The Stryker Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.

Device Description

The predicate Universal CMF System, which was cleared in K022185, is intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. The Universal CMF System consists of an implant module for the respective anatomical and indicated areas with each containing various screw and plate versions and shapes. The Subject Device of this submission are the Upper-Face AXS screws and Mid-Face AXS (Subject Device) screws. This special 510(k) is submitted due to modifications made to the Subject Device. There have been no modifications to the plates, or meshes of the Predicate Device.

AI/ML Overview

This document describes a 510(k) premarket notification for the Stryker Upper-Face AXS screws and Mid-Face AXS screws, which are part of the Stryker Universal CMF System. This is a Class II medical device (Bone Plate, 21 CFR 872.4760, Product Code JEY).

The submission is a special 510(k), indicating modifications were made to the subject device, but the overall indications for use remain the same as the predicate device (Stryker Universal CMF System – K022185).

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
The Subject Device must meet all pre-defined acceptance criteria set for the Verification & Validation (V&V) testing.	The Subject Device met all pre-defined acceptance criteria, as stated in the "Performance Bench Testing" section.
The Subject Device must perform as intended in the specified use conditions.	The results of the V&V tests data demonstrate that the Subject Device will perform as intended in the specified use conditions.
Technological characteristics of the Subject Device (after modifications) must remain equivalent to the Predicate Device. These include: - Same operating principle - Same mode of fixation (plate fixation with screws) - Same area of contact and contact duration (screws have contact to tissue/bone for >30 days) - Same material	The document states under "B. Technological Characteristics" that "Even with the modification to the Subject Device... the technological characteristics remain the same as the Predicate Device," enumerating these points.

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

The document does not specify the exact sample sizes (number of screws or tests) used for the bench testing. It only generally refers to "Verification and Validation (V&V) testing" being performed.

Data Provenance: The testing was "Performance Bench Testing," implying laboratory-based, in-vitro testing. No country of origin for the data is specified, but the submitter is based in Germany (Stryker Leibinger GmbH& Co. KG) and the contact person is in Portage, Michigan, USA. The testing is retrospective in the sense that it's performed on manufactured devices for regulatory submission, rather than prospective clinical trials.

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

Not applicable. This device is a bone plate and screw system, and the studies performed are bench performance testing, not studies requiring expert interpretation of diagnostic images or clinical outcomes that would necessitate establishing a "ground truth" by medical experts. The acceptance criteria are based on engineering and performance specifications.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is bench performance testing, not a study involving human interpretation or clinical data requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a physical implant device, and its regulatory clearance is based on engineering performance tests and substantial equivalence to a predicate device, not on diagnostic accuracy or reader improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, the "Performance Bench Testing" can be considered a standalone performance evaluation of the device itself (the screws) against predefined engineering criteria, without human interaction during the test execution beyond setting up the experiment. This report focuses on the physical device's performance, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the bench testing would be the engineering specifications, established mechanical properties (e.g., strength, stiffness, fatigue life), and functional performance requirements derived from the intended use and comparison to the predicate device. These are objective, measurable parameters.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth established for one.

Summary

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October 31, 2017

Stryker Jonathan Schell Staff Regulatory Affairs Specialist 750 Trade Centre Wav - Suite 200 Portage, Michigan 49002

Re: K172572

Trade/Device Name: Stryker Upper-Face AXS screws and Mid-Face AXS screws Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: October 4, 2017 Received: October 5, 2017

Dear Jonathan Schell:

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. 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.

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 803); good manufacturing practice requirements as set 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mary S. Runner -S

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental 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 Upper-Face AXS screws and Mid-Face AXS screws

Indications for Use (Describe)

The Stryker Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 5. 510(k) Summary K172572

This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.

I. SUBMITTER

510(k) Owner:	Stryker Leibinger GmbH& Co. KGBoetzinger Strasse 41D-79111 Freiburg, Germany
Submitter/ ContactPerson:	Jonathan SchellStaff Regulatory Affairs SpecialistStryker Craniomaxillofacial750 Trade Centre WayPortage, MI 49002Phone: 269-389-5596Fax: 877-648-7114
Date prepared:	August 25, 2017
II.DEVICE
Trade Name:	Stryker Upper-Face AXS screws and Mid-Face AXS screws
Common or Usualname:	Bone Plating System
Classificationname:	Bone Plate; 21 CFR §872.4760
Regulatory Class:	Class II
Product Code:	JEY

III. PREDICATE DEVICE

Predicate: Stryker Universal CMF System – K022185

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IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The Stryker Universal CMF System is a cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.

The proposed modifications do not alter the Indications for Use statement for the Subject Device. The Subject Device Indications for Use are identical to the Predicate Device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Subject Device is compared to the Predicate Device for substantial equivalence of technological characteristics based on the following criteria:

A. Principle of Operation
B. Technological Characteristics

A. Principle of Operation

The basic operational principle of the Subject Device remains the same as cleared with the Predicate Device: the operating principle for the System is to reconstruct, stabilize and/or provide rigid fixation in the craniomaxillofacial anatomy.

B. Technological Characteristics

Even with the modification to the Subject Device described in this special 510(k), the technological characteristics remain the same as the Predicate Device:

Same operating principle, -
Same mode of fixation: plate fixation with screws, -
Same area of contact and contact duration: the screws have contact to tissue/bone with a duration greater than 30 days, and
-Same material.

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VII. PERFORMANCE DATA

Based on the Risk Analysis performed on the modification to the Subject Device, Verification and Validation testing was performed in support of the substantial equivalence determination.

Biocompatibility and sterility testing are not required as a basis for substantial equivalence. There is no change in the subject device material, manufacturing process, duration or location of contact, or reprocessing methods.

Performance Bench Testing

As stated above, Verification and Validation (V&V) testing was performed on the Subject Device as dictated by the results of the Risk Analysis. A summary of the V&V testing results is included within the submission. The Subject Device met all pre-defined acceptance criteria, and the results of the V&V tests support the substantial equivalence of the Subject Device to the Predicate Device.

Animal Testing

Animal testing was not required as a basis for substantial equivalence.

Clinical Testing

Clinical testing was not required as a basis for substantial equivalence.

VIII. CONCLUSIONS

The results of the V&V tests data demonstrate that the Subject Device will perform as intended in the specified use conditions. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence of the Subject Device to the Predicate Device.

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.