The Delta Resorbable Fixation System is intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients.

The self-tapping screws and low profile emergency screws are intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction, and can be used in pediatric patients older than 29 days and up to two (2) years of age (infants).

Device Description

The Stryker Resorbable Fixation System (also referred to as Delta System or Stryker Delta Resorbable Fixation System; marketed as DualStart) is a cranio-maxillofacial plating system intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The reference device can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures. It consists of resorbable bone fixation plates, meshes, and screws made of a copolymer of poly lactide and poly glycolide.

Through this submission there is no change to the existing articles within the Delta System. The scope of this submission covers the addition of screws to the Delta System, which are shown as a modification of screws of the reference device to create the addition of self-tapping screws (STS) and low profile emergency screws (LPES). The subject STS and LPES, only, have a limited patient population of pediatric patients older than 29 days and up to two (2) years of age (infants).

AI/ML Overview

The provided text describes the acceptance criteria and supporting studies for the Stryker Resorbable Fixation System (K231208).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Test)	Reported Device Performance (Result)	Standard
Verification test (Initial)	Insertion test	Passed	ASTM F2502
Verification test (After real-time degradation)	Pull-out test	Passed	ASTM F2502
Verification test (After real-time degradation)	Inherent viscosity	Passed	ASTM F2502
Usability validation	Task performance (evaluated for use error)	Passed	N/A
Usability validation	Knowledge tasks	Passed	N/A
Usability validation	Rating questions after task performance	Passed	N/A
Bioburden	Bioburden tests (no new worst-case introduced with modified screw geometries)	Passing result	N/A

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

The document does not explicitly state the numerical sample size for the test set for the performance bench testing (e.g., number of screws tested for insertion or pull-out). It generically states "Verification and validation testing protocols were constructed to ensure testing captured this specific limited patient population."

Data Provenance: The studies were conducted by Stryker Leibinger GmbH & Co. KG and are presumed to be internal company studies. The country of origin for the data is not specified, but the company address is in Freiburg, Germany. The studies are prospective in nature, as they are part of a premarket notification for a modified device.

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

For the usability validation, the document mentions "user validation testing" and "human factors and usability engineering," which would typically involve end-users (e.g., surgeons, medical staff). However, the number of experts used and their specific qualifications are not provided in this document.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test sets (e.g., 2+1, 3+1, none). The "Passed" results imply direct measurement against established criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The device in question is a physical fixation system (screws), not a diagnostic imaging AI, so an MRMC study comparing human readers with and without AI assistance is not applicable. The studies focus on the physical and functional performance of the device and its usability.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This device is a physical medical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.

7. Type of Ground Truth Used

For the performance bench testing:

The ground truth is established by objective engineering measurements against the performance requirements defined by the ASTM F2502 standard and internal specifications (e.g., successful insertion, specified pull-out strength, acceptable inherent viscosity).

For the usability validation:

The ground truth is established by user validation through direct observation of task performance (evaluating for use error), assessment of knowledge (knowledge tasks), and subjective feedback (rating questions). This implies that the 'ground truth' for usability is defined by the absence of use errors, successful completion of knowledge tasks, and positive user ratings.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device; there is no "training set" in the context of machine learning or AI models. The design and manufacturing processes are validated through traditional engineering methods and testing.

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

Not applicable. As there is no training set for an AI/algorithm, there is no ground truth established for a training set.

Summary

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August 14, 2023

Image /page/0/Picture/1 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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Stryker Leibinger GmbH & Co. KG Gregory Gohl Senior Regulatory Affairs Specislist Boetzinger Strasse 41 D-79111 Freiburg, Germany

Re: K231208

Trade/Device Name: Stryker Resorbable Fixation System Regulation Number: 21 CFR 882.5360 Regulation Name: Cranioplasty Plate Fastener Regulatory Class: Class II Product Code: HBW Dated: May 19, 2023 Received: July 14, 2023

Dear Gregory Gohl:

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. 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 located 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.

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) for

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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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-regulatoryassistance/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.

Image /page/1/Picture/5 description: The image shows a digital signature of Adam D. Pierce -S. The signature indicates that the document was digitally signed by Adam D. Pierce -S on August 14, 2023. The timestamp of the signature is 10:22:50 with a time zone offset of -04'00'.

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231208

Device Name Stryker Resorbable Fixation System

Indications for Use (Describe)

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)

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Section 5. 510(k) Summary

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

SUBMITTER [§807.92(a)(1)] I.

510(k) Owner:	Stryker Leibinger GmbH& Co. KGBoetzinger Strasse 41D-79111 Freiburg, Germany
Submitter / ContactPerson:	Gregory GohlSr. Regulatory Affairs SpecialistStryker Craniomaxillofacial (CMF)1941 Stryker WayPortage, MI 49002
	Phone: 269-370-1476
Date prepared:	August 14, 2023

DEVICE [§807.92(a)(2)] II.

Trade Name:	Stryker Resorbable Fixation System
Abbreviated Name:	Delta System / Delta Resorbable Fixation System
Common or Usual Name:	Resorbable Bone Plating System
Device:	Stryker Resorbable Fixation System
Classification Name &Regulation Description:	Fastener, Plate, Cranioplasty; per 21 CFR §882.5360
Regulation MedicalSpecialty & Review Panel:	Neurology (OHT5/DHT5A – Office of Neurological,Neurointerventional, and Neurodiagnostic Devices)
Primary Product Code:	HBW
Regulatory Device Class:	Class II

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III. PREDICATE DEVICE [§807.92(a)(3)]

A. Predicate Device: Stryker Universal Neuro III System AXS Screw - K171152

B. Reference Device: Stryker Resorbable Fixation System - K213777

IV. DEVICE DESCRIPTION [§807.92(a)(4)]

A. Submission Branch of Subject Device: Neurology (OHT5/DHT5A Office of Neurological, Neurointerventional, and Neurodiagnostic Devices)
B. Subject Device: Stryker Resorbable Fixation System (also referred to as Delta System or Stryker Delta Resorbable Fixation System; marketed as DualStart)

The predicate Stryker Universal Neuro III System is intended for reconstruction, stabilization, and/or rigid fixation of non-load-bearing bony areas subsequent to craniotomy, craniectomy, and cranial features in adults and adolescents (age 12 and higher). The reference device Stryker Resorbable Fixation System is a cranio-maxillofacial plating system intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The reference device can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures. It consists of resorbable bone fixation plates, meshes, and screws made of a copolymer of poly lactide and poly glycolide.

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INDICATIONS FOR USE [§807.92(a)(5)] V.

Feature	Predicate Device	Subject Devices (only)	Explanation of Differences
Indications for Use	The Stryker Universal Neuro III System is intended for reconstruction, stabilization, and/or rigid fixation of non-load-bearing bony areas subsequent to craniotomy, craniectomy, and cranial fractures in adults and adolescents (age 12 and higher).	NeuroThe Delta Resorbable Fixation System is intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients.	Similar

TABLE 5-1: COMPARISON OF INDICATIONS FOR USE (PREDICATE)

TABLE 5-2: COMPARISON OF INDICATIONS FOR USE AND RELATED REFERENCE DEVICE)

Feature	Reference Device	Subject Devices (only)	Explanation ofDifferences
Indications for Use(overall Delta System)	NeuroThe Delta Resorbable FixationSystem is intended for use in thefixation of bones of the cranialskeleton affected by trauma orfor reconstruction. The systemcan be used in both adult andpediatric patients.	NeuroThe Delta Resorbable FixationSystem is intended for use in thefixation of bones of the cranialskeleton affected by trauma or forreconstruction. The system can beused in both adult and pediatricpatients.	Identical
Indications for Use(subject devices only)	Neuro	NeuroThe self-tapping screws and lowprofile emergency screws areintended for use in the fixation ofbones of the cranial skeletonaffected by trauma or forreconstruction, and can be used inpediatric patients older than 29days and up to two (2) years ofage (infants).	For subject deviceSTS and LPESscrews, only,restriction ofpatient populationto pediatricpatients older than29 days and up totwo (2) years ofage (infants).
Area of Application	Craniofacial and midface	Craniofacial and midface	Identical
Patient Contact,Duration ofImplantation withinBody	Tissue/Bone, Permanent	Tissue/Bone, Permanent	Identical

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [§807.92(a)(6)]

The subject device is compared to its predicate and reference device system for substantial equivalence of technological characteristics based on the criteria of pilot hole preparation process flow, geometrical modifications, and patient population.

The technological characteristics of the subject device that remain the same as the reference device include material of construction, manufacturing process, sterilization process, packaging materials, and anatomical area indication.

A. Pilot Hole Preparation Process Flow

The operational principle of the Stryker Resorbable Fixation System is a cranio-maxillofacial plating system intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The method of pilot hole preparation has been modified for the self-tapping screw (STS) subject device. The reference device system requires pre-drilling and pre-tapping of the pilot hole prior to insertion. The STS subject screws require only pre-drilling of the pilot hole prior to screw insertion, thus removing the pre-tapping step. No modifications of principles of operation are made to the low profile emergency screw (LPES) subject device.

B. Geometry Modifications

The subject devices incorporate a modification to the geometry to support the mechanical functionality of a self-tapping screw. Modifications to the subject devices include the thread geometry and screw head dimensions. The interfaces for the subject screws have been reviewed, confirming there is no impact to the intended product interfaces of the subject screws as compared to the reference device screws.

C. Patient Population

The subject devices have a limited patient population of pediatric patients older than 29 days and up to two (2) years of age (infants), compared to the reference device Delta System, which has a patient population of adults and pediatric patients.

VII. PERFORMANCE DATA [§807.92(b)(7)]

The modifications for the subject devices in this submission include a limited patient population of pediatric patients older than 29 days and up to two (2) years of age (infants), removal of the tapping step from pilot hole preparation (self-tapping screw [STS] only), and screw geometry. The limited patient population was determined based on a business decision, focusing new product introduction on our primary customer and patient base, of pediatric patients older than 29 days and up to two (2) years of age (infants). Verification and validation testing protocols were constructed to ensure testing captured this specific limited patient population, in accordance with the FDA 2014 guidance Premarket Assessment of Pediatric Medical Devices.

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The material of construction, manufacturing process, sterilization process, and packaging materials remain unchanged compared to the reference device, therefore biocompatibility testing, shelf life testing, and sterilization testing are out of scope of this submission, and adopted from the reference device system. Bioburden tests were performed to further affirm no new worst-case is introduced with the modified screw geometries, which concluded a passing result.

Verification test criteria and methods were identified to evaluate the performance of the subject screws according to the proposed limited patient population of pediatric patients older than 29 days and up to two (2) years of age (infants). Modification of the operating principle, pilot hole preparation, for the STS was additionally evaluated through performance testing. The impact of screw geometry modification on material properties during real-time degradation was evaluated. The following performance tests were performed to support the substantial equivalence determination of the subject screws to the predicate and reference device system based on the modifications described:

Characteristic	Test	Result	Standards
Verification test	Insertion test	Passed	ASTM F2502
Verification test afterreal-time degradation	Pull-out test	Passed	ASTM F2502
Verification test afterreal-time degradation	Inherent viscosity	Passed	ASTM F2502

	TABLE 5-2: PERFORMANCE BENCH TESTING

A risk analysis was performed, and user validation testing, which also included human factors and usability engineering, in accordance with the FDA 2016 guidance Applying Human Factors and Usability Engineering to Medical Devices, was performed in support of the substantial equivalence determination. The validation study was constructed to confirm use error is under control, a comprehension of the Instructions for Use (IFU) is understood, and user needs are met. With respect to the modifications made to the subject devices, the validation evaluated the usability of the workflow steps, functionality of the devices, compatibility of related products or processes, and knowledge comprehension of labeling and IFU. Specifically, the knowledge comprehension addressed the ability to comprehend the modification to the pilot hole preparation and the limitation to the patient population. The validation testing concluded a passing result based on the data collected and reviewed in the study.

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K231208 Page 6 of 6

Characteristic	Test	Result
Usability validation	Task performance (evaluated for use error)	Passed
Usability validation	Knowledge tasks	Passed
Usability validation	Rating questions after task performance	Passed

TABLE 5-3: USABILITY VALIDATION TESTING

Performance Bench Testing

Performance bench testing was performed in the form of verification testing to confirm substantial equivalence. See Table 5-2.

Animal Testing

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

Clinical Testing [§807.92(b)(2)]

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

VIII. CONCLUSION [§807.92(b)(3)]

In summary, the Stryker Resorbable Fixation System is substantially equivalent to the predicate and to the reference device system. The modifications proposed for the subject devices include the removal of a pilot hole preparation step (STS only), screw geometry modification, and restriction of the patient population. The material of construction, sterilization process, manufacturing process, packaging components, and anatomical area intended use / indication remain unchanged and identical to the reference device system. The scope of modifications concludes no impact to biocompatibility, sterilization, and shelf life. The performance verification testing supports that the performance of the subject screws is substantially equivalent to the reference device. The user validation study, which also considered human factors and usability engineering, confirmed use error is under control, a comprehension of the IFU is understood, and user needs are met, all of which supports the determination of substantial equivalence to the predicate and reference device system. Overall, the modifications do not raise new questions of safety or effectiveness. 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 to the predicate and reference device system.

Regulation Number and Section

§ 882.5360 Cranioplasty plate fastener.

(a)
Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.(b)
Classification. Class II (performance standards).