The SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The SPS Monoaxial Locking Plates are indicated for fixation of long long fractures including but not limited to fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.

Device Description

This Special 510(k) submission is intended to address modifications to the predicate Stryker Plating System. The subject and predicate devices are internal fixation plates, screws and accessories of the r no basyon attryker Locked Plating System is intended for use in long bone fracture fixation. The byeten. The Bujates are indicated for fixation of long bone fractures including but not limited to fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.

AI/ML Overview

The provided text describes a Special 510(k) submission for the Stryker Locked Plating System, which is a medical device. This submission focuses on modifications to an existing predicate device and demonstrates substantial equivalence rather than presenting a study to prove acceptance criteria for a novel device or an AI/software component.

Therefore, the information requested in your prompt (e.g., acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth, MRMC study, standalone performance) is not applicable to this document as it pertains to a mechanical medical device seeking clearance based on substantial equivalence to a predicate device, not on clinical performance or AI/software validation.

The "study that proves the device meets the acceptance criteria" in this context is a mechanical testing comparison to the predicate device to demonstrate comparable mechanical properties.

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Comparable mechanical properties to predicate components	Mechanical testing demonstrated comparable mechanical properties to the predicate components.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified (refers to mechanical components, not human data).
Data Provenance: Not applicable for mechanical testing.

3. 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 as this involves mechanical testing, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. 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, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, not an AI/software device.

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

Not applicable. This is a mechanical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for mechanical testing would be established engineering standards or the performance of the predicate device.

8. The sample size for the training set

Not applicable.

9. How the ground truth for the training set was established

Not applicable.

Summary

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MAR 2 1 2005

K 0505/2
Special 510(k)

Summary of Safety and Effectiveness

Stryker Locked Plating System

Proprietary Name:	Stryker Locked Plating System
Common Name:	Bone Plate System
Classification Name and Reference:	Single/Multiple Component Metallic BoneFixation Appliances and Accessories, 21 CFR §888.3030Smooth or Threaded Metallic Bone FixationFastener, 21 CFR §888.3040
Proposed Regulatory Class:	Class 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 25, 2005

Description:

This Special 510(k) submission is intended to address modifications to the predicate Stryker Plating System.

Intended Use:

The subject and predicate devices are internal fixation plates, screws and accessories of the r no basyon attryker Locked Plating System is intended for use in long bone fracture fixation. The byeten. The Bujates are indicated for fixation of long bone fractures including but not limited to fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.

Substantial Equivalence:

The subject components share the same intended use, and basic design concepts as that of the currently available plates in the Stryker Plating System. Mechanical testing demonstrated comparable mechanical properties to the predicate components.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.

MAR 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Susan Krasny, Ph.D., RAC Director of Clinical Research/Regulatory Affairs Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K050512

Trade/Device Name: Stryker Locked Plating System Regulation Numbers: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HRS, HWC Dated: March 26, 2005 Received: March 31, 2005

Dear Dr. Krasny:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encroome) to regard date of the Medical Device Amendments, or to commerce provision to May 20, 1978, the enaordance with the provisions of the Federal Food, Drug, de MCCs that have been require approval of a premarket approval application (PMA). and Cosmetic rear (110. (110.) that the device, subject to the general controls provisions of the Act. The r va may, merelore, mains of the Act include requirements for annual registration, listing of general controls proveturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (sec 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 be sailyeet to back access 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 r least be ad hise a a letermination 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 odelar statuation and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI I rart 0077, atoomig (2 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Susan Krasny, Ph.D., RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your antial equivalence of your device to a legally premits to the are in the break on tor 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 If you uesn't specific advice for Jour 2017 - 0120. Also, please note the regulation entitled, Colliact the Office of Complanes at (210) = 16 = 21 = 21 807.97). You may obtain Misolanding by reference to premation in the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

sincerely yours,

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Stryker Locked Plating System

Indications for Use:

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(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

Page 1 of 1

K 050572

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.