(88 days)
Not Found
No
The description focuses solely on the mechanical components and materials of a bone plating system, with no mention of software, algorithms, or data processing.
Yes
The device is intended for the fixation of fractures, treatment of mal-unions, non-unions, osteotomies, and wrist arthrodesis, which are all therapeutic interventions aimed at treating medical conditions or injuries.
No
The device is a plating system used for fixation of fractures and treatment of mal-unions and non-unions, which are therapeutic interventions, not diagnostic.
No
The device description explicitly states it is comprised of physical components like plates, screws, and pegs made of titanium or stainless steel, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The OptiLock® VL Distal Radius Plating System is a surgical implant used to fix bone fractures. It is physically implanted into the body to provide structural support.
- Intended Use: The intended use is for the fixation of bone fractures, treatment of mal-unions and non-unions, osteotomies, and wrist arthrodesis. These are all surgical procedures involving the musculoskeletal system, not the analysis of bodily specimens.
The description clearly indicates a device used within the body for structural support and fixation, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OptiLock® VL Distal Radius Plating System consists of a series of plates, screws and locking pegs that are intended for the fixation of intra-articular and extra-articular fractures involving the distal radius, ulna (and other small bones). This system is also intended for use in osteopenic bone. Specific indications include:
- Fixation of intra-articular and extra-articular fractures
- Treatment of mal-unions
- Treatment of non-unions
- Osteotomies
- Wrist arthrodesis
Product codes
HRS, HWC
Device Description
The OptiLock® VL Distal Radius Plating System is comprised of a series of anatomically contoured plates, and locking, variable angle locking and non-locking screws, as well as locking pegs intended to be used in the distal radius, ulna (and other small bones). This system may also be used in osteopenic bone. The plates are available in several styles to address the anatomy of the distal radius/ulna. The screws are available in two diameters, in locking, non-locking and variable angle locking styles. Locking pegs are also available as an option for stabilizing the plate to the bone.
The plates and screws of the OptiLock® VL Distal Radius Plating System are fabricated from titanium alloy (Ti-6Al-4V), which conforms to ASTM specification F-136, or stainless steel alloy which conforms to ASTM specification F-138 or F-139. Plates and screws fabricated from titanium alloy are anodized to color-code the different sizes to assist the surgeon with size selection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius, ulna (and other small bones)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K062494, K040908, K020221, K011335, K071184, K083694, K050512, K060514
Reference Device(s)
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K093761 (1/2)
Biomet Trauma Traditional 510(k) Premarket Notification
Image /page/0/Figure/2 description: The image shows the logo for Biomet Trauma. The word "BIOMET" is in large, bold, sans-serif font, with each letter connected to the next. Below the word "BIOMET" is the word "TRAUMA" in a smaller, sans-serif font. The logo is black and white.
MAR - 6 2010
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
2242816
Submitter:
: : |
Biomet Trauma (aka EBI, LLC) 100 Interpace Parkway Parsippany, NJ 07054
Establishment Registration Number:
Contact:
Margaret F. Crowe Regulatory Affairs Project Manager Biomet Trauma 100 Interpace Parkway Parsippany. NJ 07054 Tel .: 973-299-9300, ext. 2260 Fax: 973-257-0232 E-mail: margaret.crowe@biomet.com
| Date Prepared: | March 4, 2010 |
|---|---|
| Trade/Proprietary Name: | OptiLock® VL Distal Radius Plating System |
| Common/Usual Name: | Plates/Screws |
| Classification Name: | Single/multiple metallic bone fixation appliances and |
| accessories (21 CFR 888.3030) | |
| Screw, fixation, bone (21 CFR 888.3040) |
Device Panel/Product Code: Orthopedics HRS/HWC
Device Description:
The OptiLock® VL Distal Radius Plating System is comprised of a series of anatomically contoured plates, and locking, variable angle locking and non-locking screws, as well as locking pegs intended to be used in the distal radius, ulna (and other small bones). This system may also be used in osteopenic bone. The plates are available in several styles to address the anatomy of the distal radius/ulna. The screws are available in two diameters, in
1
Biomet Trauma Traditional 510(k) Premarket Notification
locking, non-locking and variable angle locking styles. Locking pegs are also available as an option for stabilizing the plate to the bone.
The plates and screws of the OptiLock® VL Distal Radius Plating System are fabricated from titanium alloy (Ti-6Al-4V), which conforms to ASTM specification F-136, or stainless steel alloy which conforms to ASTM specification F-138 or F-139. Plates and screws fabricated from titanium alloy are anodized to color-code the different sizes to assist the surgeon with size selection.
Indications for Use:
The OptiLock® VL Distal Radius Plating System consists of a series of plates, screws and locking pegs that are intended for the fixation of intra-articular and extra-articular fractures involving the distal radius, ulna (and other small bones). This system is also intended for use in osteopenic bone. Specific indications include:
-
- Fixation of intra-articular and extra-articular fractures
-
- Treatment of mal-unions
-
- Treatment of non-unions
-
- Osteotomies
-
- Wrist arthrodesis
Summary of Technologies:
The technological characteristics of the OptiLock® VL Distal Radius Plating System are the same, or similar to, other legally marketed predicate devices.
Substantial Equivalence:
The OptiLock® VL Distal Radius Plating System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and does not present any new issues of safety or effectiveness. Examples of predicates include: OptiLock® UE Plating System (K062494); EBI Distal Radius Plating System (K040908); IQL Basic Fragment Plate Set (K020221); Synthes Distal Radius Plating Systems (K011335, K071184 and K083694) and Stryker VariAx Distal Radius System (K050512 and K060514). Based upon the engineering analysis, the OptiLock® VL Distal Radius Plating System is substantially equivalent for its intended use to other legally marketed plate and screw systems.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Trauma (AKA EBI, LLC) % Ms. Margaret Crowe Regulatory Affairs Project Manager 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K093761
Trade/Device Name: OptiLock® VL Distal Radius Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: February 24, 2010 Received: February 25, 2010
MAR ~ 5 2010
Dear Ms. Crowe:
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, listing 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 (21
3
Page 2 - Ms. Margaret Crowe
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/default.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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ KO9376 |
Device Name: The OptiLock® VL Distal Radius Plating System consists of a series of plates and screws that are intended for the fixation of intra-articular and extra-articular fractures involving the distal radius, ulna (and other small bones). This system is also intended for use in osteopenic bone. Specific indications include:
-
- Fixation of intra-articular and extra-articular fractures
-
- Treatment of mal-unions
-
- Treatment of non-unions
-
- Osteotomies
-
- Wrist arthrodesis
Prescription Use X * (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Temperature
Janette for Nixon
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K045+61 510(k) Number ...