(26 days)
Not Found
No
The device description and intended use focus solely on a mechanical external fixator for bone stabilization, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for stabilization of fractures, which is a therapeutic intervention.
No
The device is an external wrist fixator used for stabilizing open and/or unstable fractures of the distal radius. Its purpose is mechanical support and stabilization, not to diagnose a condition or disease.
No
The device description clearly outlines a physical external wrist fixator made of polymer and polycarbonate, with plates, pin holes, and pins for fracture stabilization. This is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that this device is an external wrist fixator. It is a physical device used to stabilize bone fractures.
- Intended Use: The intended use is to stabilize fractures of the distal radius. This is a therapeutic use, not a diagnostic one.
- Lack of Diagnostic Elements: The description does not mention any testing of biological samples, analysis of bodily fluids, or any other activity related to diagnosing a condition.
This device falls under the category of surgical or orthopedic devices used for fracture management.
N/A
Intended Use / Indications for Use
Stabilization of open and/or unstable fractures of the distal radius, where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.
Product codes
LXT
Device Description
The device is an external wrist fixator made of radiolucent polymer, polycarbonate. The fixator is a non-bridging device, which means that it does not cross the wrist. A non-bridging device gives patients the ability to utilize wrist function.
The device consists of two plates with multiple pin holes. Pins are inserted through the plates, into the bone and held in place by the interference of the two plates. The plate has an external bracket that allows pins to be inserted from the side for additional fixation. If desired, distraction of the fracture site may be achieved with adjustment of a threaded pin placed within a slot on the distal end of the plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Non-Clinical Testing: Mechanical testing was conducted to insure the design changes would not effect the safety of the 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
§ 888.3030 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
APR 1 5 2002
K020905
page 1 of 1
ARTERS CORPORATE
Summary of Safety and Effectiveness
| Applicant/Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|--------------------|------------------------------------------------------------------------|
| Contact Person: | Patricia Sandhorn Beres |
Senior Regulatory Specialist Phone: (574) 267-6639
Proprietary Name: NBX - Non-Bridging External Fixator
Common Name: External Fixator
Classification Name: Single/Multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030)
Legally Marketed Device to which Substantial Equivalence is Claimed: Biomet External Wrist Plate (K003240)
Device Description: The device is an external wrist fixator made of radiolucent polymer, polycarbonate. The fixator is a non-bridging device, which means that it does not cross the wrist. A non-bridging device gives patients the ability to utilize wrist function.
The device consists of two plates with multiple pin holes. Pins are inserted through the plates, into the bone and held in place by the interference of the two plates. The plate has an external bracket that allows pins to be inserted from the side for additional fixation. If desired, distraction of the fracture site may be achieved with adjustment of a threaded pin placed within a slot on the distal end of the plate.
Intended Use: Stabilization of open and/or unstable fractures of the distal radius, where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.
Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the NBX – Non-Bridging External Fixator are similar to or identical to the predicate device.
Non-Clinical Testing: Mechanical testing was conducted to insure the design changes would not effect the safety of the device.
Clinical Testing: None provided
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
행
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
OFFICE 219.267.6639
ドヘX 219.267.8137
E-MAH biomet@biomet.com
00081
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 2002
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587
Re: K020905
Trade/Device Name: NBX-Non-Bridging External Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories.
Regulatory Class: II Product Code: LXT Dated: March 19, 2002 Received: March 20, 2002
Dear Ms. Beres:
We have reviewed your Section 510(k) premarket notification of intent to market the device wone reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are and and 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.
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.
2
Page 2 - Ms. Patricia Sandborn Beres
This letter will allow you to begin marketing your device as described in your Section 510(k) I mir letter hititication. 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
for Mark n Millican
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
3
510(k) Number (if known): K020905
Device Name: NBX - Non-Bridging External Fixator
Indications For Use:
Stabilization of open and/or unstable fractures of the distal radius, where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.
for Mark n Millkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KO20905 510(k) Number ________________________________________________________________________________________________________________________________________________________________
(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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
000005