(75 days)
Not Found
Not Found
No
The device description focuses solely on the mechanical components (plates, screws, pins) and materials used for fracture fixation. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML.
No
The device is a distal radial plate system used for fixation of fractures, not for treating diseases or conditions directly.
No
The device, the LoCon-T Distal Radial Plate System, is described as a system for fixation of distal radius fractures, including plates, screws, and pins. Its purpose is to physically stabilize bone fragments, not to diagnose medical conditions. The "Intended Use" section clearly states its role in "fixation of unstable distal radius fractures."
No
The device description explicitly lists hardware components such as plates, screws, and pins made of stainless steel, which are physical implants used in surgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of unstable distal radius fractures. This is a surgical procedure performed directly on the patient's body to stabilize bone fragments.
- Device Description: The device is described as a system of plates, screws, and pins made of stainless steel. These are all components used in orthopedic surgery for internal fixation of bones.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a surgical implant used for orthopedic fixation, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Use of the LoCon-T Distal Radial Plate System is intended to be used for fixation of unstable distal radius fractures in which closed reduction is not suitable:
- Joint destruction and/or subluxation visible on x-ray; .
- Failed fracture fixation with or without bone graft; ●
- Osteotomy and repair of distal radius malunion with or without . bone graft;
- Displaced or non-displaced fracture which may or may not involve . angulation or fragmentation of bone;
- Dorsal plates are indicated for use with comminuted articular . fractures, shearing fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator; or
- T-plates are indicated for use with volar articular shearing . fractures
Product codes
HRS
Device Description
The LoCon-T Distal Radial Plate System includes four side specific dorsal plate, one volar T-plate, a dorsal plate extender, cortical screws, cancellous screws, and buttress pins. The plates and plate extender are manufactured from Stainless Steel (ASTM F 139). The screws are manufactured from Stainless Steel (ASTM F 138). The pins are manufactured from Stainless Steel (ASTM F 1314). The plates, pins, extender, and screws are designed to be lower in profile and secure bone fragments. The dorsal plates are available in two sizes for both right and left configurations. The cancellous screws are available in partially and fully threaded 4.0mm diameter designs ranging in length from 10.0 to 40.0mm in 2.0mm increments. The cortical screws are available in 3 diameters. The pins are 1.8mm in diameter and range in length from 12mm to 30mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
distal radius
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
Mechanical test data demonstrated that the material and subject device design meets the strength requirements of the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Zimmer Forte Distal Radial Plate System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FFB 1 4 2000
Image /page/0/Picture/2 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" on the left, followed by the company name in bold, uppercase letters. Below the name is the company's address: 5677 Airline Road, Arlington, TN 38002, and their phone number: 901-867-9971.
510K Summary
Company: Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 Date: November 30, 1999 Trade Name: LoCon-TTM Distal Radial Plate System Common Name: Metallic Bone Fixation System Predicate Device: Zimmer Forte Distal Radial Plate System
Description/Intended Use:
The LoCon-T Distal Radial Plate System includes four side specific dorsal plate, one volar T-plate, a dorsal plate extender, cortical screws, cancellous screws, and buttress pins. The plates and plate extender are manufactured from Stainless Steel (ASTM F 139). The screws are manufactured from Stainless Steel (ASTM F 138). The pins are manufactured from Stainless Steel (ASTM F 1314). The plates, pins, extender, and screws are designed to be lower in profile and secure bone fragments. The dorsal plates are available in two sizes for both right and left configurations. The cancellous screws are available in partially and fully threaded 4.0mm diameter designs ranging in length from 10.0 to 40.0mm in 2.0mm increments. The cortical screws are available in 3 diameters. The pins are 1.8mm in diameter and range in length from 12mm to 30mm.
Intended Use:
Use of the LoCon-T Distal Radial Plate System is intended to be used for fixation of unstable distal radius fractures in which closed reduction is not suitable:
- Joint destruction and/or subluxation visible on x-ray; .
- Failed fracture fixation with or without bone graft; .
- Osteotomy and repair of distal radius malunion with or without bone . graft;
- Displaced or non-displaced fracture which may or may not involve . angulation or fragmentation of bone;
- Dorsal plates are indicated for use with comminuted articular fractures, . shearing fractures of the articular surface, severely comminuted extraarticular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator; or
- T-plates are indicated for use with volar articular shearing fractures
Testing Summary:
The LoCon-T Distal Radial Plate System was declared substantially equivalent to the predicate devices. Mechanical test data demonstrated that the material and subject device design meets the strength requirements of the predicate device.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2000
Ms. Lynne Witkowski Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K994061 Trade Name: LoCon-T™ Distal Radial Plate System Regulatory Class: II Product Code: HRS Dated: November 30, 1999 Received: December 1, 1999
Dear Ms. Witkowski:
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 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.
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.
2
Page 2 - Ms. Lynne Witkowski
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.
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) 594-4595. 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil RP Ogden
James E. Dillard III
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| 510(k) Number (if known) | K994061 |
|---|---|
| Device Name | LoCon-T Distal Radial Plate System |
| Indications for Use |
Intended Use
Use of the LoCon-T Distal Radial Plate System is intended for...
ystem is intended to be used for fixation of unstable distal radius fractures in which closed reduction is not suitable:
Indications for Use Statement
- Joint destruction and/or subluxation visible on x-ray; .
- Failed fracture fixation with or without bone graft; ●
- Osteotomy and repair of distal radius malunion with or without . bone graft;
- Displaced or non-displaced fracture which may or may not involve . angulation or fragmentation of bone;
- Dorsal plates are indicated for use with comminuted articular . fractures, shearing fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator; or
- T-plates are indicated for use with volar articular shearing . fractures
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | NRO for J2D |
| Division of General Restorative Devices | |
| 510(k) Number | K994061 |
| Prescription Use (per 21 CFR 801.109) | X |
| OR | |
| Over-The Counter Use |