Reconstruction plates, wide and narrow straight and waisted compression-plates are indicated for fixation of long bone fractures including but not limited to:

Fractures of the femur .
Fractures of the tibia .
Fractures of the humerus .
Fractures of the pelvis .

T-Plates, T-buttress Plates and L-buttress-Plates are indicated for fractures at the proximal or distal end of long bones including but not limited to:

Fractures of the femoral condyles .
Fractures of the tibial plateau .
Fractures of the distal tibia .
Fractures of the proximal-humerus ●

Device Description

The Basic Fragment Set is part of the Stryker Plating System. The Basic Fragment Set is consists of plates and screws for the fixation of fractures of the cortical and metaphyseal area of long bones as well as fractures of the pelvis. The implant set is available either in stainless steel (316L) or titanium alloy (Ti6Al4V).

AI/ML Overview

This document is a 510(k) summary for the Stryker Plating System Basic Fragment Set, submitted to the FDA in 2001. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided text.

Here is a breakdown of the requested information based on the provided text:

Table of acceptance criteria and the reported device performance
- Not Applicable. The document is a 510(k) summary demonstrating substantial equivalence, not a performance study with defined acceptance criteria and reported device performance metrics in the way these terms are typically used for diagnostic or AI devices. The substantial equivalence is based on similarities in intended use, materials, and design to other currently marketed plating systems.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or data provenance is mentioned as this is not a clinical performance study. The substantial equivalence analysis does not involve a "test set" in this context.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth establishment by experts is not relevant to this 510(k) submission, which focuses on substantial equivalence based on design and materials.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
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
- Not Applicable. This is a hardware device (bone plate system), not an AI or diagnostic device that would undergo an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device, so a standalone algorithm performance study is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. Ground truth, in the context of clinical studies for AI or diagnostic devices, is not a concept applied to this type of device submission.
The sample size for the training set
- Not Applicable. There is no "training set" as this is not a device employing machine learning or AI.
How the ground truth for the training set was established
- Not Applicable. As no training set exists, ground truth establishment for it is not applicable.

Summary

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

Basic Fragment Set

AUG 3 1 2001

K012162

510(k) Summary of Safety and Effectiveness for the Basic Fragment Set

Proprietary Name:	Stryker Plating System Basic Fragment Set
Common Name:	Bone Plate System
Classification Name and Reference	21 CFR §888.3030 and 21 CFR §888.3040
Regulatory Class:	Class II
For Information contact:	Karen Ariemma, Regulatory Affairs Specialist
	Howmedica Osteonics Corp.
	59 Route 17
	Allendale, NJ 07401-1677
	Phone: (201) 760-8187
	Fax: (201) 760-8435
Date Summary Prepared:	July 10, 2001

Intended Use:

The Basic Fragment Set is intended for use in long bone fracture fixation.

Description:

Substantial Equivalence:

Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed plating systems. Analysis has been conducted demonstrating substantial equivalence to a currently marked device.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Public Health Service

AUG 3 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corportion 59 Route 17 Allendale, New Jersey 07401-1677

Re: K012162

Trade Name: Basic Fragment Set Regulation Number: 888.3030 Regulatory Class: II Product Codes: HRS, HWC Dated: July 10, 2001 Received: July 11, 2001

Dear Ms. Ariemma:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed from we free is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce suice in also 28, 1976, the enactment date of the Medical Device Amendments, or to devices that provisions of the in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Coorisions 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket rippt of ally in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspoticils) also I GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2 - Ms. Karen Ariemma

This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotter will and in your you substantial equivalence of your device to a legally marketed nouticate 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 If you desire specific as in vitro diagnostic devices), please contact the Office of Compliance at additionally, for questions on the promotion and advertising of your device, (2017) 594-4639. Nathiendry, commission (301) 594-4639. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation on your responsibility free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

b. Mark A. Milkersen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

{3}------------------------------------------------

510(k) Number (if known): Ko 2(6 س2

Device Name: Basic Fragment Set

The Basic Fragment Set is intended for use in long bone fracture fixation.

Reconstruction plates, wide and narrow straight and waisted compression-plates are indicated for fixation of long bone fractures including but not limited to:

Fractures of the femur .
Fractures of the tibia .
Fractures of the humerus .
Fractures of the pelvis .

T-Plates, T-buttress Plates and L-buttress-Plates are indicated for fractures at the proximal or distal end of long bones including but not limited to:

Fractures of the femoral condyles .
Fractures of the tibial plateau .
Fractures of the distal tibia .
Fractures of the proximal-humerus ●

fo Mark n Millkerson

al. Restorative

2012160 510(k) Number_

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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.