(40 days)
Not Found
No
The summary describes a mechanical plating system for bone fixation and makes no mention of AI or ML.
No
The device is used for open reduction and internal fixation of fractures, which are surgical procedures to stabilize bones, not to treat a disease or condition in a therapeutic manner. It is a surgical implant designed to provide mechanical support rather than a biological or physiological therapeutic effect.
No
Explanation: The device is a Distal Radius Plating System, which is used for internal fixation of fractures, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components (plates and screws) made of a co-polymer, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices 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 and Intended Use: The provided information clearly describes a surgical implant system (plates and screws) used for the internal fixation of bone fractures. This is a therapeutic device, not a diagnostic one. It is used in the body to treat a condition, not to analyze samples from the body to diagnose a condition.
The device's function is to provide structural support and stability to a fractured bone, which is a direct treatment of a physical injury. It does not involve any analysis of biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Distal Radius Plating System is indicated for use in open reduction and internal fixation of Frykman type I-IV dorsally displaced Colles fractures, intomies, and carpal fusions of the distal radius in the presence of appropriate immobilization.
Product codes
HRS
Device Description
The Distal Radius Plating System consists of resorbable dorsal and volates. The plates are used in conjunction with 2.5mm resorbable screws. The plates and screws are made of a L-lactide/glycolide co-polymer.
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: In-vitro mechanical testing was completed and demonstrated that the Distal Radius Plating System was equivalent to the predicate devices.
Clinical Testing: No clinical data was completed.
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 2 2 2002
ARTERS CORPORA
Summary of Safety and Effectiveness
| Applicant or Sponsor: | Biomet, Inc.
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|-----------------------|------------------------------------------------------------|
| Contact Person: | Michelle L. McKinley
Regulatory Specialist |
| Proprietary Name: | Distal Radius Plating System |
| Common or Usual Name: | plate system |
| Classification Name: | Plate, fixation, bone (888.3030); |
| Device Product Code: | HRS |
Substantially Equivalent Device(s): Bionx Biodegradable Threaded Distal Radius Screw (K974876) , Resorbable Bone Pins (K011522)
Device Description: The Distal Radius Plating System consists of resorbable dorsal and volates. The plates are used in conjunction with 2.5mm resorbable screws. The plates and screws are made of a L-lactide/glycolide co-polymer.
Intended Use: The Distal Radius Plating System is indicated for use in open reduction and internal fixation of Frykman I-IV dorsally displaced Colles fractures, osteotomies, and carpal fusions of the distal radius in the presence of appropriate immobilization.
Summary of Technologies: Extensive testing determined that the Distal Radius Plating System and Bionx Biodegradable Threaded Distal Radius Screw have equivalent mechanical properties. Biocompatibility testing was completed and demonstrated that the co-polymer material is non-toxic, non-mutagenic, and non-pyrogenic,
Non-clinical Testing: In-vitro mechanical testing was completed and demonstrated that the Distal Radius Plating System was equivalent to the predicate devices.
Clinical Testing: No clinical data was completed.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
1
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
1
OFFICE 219.267.6639
I·AX 219.267.8137
E-MAIL biomet@biomet.com
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing left. The eagle is composed of three thick, curved lines that suggest feathers.
Public Health Service
APR 2 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Verstynen Biomet, Inc. P.O. Box 587 Warsaw, IN 46581-0587
Re: K020819
Trade/Device Name: Distal Radius Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 31, 2002 Received: March 13, 2002
Dear Ms. Verstynen:
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.
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.
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Page 2 -- Ms. Mary Verstynen
This letter will allow you to begin marketing your device as described in your Section 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 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" (21 CFR 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 vours.
Mark McMullen
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
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|---|---|---|
510(k) Number (IF KNOWN): __K020819
Device Name: Distal Radius Plating System
Indications for Use:
The Distal Radius Plating System is indicated for use in open reduction and internal fixation of Frykman type I-IV dorsally displaced Colles fractures, intomies, and carpal fusions of the distal radius in the presence of appropriate immobilization.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-the-Counter Use Prescription Use A (Optional Format 1-2-96) (Per 21 CFR 801.109)
ision Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020819