The PEEK Customized Cranial Implant Kit is indicated for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 3.5 years of age and older.

Device Description

The Stryker PEEK Customized Cranial Implant (CCI) product offerings provide customized cranial or craniofacial patient specific implants based on CT data and surgeon input.

AI/ML Overview

The Stryker PEEK Customized Cranial Implant is a medical device intended for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton for patients 3.5 years of age and older.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define quantitative acceptance criteria for this device in the same way one might for a diagnostic AI. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device and the discussion of benefits outweighing risks.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Safe for implantation, no adverse biological reactions.	Not explicitly re-tested for this specific submission. Stated: "Biocompatibility and sterility testing of the device is not required as a basis for substantial equivalence. There is no change in the material, duration of contact, or reprocessing methods for the PEEK CCI." Implies performance is equivalent to predicate, which has established biocompatibility.
Performance Bench Testing: Mechanical integrity and fit.	Not explicitly re-tested for this specific submission. Stated: "As the Performance Bench testing of the Predicate Device are valid for the Subject Device, and because the performance bench testing of the both devices are identical, an additional performance bench testing was not required for the Subject Device as a basis for substantial equivalence." Implies performance is equivalent to predicate.
Clinical Safety & Effectiveness: Safe and effective for its indicated use (augmentation/restoration of cranial/craniofacial deformities in patients ≥ 3.5 years old).	"Clinical studies and findings show the potential benefits associated with the use of the device outweigh the potential risks associated with the Subject Device... the safe and effective application of alloplastic cranioplasties in patient 3.5 years of age and above." (References provided: Nguyen et al. 2018, Rocque et al. 2018, Ma et al. 2018, Sainsbury et al. 2017, Fu et al. 2016). These studies support the use of PEEK and other alloplastic implants in a similar patient population and application.
Risk Mitigation: Potential risks adequately addressed.	Identified potential risks (Growth related risks, Radiation related risks). Mitigation: IFU contains information regarding growth disturbance, and scan protocols include information to minimize ionizing radiation dose using low-dose and child-size CT-protocols. The overall benefit and risk ratio remains equivalent to the predicate.

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

This document does not describe a "test set" in the context of an algorithm or diagnostic device. The evaluation relies on a review of existing scientific peer-reviewed publications. The sample sizes are derived from these referenced clinical studies:

Nguyen et al. 2018: 136 cases utilizing custom CAD/CAM implants for complex craniofacial reconstruction in children. (Data provenance not specified, but likely multi-center based on similar studies).
Rocque et al. 2018: Multicenter study at 13 institutions. (Specific sample size for PEEK implants not given, but context suggests a larger cohort of cranioplasty patients).
Ma et al. 2018: 84 cases of cranioplasty (6 PEEK implants, 36 split calvarial grafts, 33 titanium meshes).
Sainsbury et al. 2017: Cases involving bilateral malar reconstruction with customized PEEK implants. (Specific sample size not given, but likely a smaller case series).
Fu et al. 2016: Pediatric patients, 73% received alloplastic implants (PEEK, PMMA, MEDPOR, titanium), 28% autologous reconstructions. (Specific sample size not given, but implied to be substantial given the percentages).

The data provenance is from published clinical literature, which often encompasses retrospective and/or prospective studies conducted in various clinical settings. Specific country of origin is not detailed for each individual study in this summary.

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

Not applicable. This is not a study evaluating a diagnostic algorithm where "ground truth" is established by experts on a test set. The clinical evidence is derived from existing peer-reviewed literature, where the outcomes of the surgical procedures serve as the "truth" regarding the device's performance in patients.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" or adjudication process described as part of this 510(k) submission.

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

Not applicable. This device is a customized cranial implant, not an AI-assisted diagnostic tool. Therefore, studies on human readers improving with or without AI assistance are not relevant.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the effectiveness and safety of the PEEK customized cranial implant is derived from:

Clinical Outcomes Data: Published results detailing patient outcomes following the implantation of PEEK and other alloplastic cranioplasties (e.g., successful augmentation, restoration of bony defects, complication rates, follow-up over time).
Clinical Experience/Expert Consensus (within referenced studies): The studies reflect the collective experience and findings of clinicians and surgeons regarding the use and performance of these types of implants.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set. The design of the custom implant for a specific patient is based on that individual patient's CT data, not a general training set.

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

Not applicable, as there is no training set for this device in the context of an algorithm.

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 the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 11, 2019

Stryker Zainab Amini Regulatory Affairs Specialist 750 Trade Centre Way - Suite 200 Portage, Michigan 49002

Re: K190229

Trade/Device Name: Stryker PEEK Customized Cranial Implant Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO Dated: June 7, 2019 Received: June 10, 2019

Dear Zainab Amini:

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

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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 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 (OS) 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,

Matthew Krueger 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K190229

Device Name

Stryker PEEK Customized Cranial Implant Kit

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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K190229 stryker

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 I.

510(k) Owner:	Stryker Leibinger GmbH& Co. KGBoetzinger Strasse 41D-79111 Freiburg, Germany
Submitter/ ContactPerson:	Zainab AminiRegulatory Affairs SpecialistStryker Craniomaxillofacial750 Trade Centre WayPortage, MI 49002Phone: 269-389-8349Fax: 877-648-7114
Date prepared:	July 10, 2019
II.DEVICE
Trade Name:	Stryker PEEK Customized Cranial Implant
Common or Usualname:	Customized Cranial Implant
Classificationname:	Preformed alterable cranioplasty plate 21 CFR §882.5320
Regulatory Class:	Class II
Product Code:	GWO

PREDICATE DEVICE III.

Predicate: K153248, Stryker PEEK Customized Cranial Implant Kit

This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

The Stryker PEEK Customized Cranial Implant (CCI) product offerings provide customized cranial or craniofacial patient specific implants based on CT data and surgeon input.

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V. INDICATIONS FOR USE

The PEEK Customized Cranial Implant Kit is indicated for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 3.5 years of age and older.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The PEEK CCI for Children design is compared to its Predicate Device for substantial equivalence based on the following criteria:

A. Principle of Operation
B. Technological Characteristics

A. Principle of Operation

The basic operational principle of the PEEK CCI for Children is that the PEEK Customized Cranial Implant is intended to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial and craniofacial skeleton.

B. Technological and Operational Characteristics

Both the Subject and Predicate Devices have similar technological characteristics, and the operating principle, mode of fixation, and design and manufacturing processes are all identical.

VII. PERFORMANCE DATA

Biocompatibility Testing

Biocompatibility and sterility testing of the device is not required as a basis for substantial equivalence. There is no change in the material, duration of contact, or reprocessing methods for the PEEK CCI. As the design and manufacturing processes, materials, and packaging processes are identical for both the Predicate and the Subject Devices.

Performance Bench Testing

Both the Subject and Predicate Devices are designed and manufactured identically. As the Performance Bench testing of the Predicate Device are valid for the Subject Device, and because the performance bench testing of the both devices are identical, an additional performance bench testing was not required for the Subject Device as a basis for substantial equivalence.

Animal Testing

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

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Clinical Testing

Clinical studies and findings show the potential benefits associated with the use of the device outweigh the potential risks associated with the Subject Device. Clinical studies provided within this submission indicates that the potential benefits for the patient will be greater from the use of the Subject Device when compared to the potential risks. The following table provides the scientific peer-reviewed publications describing the safe and effective application of alloplastic cranioplasties in patient 3.5 years of age and above.

Source	Summary
Nguyen et al.2018	Report on clinical outcomes following cranioplasty inchildren with patient-specific PEEK, titanium, and PMMAimplants. Follow-up of an average of 30 months. Patient-specific implants provide significant degrees of freedom tothe surgeon which bone grafting would not be able toaccommodate because of lack of donor availability or sheercomplexity of contouring. The authors did not find anyindications that the implants pose a problem with thegrowing skeleton and suggested safety at ages greater than3 years.
Rocque et al.2018	Multicenter study at 13 institutions. Cranioplasty boneresorption is predicted by patient age. Reconstruction withPEEK implants is described in the study.
Ma et al.2018	Cranioplasty with autologous bone in 84 cases, 36 splitcalvarial graft reconstructions, six PEEK implants, 33titanium meshes. Average follow-up: 4 years. Goodsymmetry and effective brain protection were achieved.
Sainsbury etal. 2017	Bilateral malar reconstruction with customized PEEKimplants based on CT data. The authors highlight theimproved implant-bone surface interface withthecustomized medical devices.
Fu et al. 2016	Comparison of clinical outcomes achieved with autologousand alloplastic cranioplasty in pediatric patients. 73% of theincluded patients received alloplastic implants (PEEK,PMMA, MEDPOR, titanium) while the remaining 28%were treated with autologous reconstructions. Patients werefollowed-up for up to 9 years. The authors conclude thatalloplastic cranioplasty in the pediatric population is a safealternative, when autologous cranial bone is not available.

TABLE 1 RELEVANT CLINICAL DATA

Potential Benefits

Potential benefits associated with the Subject Device outweigh the potential risks. Overall, the Subject Device implant offers similar benefits as the Predicate Device because the physical principle of replacing missing bone is identical. However, through investigation it was identified that the Subject Device's targeted age group would have many potential benefits that are of greater importance/magnitude for young patients.

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Potential Risks

The potential risks associated with the device are increasing radiation exposure and growth issues. These risks have been assessed and mitigation is provided within this submission which reduces these potential risks for the patient.

	Potential Hazard	Potential Harm	Risk Mitigation in Labelling
Growth related risks	Brain compressionagainst implant	PainRemoval of implantBrain/soft tissue injuryreversibleBrain/soft tissue injuryirreversible	IFU contains informationregarding growth disturbance
	Implant interferencewith growing bone	Poor aestheticsresulting in implantremovalAnnoyance	IFU contains informationregarding growth disturbance
	Loosening ofimplant	Neurological symptomsrequiring surgeryTemporary neurologicalsymptoms	IFU contains informationregarding growth disturbance
	Radiation related risks	New / additionalscan for implantdesign required	Radiation inducedneoplasia

TABLE 2 POTENTIAL RISKS IDENTIFIED FOR THE SUBJECT DEVICE:

To mitigate the risks, the Instructions for Use (IFU) includes information associated with growth related risks. The IFU and the scan protocol include information to minimize ionizing radiation dose by using low-dose and child-size CT- protocols when appropriate.

CONCLUSIONS

The clinical studies provided within this submission, show the safe and effective use of the patient specific alloplastic implants for the intended patient population. Table 1 provides references and summary of these clinical studies.

A Benefit and Risk Factor analysis was conducted for the Subject Device. Both the potential benefits and risks of the Subject Device are increased when compared to the Predicate Device. However, the overall benefit and risk ratio remains equivalent. The product labeling contains corresponding information regarding the potential risks of growth disturbance and radiation exposure for the intended patient population. Table 2 provides an overview of the risk mitigation measures.

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The safety and effectiveness of both the Subject and Predicate Devices are equivalent. Both devices are designed and manufactured identically, and they both have equivalent Intended Use and Technological Characteristics.

In conclusion, the potential benefits associated with the use of the Subject Device outweigh its potential risks for the patient. 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.

References

Fu, K. J., Barr, R. M., Kerr, M. L., Shah, M. N., Fletcher, S. A., Sandberg, D. I., ... Greives, M. R. (2016). An outcomes comparison between autologous and alloplastic cranioplasty in the pediatric population. Journal of Craniofacial Surgerv, 27(3), 593-597. https://doi.org/10.1097/SCS.0000000000000000002491
Ma, I. T., Symon, M. R., Bristol, R. E., Beals, S. P., Joganic, E. F., Adelson, P. D., ... Singh, D. J. (2018). Outcomes of Titanium Mesh Cranioplasty in Pediatric Patients. The Journal of Craniofacial Surgery, 29(1), 99-104. https://doi.org/10.1097/SCS.0000000000000004045
Nguyen, P. D., Khechoyan, D. Y., Phillips, J. H., & Forrest, C. R. (2018). Custom CAD/CAM implants for complex craniofacial reconstruction in children: Our experience based on 136 cases. Journal of Plastic, Reconstructive and Aesthetic Surgery, 18(30251-1), 1-9. https://doi.org/10.1016/j.bjps.2018.07.016
Rocque, B. G., Agee, B. S., Thompson, E. M., Piedra, M., Baird, L. C., Selden, N. R., ... Lam, S. K. (2018). Complications following pediatric cranioplasty after decompressive craniectomy: a multicenter retrospective study. Journal of Neurosurgery: Pediatrics, 22(3), 225-232. https://doi.org/10.3171/2018.3.PEDS17234.
Sainsbury, D. C. G., George, A., Forrest, C. R., & Phillips, J. H. (2017). Bilateral Malar Reconstruction Using Patient-Specific Polyether Ether Ketone Implants in Treacher-Collins Syndrome Patients With Absent Zygomas. The Journal of Cramiofacial Surgery, 28(2), 515-517. https://doi.org/10.1097/SCS.0000000000003351

Regulation Number and Section

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).