The 3.5mm and 4.5mm proximal tibial Periarticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the tibia. The 4.5mm distal femur Periaticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the femur.

Device Description

This Special 510(k) submission is intended to address a line extension to the predicate SPS Small Fragment Set and SPS Basic Fragment Set which are both part of the Stryker Plating System. Both the SPS Small Fragment Set and SPS Basic Fragment Set consist of plates and screws for the fixation of fractures of the cortical and metaphyseal areas of long bones as well as fractures of the pelvis. There is no change in intended use for the modified device when compared to the previously cleared devices. The line extension involves offering a new Periarticular Plate version for the fixation of fractures of the cortical and metaphyseal regions of long bones. Howmedica Osteonics intends to add the new components to the current product line, thereby offering additional design options for the surgeon. The Periarticular Plates will be available in stainless steel (316L).

AI/ML Overview

The provided document describes a Special 510(k) Premarket Notification for a line extension to the Stryker Plating System, specifically involving 3.5mm and 4.5mm Periarticular Plates. This submission is for a medical device (bone plates) and not an AI/ML powered medical device. Therefore, many of the typical acceptance criteria and study components related to AI/ML performance (like sample sizes for test and training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable here.

However, I can extract information related to the device's functional equivalence based on the provided text.

Acceptance Criteria and Device Performance

Acceptance Criterion	Reported Device Performance (or Mechanism for Demonstrating Equivalence)
Intended Use	The Periarticular Plates are intended for use in long bone fracture fixation. This matches the intended use of the predicate SPS Small Fragment Set and SPS Basic Fragment Set.
Materials	The Periarticular Plates will be available in stainless steel (316L), which aligns with common materials used in bone plating systems and likely matches the predicate devices.
Design	Similarities in design to other currently marketed plating systems, specifically the predicate SPS Small Fragment Set and SPS Basic Fragment Set.
Mechanical Properties	FEA (Finite Element Analysis) demonstrates comparable mechanical properties of the subject Periarticular Plates and the predicate SPS Basic Fragment Set.
Regulatory Classification	Class II, consistent with Single/Multiple Component Metallic Bone Fixation Appliances and Accessories (21 CFR §888.3030) and Smooth or Threaded Metallic Bone Fixation Fastener (21 CFR §888.3040).

Study Information (as applicable to a physical medical device submission)

Sample size used for the test set and the data provenance: Not applicable. This submission is for a physical device, and the "study" primarily consists of engineering analyses (FEA) and comparison to predicate devices, not data from a patient test set in the traditional sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical properties is typically established through engineering standards, material testing, and computational modeling, not by expert consensus on clinical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/ML-powered device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML-powered device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical properties, the "ground truth" would be established by engineering principles, accepted material standards, and results from a validated Finite Element Analysis (FEA) model. The comparison is against the mechanical properties of a predicate device.
The sample size for the training set: Not applicable. This involves a physical device and engineering analysis, not a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary of the Study (Demonstration of Substantial Equivalence):

The "study" in this context is a demonstration of substantial equivalence to existing legally marketed predicate devices, as required for a 510(k) submission.

Methodology: The submission relies on Finite Element Analysis (FEA) to compare the mechanical properties of the proposed Periarticular Plates with those of the predicate SPS Basic Fragment Set.
Basis for Equivalence: Equivalency is based on similarities in:
- Intended Use: "long bone fracture fixation" remains unchanged from the predicate devices.
- Materials: Use of 316L stainless steel.
- Design: Comparison to other currently marketed plating systems, specifically the predicate SPS Basic Fragment Set.
Conclusion: The FEA analysis "demonstrates the comparable mechanical properties" of the new plates and the predicate, supporting the claim of substantial equivalence. This allows the new components to be added to the product line as a "line extension."

In essence, for this type of medical device submission, the "study" is an engineering validation and comparative analysis to a predicate device, rather than a clinical trial or performance study involving patient data or AI algorithms.

Summary

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Line Extension to the SPS Small Fragment Set and SPS Basic Fragment Set - 3.5mm and 4.5mm Periarticular Plates

Special 510(k) Premarket Notification

JUL 2 5 2003

Special 510(k) Summary of Safety and Effectiveness: Line Extension t Fragment Set and SPS Basic Fragment Set - 3.5mm and 4.5mm Periarticular Plates

Submission Information

	Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp.59 Route 17 SouthAllendale, NJ 07401-1677
	Contact Person:	Vivian KellyRegulatory Affairs ConsultantPhone: 201-831-5581Fax: 201-831-6038
	Date of Summary Preparation:	June 18, 2003
	Device Identification
	Proprietary Name:	Stryker Plating System Periarticular Plates
	Common Name:	Bone Plate System
	Classification Name and Reference:	Single/Multiple Component Metallic Bone FixationAppliances and Accessories, 21 CFR §888.3030Smooth or Threaded Metallic Bone FixationFastener, 21 CFR §888.3040

Regulatory Class:

Description

Class II

Intended Use

The Periarticular Plates are intended for use in long bone fracture fixation.

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 marketed device.

Statement of Technological Comparison

FEA analysis demonstrates the comparable mechanical properties of the subject Periarticular Plates and predicate SPS Basic Fragment Set.

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Line Extension to the SPS Small Fragment Set and SPS Basic Fragment Set - 3.5mm and 4.5mm Periarticular Plates

Special 510(k) Premarket Notification

Device Identification

KO31959
page 2 of 2

Proprietary Name:

Stryker Plating System Periarticular Plates

Common Name:

Bone Plate System

Class II

Classification Name and Reference:

Single/Multiple Component Metallic Bone Fixation Appliances and Accessories, 21 CFR §888.3030

Smooth or Threaded Metallic Bone Fixation Fastener, 21 CFR §888.3040

Proposed Regulatory Class:

Device Panel/Product Code:

87 HRS: Plate, Fixation, Bone 87 HWC: Screw, Fixation, Bone

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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.

JUL 25 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Vivian Kelly Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Re: K031959

Trade/Device Name: Stryker Plating System Periarticular Plates Regulation Number: 21 CFR 3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: June 18, 2003 Received: June 25, 2003

Dear Ms. Kelly:

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

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Page 2 - Ms. Vivian Kelly

forth in the quality systems (OS) 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.

to Mark A. Milkerson

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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Page 1 of 1

510(k) Number (if known): K031959

Device Name: 3.5mm and 4.5mm Periarticular Plates

Indications For Use:

The 3.5mm and 4.5mm Periarticular Plate components are intended for use in long bone fracture fixation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Optional Format 1-2-96)

(Per 21 CFR 801.109)

Ad. Mem.

vision of General. Restorative and Neurological Devices

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.