The Cranion™ Cranial Fixation System intended for reconstruction of the craniomaxillofacial skeleton and for reattachment of cranial bone flaps after craniotomy procedures. The system is used to align and stabilized bony tissue while normal healing occurs. Each implantable component is intended for single use only and may be combined only with other titanium and titanium alloy implants.

Device Description

The Cranion™ Cranial Fixation System includes a variety of plate configurations for different anatomical applications. Titanium alloy plates, and titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue. Titanium alloy clamps and clips are included for the reattachment of cranial bone flaps after craniotomy procedures.

AI/ML Overview

This submission (K051293) is for a Cranion™ Cranial Fixation System, a medical device used for cranial and maxillofacial surgery. The FDA has found the device to be substantially equivalent to legally marketed predicate devices. This means that the device meets the safety and effectiveness criteria that generally apply to similar devices already on the market.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Details
Substantial Equivalence	Device characteristics are substantially equivalent to predicate devices, and any minor differences raise no new safety/efficacy issues.	The Cranion™ Cranial Fixation System has the same indications for use as the predicate devices. All technical characteristics are substantially equivalent to corresponding characteristics of predicate devices.	The FDA reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the comparison provided in the submission, which includes the intended use and technical characteristics.
Intended Use	Intended for reconstruction of the craniomaxillofacial skeleton and for reattachment of cranial bone flaps after craniotomy procedures. The system is used to align and stabilize bony tissue while normal healing occurs.	The reported intended use of the Cranion™ Cranial Fixation System is identical to this criterion.	The submission explicitly states the intended use of the device.
Material/Components	Each implantable component is intended for single-use only and may be combined only with other titanium and titanium alloy implants.	The reported material and component conditions for Cranion™ Cranial Fixation System are identical to this criterion.	The submission explicitly states these conditions.

Study Information

Based on the provided text, the submission (K051293) is a 510(k) Premarket Notification. This type of submission generally relies on demonstrating substantial equivalence to predicate devices rather than conducting a new, comprehensive clinical study to prove the device meets novel acceptance criteria.

Therefore, many of the requested study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set) are not applicable in the context of this 510(k) submission, as it does not describe a clinical trial or performance study as typically understood for new device approvals. Instead, the "study" is a comparative analysis demonstrating substantial equivalence to pre-existing, legally marketed devices.

Here's why some points are not present:

1. A table of acceptance criteria and the reported device performance: This is addressed above by framing "substantial equivalence" and "intended use" as the primary acceptance criteria for a 510(k) and comparing the device's described attributes to these.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific test set or data from a clinical study for K051293 is described. The "test set" is, in essence, the comparison of the device's specifications and intended use against those of the predicate devices.
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. "Ground truth" in this context refers to the established safety and efficacy of the predicate devices, as determined by prior FDA approvals and market experience.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a cranial fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a cranial fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate devices. The FDA's initial approval of those predicate devices would have relied on various forms of evidence, potentially including expert consensus, non-clinical tests, and prior clinical experience.
8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable.

In summary, the "study" that proves the device meets the acceptance criteria is the 510(k) submission process itself, which involves a detailed comparison of the Cranion™ Cranial Fixation System to a list of predicate devices from Bioplate, Inc. The acceptance criteria are primarily substantial equivalence in intended use and technical characteristics, leading to no new safety or efficacy issues.

Summary

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K051293
Ceremed, Inc.	Page 7 - 1
510 (k) Premarket Notification - Cranion™ Cranial Fixation System

VII - 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS: Submitted by:

Tadeusz Wellisz, M.D. Ceremed, Inc. 3643 Lenawee Ave. Los Angeles, California 90016 Tel: (310) 815-2125 Fax: (310) 815-2130

JUN 1 4 2005

Contact Person:	Tadeusz Wellisz, M.D.
Date Prepared	May 12, 2005
Common/Usual Name:	Bone Plate, cranioplasty preformed, non-alterable
Proprietary Names:	Cranion™ Cranial Fixation System, FixLock™, Cranial Solutions, Ceremed™ Fixation System

Classification Name:

Bone Plate, cranioplasty preformed, non-alterable

Predicate Devices

1. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K023810
1. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K021684
1. Bioplate, Inc. Zip Craniotomy Fixation System K020880
1. Bioplate, Inc. Bioclip Craniotomy Fixation System K013055
1. Bioplate, Inc. Zip Craniotomy Fixation System K013050
1. Bioplate, Inc. Bioclip Craniotomy Fixation System K011380
1. Bioplate, Inc.

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Fixation System for Craniomaxillofacial Surgery K992330

1. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K972463
1. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K953273
1. Bioplate, Inc. Fixation System for Craniomaxillofacial Surgery K943071

Description of the device:

Intended use:

Substantial equivalence:

The Cranion™ Cranial Fixation System has the same indications for use as the predicate devices marketed by Bioplate, Inc. All of the technical characteristics of The Cranion™ Cranial Fixation System are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2005

Dr. Tadeusz Wellisz President Ceremed, Incorporated 3643 Lenawee Avenue Los Angeles, California 90016

Re: K051293

Trade/Device Name: Cranion™ Cranial Fixation System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 2, 2005 Received: June 6, 2005

Dear Dr. Wellisz:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Dr. Wellisz

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jenette y- Michael ms

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 10 - 1

510 (k) Premarket Notification - Cranion™ Cranial Fixation System

X. INDICATIONS FOR USE:

K051293 510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________ Device Name: Cranion™ Cranial Fixation System

Indications For Use:

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EV ALUATION (ODE)

X Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Susan Rivas

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental

510(k) Number:_

Division Sign-Off

510(k) Number

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.