The implant is composed of Invibio Polyether Ether Ketone (PEEK-OPTIMA®) and fabricated using the patient's computed tomography (CT) imaging data. The device is provided non-sterile for steam sterilization prior to implantation and is attached to the native bone with commercially available FDA approved cranioplasty fixation systems. The Kelyniam Customized Craniofacial Implant (CCI) is a single use, non-load bearing device which is not intended to support any endosseous dental implants nor be used in areas where their intended use may be compromised in a subsequent surgery in the ora!-maxillofacial area.

The implants will range in size from 50mm X 50mm X 150mm, and the thickness of the implant ranging from 2mm - 4mm with the nominal thickness of 3mm. The sizes and shapes of this implant may vary depending on the patients specific defect area. The implant will attach to native bone using commercially-available cranioplasty fasteners.

The Customized Craniofacial Implant (CCI) is used to correct bony voids of the craniofacial region to include the zygoma, orbital rim, and adjacent bone. The Customized Craniofacial Implant (CCI) will not be used on any of the Maxilla bones that will affect the placement of current or future oralmaxillofacial implants, including endosseous dental implants. Also, the CCI Implant is not for use in the skeletal structures in the maxillofacial and/or oral regions.

AI/ML Overview

The Kelyniam Customized Craniofacial Implant (CCI) is a Class II medical device used to correct bony voids in the craniofacial skeleton. The 510(k) summary and associated documents for K121755 indicate that substantial equivalence to predicate devices was established rather than a study with specific acceptance criteria and performance metrics. Therefore, detailed acceptance criteria in the format of a clinical study are not directly applicable here.

Here's an analysis based on the provided text, focusing on how substantial equivalence was demonstrated:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence determination for a medical device (specifically a cranioplasty plate), the "acceptance criteria" are not reported as numerical performance targets from a clinical study, but rather as design and material characteristics compared to legally marketed predicate devices. The "reported device performance" is the demonstration that the subject device shares these characteristics and works in a similar manner.

Acceptance Criteria (Demonstrated Similarity to Predicates)	Reported Device Performance (Kelyniam CCI)
Intended Use: Correct bony voids in the craniofacial skeleton	Intended to correct bony voids in the Craniofacial skeleton.
Material: PEEK-OPTIMA LT1	Composed of Invibio Polyether Ether Ketone (PEEK-OPTIMA®), specifically PEEK-OPTIMA LT-1.
Form/Customization: Patient-specific, fabricated from CT data	Fabricated using the patient's computed tomography (CT) imaging data, customized to each individual patient's specific CT data.
Sterilization State: Non-sterile	Provided non-sterile for steam sterilization prior to implantation.
Sterilization Method: Steam	Recommended sterilization method is steam sterilization.
Method of Fixation: Attached to native bone with commercially available fixation systems	Attaches to native bone using commercially-available cranioplasty fasteners.
Device Type: Single use, non-load bearing	Single use, non-load bearing device.
Contraindications: Not for endosseous dental implants, not in maxillofacial/oral regions where use may be compromised	Will not be used on maxillia bones affecting dental implants. Not for use in skeletal structures in the maxillofacial and/or oral regions.
Size Range: Length/Width 50mm² - 150mm², Thickness 2mm - 4mm	Length/Width: (50mm² - 150mm²), Thickness: 2mm - 4mm, nominal thickness 3mm.

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

No specific "test set" in the context of clinical trial data is mentioned. The demonstration of substantial equivalence relies on a comparison of the device's design, materials, and intended use with existing legally marketed predicate devices.

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

Not applicable in this context. Substantial equivalence is determined by regulatory review based on documented device characteristics and comparisons to predicates, not by expert consensus on a test set.

4. Adjudication Method for the Test Set:

Not applicable. There was no test set or clinical study requiring adjudication.

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

No MRMC study was performed or mentioned. This device is a physical implant, not a diagnostic or AI-assisted system where MRMC studies are typically relevant. The submission focuses on the safety and effectiveness being substantially equivalent to existing implants.

6. Standalone Performance Study:

No standalone (algorithm-only) performance study was conducted. Again, this device is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" in this context is the safety and effectiveness record of the predicate devices. The Kelyniam CCI draws its claim of safety and effectiveness from demonstrating that it is substantially equivalent to these devices in terms of materials, design, manufacturing, sterilization, and intended use. The FDA's determination of "substantial equivalence" means the device is as safe and effective as the predicates.

8. Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" for this type of device submission, as it's not an AI/ML or diagnostic imaging device.

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

Not applicable.

Summary of the Study (Substantial Equivalence Argument):

The "study" presented here is a Substantial Equivalence Comparison as required for a 510(k) premarket notification. The Kelyniam Customized Craniofacial Implant (CCI) was compared against four predicate devices:

Kelyniam Customized Skull Implant (CSI) (K103582)
Synthes Patient Specific Craniofacial Implant (PSCI) (K053199)
KLS Martin L.P. Patient Contoured Mesh - PEEK (PCM-P) (K072707)
MedCAD AccuShape PEEK Patient Specific Cranial Implant (PSCI) (K110684)

The submission highlights the following points to argue for substantial equivalence:

Material: All devices (subject and predicates) are made from PEEK, specifically PEEK-OPTIMA LT-1.
Customization: All are patient-specific and customized from CT data.
Sterilization: All are sold non-sterile and recommended for steam sterilization.
Similarities in Basic Design and Function: The subject device shares fundamental characteristics with the predicates regarding its purpose (correcting bony voids), material, and manufacturing process.
Differences and Justification:
- The Kelyniam CCI has a slightly broader indicated use within the craniofacial region (including zygoma, orbital rim, and adjacent bone) compared to some predicates (like Kelyniam CSI and MedCAD Accuhape™ PEEK PSCI) which were limited to the cranial skeleton.
- Crucially, the Kelyniam CCI explicitly states it will not be used on maxilla bones that would affect oral-maxillofacial implants, distinguishing it from potential broader applications of the predicates where this might be a concern.

The conclusion of the submission is that these similarities, and the careful delineation of differences (which do not raise new questions of safety or effectiveness), support the conclusion that the Kelyniam Customized Craniofacial Implant (CCI) is as safe and effective as the predicate devices. The FDA concurred with this assessment in its 510(k) clearance letter.

Summary

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K121755

SEP 2 5 2012

age 1 of 3

510(k) Summary

Kelyniam Customized Craniofacial Implant (CCI) .

510(k) Submitter/Owner	Kelyniam Global, Inc.97 River RoadCanton, Connecticut 06019Office (800) 280-8192
------------------------	----------------------------------------------------------------------------------------------

Contact Person: Nicholas Breault Vice President of Production Office (800) 280-8192 Ext. 702 Cell (818) 269-9979 Fax (501) 641-2000
Date of Summary: May 5, 2012

Device Name: Proprietary Name: Kelyniam Customized Craniofacial Implant (CCI) Common Name: Patient Specific Plate Classification Name: "plate, cranioplasty, preformed, non-alterable, ' a class II device in accordance with 21 CRF §882.5330

Panel: Neurology

Product Code: GXN

Indications for Use:

The Kelyniam Customized Craniofacial Implant (CCI) is intended to correct bony voids in the Craniofacial skeleton.

Device Description:

Kelyniam Customized Craniofacial Implant (CCI) K121755 - PEEK-OPTIMA-LT® (IFU)

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	ProposedDevice	Predicate 1	Predicate 2	Predicate3	Predicate 4
Device Name	KelyniamCustomizedCraniofacialImplant(CCI)	KelyniamCustomizedSkull Implant(CSI)	Synthes PatientSpecificCranial/Craniofacial Implant .(PSCI)	KLSMartinPatientContouredMesh-PEEK(PCM-P)	MedCADAccuhape™PEEK PatientSpecificCranialImplant (PSCI)
510(k)number		K103582	K053199	K072707	K110684
Intended use	Correctbony voidsin theCraniofacialskeleton	Correction ofdefects incranial bone	Replace bonyvoids in thecranial/craniofacial skeleton	Replacebony voidsin thecranialand/orcraniofacial skeleton	Correct defects/ replace bonyvoids inthe cranialskeleton.
Material	PEEK-OPTIMALT1	PEEK-OPTIMA LT1	PEEK Optima-LT1	PEEK	PEEK
Size(Length / Width)	(50mm² -150mm²)	(Max -152mm²)	(100mm² -350mm²)	N/A	(10mm² -200mm²)
Thickness	2mm - 4mm	4mm	3mm	N/A	2mm – 4mm
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Non-Sterile
SterilizationMethod	Steam	Steam	Steam	Steam	Steam

Substantial Equivalence Chart

Substantial Equivalence Summary:

The Kelyniam Customized Craniofacial Implant (CCI) is substantially similar to predicate devices currently on the market. These devices include the Kelyniam Customized Skull Implant (CSI) (K103582), the Synthes Patient Specific Craniofacial Implant (PSCI) (K053199), the KLS Martin L.P. Patient Contoured Mesh - PEEK (PCM-P) (K072707) and the MedCAD AccuShape PEEK Patient Specific Cranial Implant (PSCI) (K110684). For a complete list please reference the table above.

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KELYNIAM
K121755

Similar to these other devices the Kelyniam Customized Craniofacial Implant (CCI) implant is manufactured from INVIBIO™ PEEK-OPTIMA LT-1, sold non-sterile and customized to each individual patient's specific CT data. The recommended sterilization method for this device and the predicate devices is steam sterilization.

The Customized Craniofacial Implant (CCI) is used to correct bony voids of the craniofacial region to include the zygoma, orbital rim, and adjacent bone this differs from the Kelyniam Customized Skull Implant (CSI) and the MedCAD Accuhape™ PEEK Patient Specific Cranial Implant (PSCI) that are only used to correct bony voids in the Cranial skeleton.

Therefore, this supports the conclusion that the subject device is as safe and effective as the predicate devices.

Kelyniam Customized Craniofacial Implant (CCI) K121755 - PEEK-OPTIMA-LT® (IFU)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned above a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP
2 5 2012

Kelyniam Global, Inc. c/o Nicholas Breault Vice President of Production 97 River Road, Suite A Canton, Connecticut 06019

Re: K121755

Trade/Device Name: Kelyniam Customized Craniofacial Implant (CCI) Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed non-alterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: August 31, 2012 Received: August 31, 2012

Dear Mr. Breault:

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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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L. KELYNIAM

K121755
Page 1 of 1

Indications for Use

510(K) Number (If Known): K121755

Device Name: Kelyniam Customized Craniofacial Implant (CCI)

Indications For Use: The Kelyniam Customized Craniofacial Implant (CCI) is intended to correct bony voids in the Craniofacial skeleton

Prescription Use: YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use: NO (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

A.S.M.

ign-Off) vision S (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number. K121755

Kelyniam Customized Craniofacial Implant (CCI) K121755 - PEEK-OPTIMA-LT® (IFU)

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).