(24 days)
K 962616, K 020221
Not Found
No
The summary describes a mechanical plating system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is an orthopedic implant for internal fixation of distal radius fractures, which is a surgical device, not a therapeutic device in the sense of delivering therapy (e.g., drug delivery, radiation therapy, or other active treatment beyond providing structural support for healing).
No
The description indicates the device is a plating system for surgical fixation of fractures, not for diagnosing medical conditions.
No
The device description explicitly states that the components are manufactured of 316 LVM Stainless Steel, indicating a physical hardware device (a plating system).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "open reduction and internal fixation of fresh fractures, osteotomies, Arthrodesis, and revision procedures of the distal radius." This describes a surgical procedure performed directly on a patient's body to treat a physical condition (fractures, etc.).
- Device Description: The device is described as an "Anatomical Plating System" made of stainless steel, designed to be implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the human body to provide diagnostic information. This device is a surgical implant used to stabilize bone fractures.
N/A
Intended Use / Indications for Use
The Texas T – Plate Distal Radius Plating System is indicated for use in open reduction and internal fixation of fresh fractures, osteotomies, Arthrodesis, and revision procedures of the distal radius.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Texas T – Plate is an Anatomical Plating System for fractures of the distal radius. All components will be manufactured of 316 LVM Stainless Steel in accordance with ASTM F – 138 standards.
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
Orthopedic Surgeons
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)
Non-Clinical Testing: The Texas T -- Plate device was subjected to a Non-Clinical cantilever bending test wherein it was found to be able to sustain a higher load than either the IQL Small Epiphysis Plate or the IQL T - Plate that were identified as predicate devices.
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.
K 962616, K 020221
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
§ 888.3030 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
BIOMET
K0 31334
page 1 of 2
Summary of Safety and Effectiveness
| Applicant or Sponsor: | Biomet, Inc.
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581-0578 |
| ----------------------- | ---------------------------------------------------------------------------------- |
|---|
Contact Person: Gary Baker Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0578 Phone: (574) 267-6639 FAX: (574) 372-1683
Proprietary Name: Texas T - Plate
Common or Usual Name: Stainless Steel Bone Plates and Buttress Pins.
Classification Name: Plate, Fixation, Bone (21CFR 888.3030) Buttress Pin, Fixation, Bone (21CFR 888.3040) Screw, Fixation, Bone (21 CFR 888.3040)
Legally Marketed Device(s) to which Substantial Equivalence is Claimed (Predicate Devices): The Texas T - Plate System is Substantially Equivalent to the Synthes Dorsal Distal Radius Plating System (K 962616), and its components are Substantially Equivalent to those marketed by Industrias Quirurgicas de Levante S.L. (K 020221).
Device Description: The Texas T – Plate is an Anatomical Plating System for fractures of the distal radius. All components will be manufactured of 316 LVM Stainless Steel in accordance with ASTM F – 138 standards.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
OFFICE 574.267.6639
FAX 574.267.8137
E-MAIL biomet@biomet.com
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Indications for Use: The Texas T – Plate Distal Radius Plating System is indicated for use in open reduction and internal fixation of fresh fractures, osteotomies, Arthrodesis, and revision procedures of the distal radius.
Summary of Technology: This device utilizes standard technology that is commonly known by Orthopedic Surgeons. The technology utilized conforms to commonly accepted standards of practice for internal fixation of metallic bone plates.
Non-Clinical Testing: The Texas T -- Plate device was subjected to a Non-Clinical cantilever bending test wherein it was found to be able to sustain a higher load than either the IQL Small Epiphysis Plate or the IQL T - Plate that were identified as predicate devices.
2
Image /page/2/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 bird or eagle with three heads, possibly representing the department's focus on health, human services, and the USA.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 22 2003
Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corporation P.O. Box 587 Warsaw, IN 46581-0587
Re: K031334
Trade/Device Name: Texas T - Plate Regulation Number: 21 CFR 888.3030, 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS, HWC Dated: April 25, 2003 Received: April 28, 2003
Dear Mr. Baker:
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
3
Page 2 - Mr. Gary Baker
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.
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark McMillan
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
4
Page_1_of_1
510(k) Number (IF KNOWN): K031334
Device Name: Texas T - Plate
Indications for Use:
The Texas T – Plate Distal Radius Plating System is indicated for use in open reduction and internal fixation of fresh fractures, osteotomies, arthrodesis, and revision procedures of the distal radius.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-the-Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96
(Division Sign-Off)
Division of Generel, Restorative
and Neurological Devices
K03 1234
Over-the-Counter Use (Optional Format 1-2-96)
510(k) Number_