The Synthes (USA) 3.5 / 4.5mm LCP® Metaphyseal Plate is intended for the fixation of various long bones, excluding the femur. It is also for use in fixation of osteopenic bone and fixation of nonunions or malunions.

Device Description

The Synthes (USA) 3.5 / 4.5 mm LCP® Metaphyseal Plates are contourable to match the anatomy, have a limited contact design, and are tapered at the plate head. The 3.5 / 4.5 mm metaphyseal plates feature combination dynamic compression / locking screws holes (combi-holes). The plates in this system accept 3.5 / 4.5 mm cortex, 3.5, 4.0, & 5.0 mm locking, and 4.0 mm or 6.5 mm cancellous screws. The plate also has a 2.0 mm hole for preliminary fixation with k-wires.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (bone plate) and does not contain any information about an AI/ML device or its associated studies and acceptance criteria.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or ground truth details for an AI/ML device.

The document describes a conventional bone fixation plate and its substantial equivalence to predicate devices, focusing on materials, design, and intended use as per medical device regulations. It is not an AI/ML submission.

Summary

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

FEB 2 0 2004

K033805
page 1 of 1

Summary of Safety and Effectiveness Information 3.0

SPONSOR:	Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Lisa M. Boyle
DEVICE NAME:	Synthes (USA) 3.5 / 4.5 mm LCP® Metaphyseal Plates
CLASSIFICATION:	Class II, §888.3030 - Plate, Fixation, Bone
PREDICATE DEVICE:	Synthes (USA) Small Fragment DCL SystemSynthes (USA) Large Fragment DCL System
DEVICE DESCRIPTION:	The Synthes (USA) 3.5 / 4.5 mm LCP® Metaphyseal Plates are contourableto match the anatomy, have a limited contact design, and are tapered at theplate head. The 3.5 / 4.5 mm metaphyseal plates feature combinationdynamic compression / locking screws holes (combi-holes). The plates inthis system accept 3.5 / 4.5 mm cortex, 3.5, 4.0, & 5.0 mm locking, and 4.0mm or 6.5 mm cancellous screws. The plate also has a 2.0 mm hole forpreliminary fixation with k-wires.
INTENDED USE:	The Synthes (USA) 3.5 / 4.5mm LCP® Metaphyseal Plate is intended forthe fixation of various long bones, excluding the femur. It is also for use infixation of osteopenic bone and fixation of nonunions or malunions.
SUBSTANTIALEQUIVALENCE	Comparative information presented supports substantial equivalence.
MATERIAL:	Titanium and Stainless Steel

Confidential

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K033805

Trade/Device Name: Synthes (USA) 3.5 / 4.5mm LCP® Metaphyseal Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: December 4, 2003 Received: December 8, 2003

Dear Ms. Boyle:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beater of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfed in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prior to May 2017 7 3) in accordance with the provisions of the Federal Food, Drug, devices that have occh reactered require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mainer of the Act include requirements for annual registration, listing of general controls provisions 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 may or subject to back week Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Plcase be advised that FDA's issuance of a substantial equivalence determination does not mean r 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CHR 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. Lisa M. Boyle

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,

Mark N. Wilkerson

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}------------------------------------------------

Indications for Use Statement 2.0

510(k) Number (if known):	K033805
Device Name:	Synthes (USA) 3.5 / 4.5mm LCP® Metaphyseal Plate

Page __ 1 ______ of __________________________________________________________________________________________________________________________________________________________

Indications/Contraindications:

The Synthes (USA) 3.5 / 4.5mm LCP® Metaphyseal Plate is intended for the fixation of various longs The Synthes (USA) 2.5 / 4.5 min LCC - Mccapity scar Rate is meeting bone and fixation of nonunions or malunions.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over-The-Counter Use_
(Per 21 CFR 801.109)

for Mark N Milkusm

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

510(k) Number K033805

Confidential

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.