SPS Small Fragment Set The Stryker Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following: One third tubular plate: fibula, metatarsals, metacarpals Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle Oblique T-plate: distal radius T-plate: distal radius, calcaneus, lateral clavicle Cloverleaf plate: proximal humerus, distal tibia Calcaneal plate: calcaneus Reconstructive plate: humerus, pelvis Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone. SPS 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, the tibia, the humerus and 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, the tibial plateau, the distal tibia and the proximal humerus.

Device Description

This Special 510(k) submission is a line extension to address modifications to the Stryker® Plating System (SPS), which includes the SPS Small Fragment Set, the SPS Basic Fragment Set, the SPS Pelvic Set and the Stryker Locked Plating Set. This line extension is to add additional styles of monoaxial plates based on the SPS Small Fragment Set and the SPS Basic Fragment Set.

AI/ML Overview

This document describes a Special 510(k) submission for a line extension to the Stryker® Plating System. It focuses on the substantial equivalence of the new components to existing predicate devices, rather than a study proving device performance against acceptance criteria in the traditional sense of a clinical or analytical performance study for a novel device.

Therefore, many of the requested elements for a performance study (like sample size, ground truth, expert adjudication, MRMC studies, standalone performance, and training set information) are not applicable in this context. The acceptance criteria here are about demonstrating that the modified device maintains the same safety and effectiveness as its already-cleared predicates.

Here's a breakdown based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance (Stated Equivalence)
Intended Use: The modifications to the device must not alter the intended use of the predicate systems.	"The modifications do not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject plates are provided below... The subject plates and subject accessories have the same indications as cleared their predicates."
Indications for Use: The new components must have the same indications for use as their predicates.	The document explicitly lists the indications for use for the SPS Small Fragment Set and SPS Basic Fragment Set, and states: "The subject plates and subject accessories have the same indications as cleared their predicates." This is further reiterated in the FDA's "Indications for Use" enclosure.
Substantial Equivalence (Design, Performance, Operational Principle): The new components must be substantially equivalent to their predicates in design, performance, and operational principle as internal fixation components to ensure safety and effectiveness.	"These additional monoaxial components are substantially equivalent to their predicate systems from the Stryker® Plating System in respect to design, intended use, performance and operational principle as internal fixation components." The FDA's 510(k) clearance itself is a determination that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies the FDA concurred with the applicant's assessment that the design, performance (presumably mechanical testing, biocompatibility, etc., as per similar predicate devices, though not detailed in this summary), and operational principles are equivalent.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is not a study with a test set of data in the traditional sense of evaluating an algorithm's performance on a dataset. The "test" here refers to the comparisons made to predicate devices for substantial equivalence. The data provenance would be the design and manufacturing specifications of the new components compared against those of the predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth, in the context of device performance, usually refers to a definitive diagnosis or reference standard. Here, the "ground truth" for substantial equivalence is the FDA's regulatory framework and the established safety and effectiveness profiles of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There's no specific adjudication method described for a "test set" as this is a regulatory submission demonstrating substantial equivalence, not a performance trial. The FDA's review process itself serves as the "adjudication" for the substantial equivalence claim.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is performed to evaluate the diagnostic accuracy of a medical imaging device with and without AI assistance across multiple readers and cases. This document is for a bone plating system, not an imaging device, and its purpose is to demonstrate substantial equivalence, not comparative effectiveness of human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device (bone plating system), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" implicitly used for this submission is the established regulatory compliance and performance of the predicate devices. The new components are asserted to be equivalent to these cleared devices, meaning they meet the same safety and effectiveness standards already accepted by the FDA for the predicates.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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Kobos14

Vic 11

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Summary of Safety and Effectiveness Stryker® Plating System Line Extension

Proprietary Name:	Stryker® Plating System
Common Name:	Bone Plate System
Classification Name and Reference:	Single/Multiple Component Metallic BoneFixation Appliances and Accessories, 21 CFR§888.3030
Proposed Regulatory Class:	Smooth or Threaded Metallic Bone FixationFastener, 21 CFR §888.3040Class II
Device Product Code:	87 HRS: Plate, Fixation, Bone87 HWC: Screw, Fixation, Bone
For Information contact:	Vivian Kelly, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581Fax: (201) 831-6038
Date Summary Prepared:	February 24, 2006

Description:

Intended Use

The modifications do not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject plates are provided below.

Indications

The indications for use for the predicate plates are provided below and in Appendix E. The subject plates and subject accessories have the same indications as cleared their predicates.

SPS Small Fragment Set The Stryker Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following:

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Cloverleaf plate: proximal humerus, distal tibia Calcaneal plate: calcaneus Reconstructive plate: humerus, pelvis

Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone.

SPS 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, the tibia, the humerus and 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, the tibial plateau, the distal tibia and the proximal humerus.

Substantial Equivalence:

These additional monoaxial components are substantially equivalent to their predicate systems from the Stryker® Plating System in respect to design, intended use, performance and operational principle as internal fixation components.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, topped with wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAH 17 2006

Howmedica Osteonics Corporation c/o Ms. Vivian Kelly, RAC Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K060514

Trade/Device Name: Stryker Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS. HWC Dated: February 24, 2006 Received: February 27, 2006

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 interstatc 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 (TFF 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 (240) 276-0120. 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,

Herbert Lerner wo

or Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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60514

Indications for Use

510(k) Number (if known):

Device Name: Stryker® Plating System

Indications for Use:

SPS Small Fragment Set

The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following:

One third tubular plate: fibula, metatarsals, metacarpals Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle Oblique T-plate: distal radius T-plate: distal radius, calcaneus, lateral clavicle Cloverleaf plate: proximal humerus, distal tibia Calcaneal plate: calcaneus Reconstructive plate: humerus, pelvis

Screws are used cither to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone.

SPS 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 bonc fractures including but not limited: to fractures of the femur, the tibia, the humerus and 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, the tibial plateau, the distal tibia and the proximal humerus.

Prescription Use (Part 21 CFR 801 Subpart D)	X
Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

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510(k) Number	K060514
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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.