Pangea Platform:
The Pangea Platform is indicated for the internal fixation and stabilization of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including:

Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
Non-unions, malunions, and deformities
Periprosthetic fractures
The Pangea Platform is also indicated for children (2-12 years) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.

Pangea Femur Plating System:
The Pangea Femur Plating System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including:

Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
Non-unions, malunions, and deformities
Periprosthetic fractures

Pangea Tibia Plating System:
The Pangea Tibia Plating System is indicated for the internal fixation and stabilization of tibia bone fractures and osteotomies in normal and osteopenic bone, including:

Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
Non-unions, malunions, and deformities
Periprosthetic fractures

Pangea Humerus Plating System:
The Pangea Humerus Plating System is indicated for the internal fixation and stabilization of humerus bone fractures and osteotomies in normal and osteopenic bone, including:

Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
Non-unions, malunions, and deformities
Periprosthetic fractures

Device Description

This traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the Pangea Platform, Pangea Femur Plating System, Pangea Humerus Plating System, and Pangea Tibia Plating System. This line extension consists of Class II instruments intended to assist in targeting.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Stryker Pangea Platform and related plating systems. This document outlines the regulatory review and clearance of a medical device based on substantial equivalence to a predicate device, rather than a study demonstrating the device meets acceptance criteria through its own performance evaluation.

Specifically, the text states for "Performance Data":

Non-Clinical Performance: "The new subject devices... are reusable and provided non-sterile. Comparative assessment to the predicate and reference systems demonstrated substantial equivalence. Testing was performed on the subject devices to verify that the T20 and T15 targeting construct can withstand typical physical loads during its use using functional aging. A biocompatibility safety evaluation was performed per ISO 10993-1 to support the verification of biological safety."
Clinical Performance: "Clinical data was not needed for the subject devices to demonstrate substantial equivalence to the predicate devices."

The conclusion is that "The subject devices have identical intended use and indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design and labeling and are manufactured and sterilized using same materials and processes as the predicate devices. The performance analyses demonstrate that: Any differences do not raise new questions of safety and effectiveness; and The subject devices are at least as safe and effective as the legally marketed predicate devices."

Therefore, the document does not present a study with acceptance criteria and reported device performance in the way typically expected for a new AI/software device or a device requiring new clinical efficacy data. Instead, it relies on the concept of "substantial equivalence" to a predicate device.

Given this, I cannot extract most of the requested information, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets, as this type of information is not present in the provided 510(k) summary for this particular device submission.

I will, however, attempt to fill in what information can be inferred or directly stated from the text in relation to the non-clinical performance and the basis for clearance.

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

Acceptance Criteria (Inferred from Substantial Equivalence and Non-Clinical Testing)	Reported Device Performance (Inferred from Substantial Equivalence and Non-Clinical Testing)
Material/Design equivalence to predicate devices	Subject devices are identical in intended use, indications for use, operating principle, basic design, labeling, materials, and processes to predicate devices.
Mechanical integrity during typical physical loads	The T20 and T15 targeting construct can withstand typical physical loads during use, as verified by functional aging testing.
Biocompatibility safety	A biocompatibility safety evaluation performed per ISO 10993-1 supports biological safety.
No new questions of safety and effectiveness compared to predicate	Performance analyses demonstrate no new questions of safety and effectiveness caused by any differences.
At least as safe and effective as legally marketed predicate devices	Performance analyses demonstrate the subject devices are at least as safe and effective.

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

Test Set Sample Size: Not specified in the provided text. The non-clinical testing mentioned "functional aging" but did not specify the number of units or cycles.
Data Provenance: Not specified. The testing was non-clinical.

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 no clinical or human-expert-based ground truth was established for this submission. The evaluation was primarily based on engineering and biocompatibility testing, and comparison to predicate devices.

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

Not applicable for this type of submission.

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. The device described is a metallic bone fixation appliance and accessories, not an AI or imaging diagnostic device that would typically undergo an MRMC study.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this 510(k) clearance is primarily based on compliance with established engineering standards (e.g., for mechanical load and biocompatibility) and the demonstrated "substantial equivalence" to legally marketed predicate devices, which are assumed to be safe and effective.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device.

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

Not applicable, as this is not an AI/machine learning device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 6, 2024,

Stryker GmbH Ashley Allison Senior Regulatory Affairs Specialist Bohnackerweg 1 Selzach, 2545 Switzerland

Re: K242445

Trade/Device Name: Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: August 16, 2024 Received: August 16, 2024

Dear Ashley Allison:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CHRISTOPHER FERREIRA -S

Christopher Ferreira, MS Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242445

Device Name

Pangea Platform;

Pangea Femur Plating System;

Pangea Humerus Plating System ;

Pangea Tibia Plating System

Indications for Use (Describe)

Pangea Platform:

The Pangea Platform is indicated for the internal fixation and stabilization of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including:

· Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
· Non-unions, malunions, and deformities
· Periprosthetic fractures

The Pangea Platform is also indicated for children (2-12 vears) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.

Pangea Femur Plating System

The Pangea Femur Plating System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including:

· Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
· Non-unions, malunions, and deformities
· Periprosthetic fractures

Pangea Tibia Plating System

The Pangea Tibia Plating System is indicated for the internal fixation and stabilization of tibia bone fractures and osteotomies in normal and osteopenic bone, including:

· Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
· Non-unions, malunions, and deformities
· Periprosthetic fractures

Pangea Humerus Plating System

The Pangea Humerus Plating System is indicated for the internal fixation and stabilization of humerus bone fractures and osteotomies in normal and osteopenic bone, including:

· Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
· Non-unions, malunions, and deformities
· Periprosthetic fractures

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K242445

Stryker GmbH Pangea Platform, Pangea Femur Plating System, Pangea Humerus Plating System and Pangea Tibia Plating System Traditional 510(k) Premarket Notification

510(k) Summary

Proprietary name:	Pangea Platform, Pangea Femur Plating System, Pangea Humerus PlatingSystem, and Pangea Tibia Plating System.
Common name:	Plate, Fixation, Bone and Screw, Fixation, Bone
Regulation Number:	21 CFR 888.3030: Single/multiple component metallic bone fixationappliances and accessories
	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Product Code(s):	HRS, HWC
Device Class:	Class II
Sponsor:	Stryker GmbHBohnackerweg 12545 Selzach, Switzerland
Contact Person:	Ashley AllisonSenior Specialist, Regulatory Affairs325 Corporate DrMahwah, NJ 07430Phone: 269 845 7922ashley.allison@stryker.com
Date Prepared:	August 16, 2024
Predicate Device:	Pangea Platform (K231257), Pangea Femur Plating System, Pangea HumerusPlating System, Pangea Tibia Plating System (K231262)
Device Description:	This traditional 510(k) submission is being supplied to the U.S. FDA to gainclearance to market the new devices of the Pangea Platform, Pangea FemurPlating System, Pangea Humerus Plating System, and Pangea Tibia PlatingSystem. This line extension consists of Class II instruments intended to assistin targeting.
Indications for Use:	Pangea Platform:The Pangea Platform is indicated for the internal fixation and stabilization ofbone fractures, osteotomies, and arthrodesis in normal and osteopenic bone,including:
	• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures• Non-unions, malunions, and deformities• Periprosthetic fractures
	The Pangea Platform is also indicated for children (2-12 years) andadolescents (12 - 21 years) for the internal fixation and stabilization of bonefractures of the diaphysis and metaphysis in which growth plates have fusedor in which growth plates will not be crossed by implants.

Pangea Femur Plating System:

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K242445

Stryker GmbH Pangea Platform, Pangea Femur Plating System, Pangea Humerus Plating System and Pangea Tibia Plating System Traditional 510(k) Premarket Notification

The Pangea Femur Plating System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including:

Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
· Non-unions, malunions, and deformities
· Periprosthetic fractures

Pangea Tibia Plating System:

The Pangea Tibia Plating System is indicated for the internal fixation and stabilization of tibia bone fractures and osteotomies in normal and osteopenic bone, including:

· Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
· Non-unions, malunions, and deformities
Periprosthetic fractures

Pangea Humerus Plating System:

The Pangea Humerus Plating System is indicated for the internal fixation and stabilization of humerus bone fractures and osteotomies in normal and osteopenic bone, including:

· Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
Non-unions, malunions, and deformities
Periprosthetic fractures

The indications of the subject devices are identical as those of the predicate Comparison to predicate device: devices. There is no change in the fundamental scientific technology shared by both the subject and predicate devices.

Performance Data:

Non-Clinical Performance:

The new subject devices of Pangea Platform, Pangea Femur Plating System, Pangea Humerus Plating System, and Pangea Tibia Plating System are reusable and provided non-sterile. Comparative assessment to the predicate and reference systems demonstrated substantial equivalence. Testing was performed on the subject devices to verify that the T20 and T15 targeting construct can withstand typical physical loads during its use using functional aging. A biocompatibility safety evaluation was performed per ISO 10993-1 to support the verification of biological safety.

Clinical Performance:

Clinical data was not needed for the subject devices to demonstrate substantial equivalence to the predicate devices.

The subject devices have identical intended use and indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design and labeling and are manufactured and sterilized using same materials and processes as the predicate devices. The performance analyses demonstrate that:

Any differences do not raise new questions of safety and effectiveness; and
The subject devices are at least as safe and effective as the legally marketed predicate devices.

Conclusion:

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.