TEXAS T - PLATE

• K Number: K031334
• Device Name: TEXAS T - PLATE
• Manufacturer: BIOMET, INC.
• Date Cleared: 2003-05-22 ( 24 days)
• Product Code: HRS , HWC
• Regulation Number: 888.3030
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended 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.

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.

AI/ML Overview

The provided text describes the Biomet Texas T-Plate, a device used for internal fixation of distal radius fractures. The primary evidence presented for its acceptance is a "Non-Clinical cantilever bending test."

Here's an analysis of the acceptance criteria and the study as per your request, based only on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Sustain a load during cantilever bending test	Able to sustain a higher load than either the IQL Small Epiphysis Plate or the IQL T-Plate (predicate devices)

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided text. The text only mentions "the Texas T -- Plate device" (singular) and the predicate devices (also singular descriptions: "either the IQL Small Epiphysis Plate or the IQL T - Plate"). It's likely a small number of physical samples were tested, but the exact count is not given.
   • Data Provenance: The study was a "Non-Clinical" test. No information is provided regarding the country of origin of the data. It's a laboratory test, not patient data, so "retrospective or prospective" is not applicable in the usual clinical sense.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This was a non-clinical, mechanical bending test. "Ground truth" in this context would be the measured load sustained before failure, which is determined by instrumentation, not expert consensus.

3. Adjudication method for the test set:

   • Not applicable. As a mechanical test, the results are objectively measured.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a non-clinical mechanical test of a bone plate, not an AI-assisted diagnostic or treatment device involving human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used:

   • The "ground truth" for this non-clinical test would be the direct measurement of load sustained during a cantilever bending test, likely measured by specialized mechanical testing equipment.

7. The sample size for the training set:

   • Not applicable. This is a non-clinical mechanical test, not a machine learning study that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

Summary of the Study:

The "study" described is a Non-Clinical cantilever bending test. Its purpose was to compare the mechanical strength (specifically, the ability to sustain a load) of the Texas T-Plate against two legally marketed predicate devices: the IQL Small Epiphysis Plate and the IQL T-Plate. The test found that the Texas T-Plate was able to sustain a higher load than both predicate devices, indicating superior mechanical performance in this specific test. This type of non-clinical data is commonly used for Class II surgical implants to demonstrate substantial equivalence in performance characteristics.

Summary

{0}------------------------------------------------

BIOMET

K0 31334
page 1 of 2

Summary of Safety and Effectiveness

Applicant or Sponsor:	Biomet, Inc.56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0578
-----------------------	----------------------------------------------------------------------------------

Contact Person: Gary Baker Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0578 Phone: [phone] FAX: [phone]

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 [phone]

E-MAIL [e-mail]

{1}------------------------------------------------

3/334
page 2 of 2

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 [phone]. 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 [phone] or [phone] 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_

Regulation Number and Section

§ 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.