O. Box 587 | ||
| Warsaw, IN 46581-0857 | ||
| Phone number | (574) 267-6639 | |
| Fax number | (574) 372-1718 | |
| Establishment | 1825034 | |
| Registration Number | ||
| Name of contact person | Elizabeth Wray / Senior Regulatory Affairs Specialist | |
| Date prepared | August 7, 2012 | |
| Name of device | ||
| Trade or proprietary | ||
| name | WasherLoc™ and No-Profile Screw and Washer Systems | |
| Common or usual | ||
| name | Soft Tissue Fixation Devices | |
| Classification name | Fastener, fixation, nondegradable, soft tissue and smooth or | |
| threaded metallic bone fixation fastener | ||
| Classification panel | Orthopedic | |
| Regulation | 888.3040 | |
| Product Code(s) | MBI or HWC | |
| Legally marketed device(s) | ||
| to which equivalence is | ||
| claimed | WasherLoc™, Ligament Washer, Lo-Profile™, Heckman™, and | |
| Channel Ligament Screw Systems - Biomet Sports Medicine | ||
| K981967 | ||
| Cancellous Fixation Screw & Washer - Concept Inc., K871037 | ||
| Reason for 510(k) | ||
| submission | Addition of magnetic resonance (MR) compatibility language to | |
| the product labeling. | ||
| Device description | The WasherLoc™ and No-Profile Screw and Washer Systems | |
| include titanium alloy (Ti-6Al-4V) screws and washers in various | ||
| lengths and sizes. Both 4.5mm and 6.0mm diameter screws in | ||
| lengths from 30mm to 70mm are available, with washer sizes in | ||
| 14mm, 16mm, and 18mm diameters with and without spikes. | ||
| Intended use of the device | Soft Tissue Fixation | |
| Indications for use | Soft tissue fixation to bone, specifically during ligament | |
| reconstructive procedures. | ||
| Summary of the technological characteristics of the device compared to the predicate | ||
| Characteristic | WasherLoc™ and No-Profile | |
| Screw and Washer Systems | ||
| (Modified Device) | Predicate - WasherLoc™, | |
| Ligament Washer, Lo-Profile™, | ||
| Heckman™, and Channel | ||
| Ligament Screw Systems | ||
| (K981967) | ||
| Material | Titanium Alloy (Ti-6Al-4V) | K981967 |
| Magnetic Resonance | ||
| Information | MR Conditional | Not evaluated |
| PERFORMANCE DATA | ||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF | ||
| SUBSTANTIAL EQUIVALENCE | ||
| Summary of Technologies | ||
| The WasherLoc™ and No-Profile Screw and Washer Systems have been evaluated for the effects | ||
| of magnetic resonance (MR) and deemed MR Conditional. | ||
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL | ||
| EQUIVALENCE AND/OR OF CLINICAL INFORMATION | ||
| None provided as a basis for substantial equivalence. |
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CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
·
The results of the MR evaluation indicated that the devices are MR Conditional.
All trademarks are the property of Biomet, Inc.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like shapes, representing the department's mission related to health and human well-being.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Flealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
October 18, 2013
Biomet Sports Medicine Ms. Elizabeth Wray Senior Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581
Rc: K122437
Trade/Device Name: WasherLoc" and No-Profile Screw and Washer Systems Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: October 8, 2013 Received: October 9, 2013
Dear Ms. Wray:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Elizabeth Wray
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/gefault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincercly yours,
Mark N: Melkerson -S
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K122437
Device Name: WasherLoc™ and No-Profile Screw and Washer Systems
Indications For Use:
Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ NO (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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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