NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY by SYNTHES USA PRODUCTS LLC

Norian Reinforced and Norian Reinforced Fast Set Putty are indicated for repairing or filling cranial defects and craniotomy cuts with a surface area no larger than 25 cm '. Norian Reinforced and Norian Reinforced Fast Set Putty are also indicated for the restoration or augmentation of bony contours of the cranial skeleton (including frontoorbital areas) such as burr hole voids and other cranial defects.

Device Description

Norian Reinforced and Norian Reinforced Fast Set Putty (FSP) are moldable, biocompatible bone cements with added reinforcing fibers. Norian Reinforced and Norian Reinforced FSP are intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton. The material resists cracking during the setting process. When fully cured, the composition formed closely approximates the mineral phase of bone.

The product is available in two delivery forms. Norian Reinforced is an injectable paste that is mixed with an automatic mixer, and Norian Reinforced Fast Set Putty is manually mixed with a cup and spatula.

Norian Reinforced is provided in a sterile pouch ("Rotary Pouch"). The Rotary Pouch is constructed of a clear-film outer pouch and a foil laminate inner pouch with an attached delivery syringe. The Rotary Pouch contains sterile powderpurpose of adding the mixing solution to the pouch. The mixing solution is contained in the Solution Syringe that is

The Rotary Pouch is designed to be placed in an automatic reusable mixer outside the sterile field where the two components are mixed together to form a smooth, viscous paste. The paste remains injectable for approximately 5 minutes at 18°-23°C / 64°-73°F. At body temperature (37°C / 98.6°F), Norian Reinforced begins to harden after 2 minutes and sets in approximately 10 minutes.

Norian Reinforced is slowly resorbed over a period of years and replaced with bone during the healing process.

Norian Reinforced Fast Set Putty is supplied in two containers. The mixing cup holds sterile powder with fibers and the solution syringe holds sterile solution. When the powder and solution are mixed together with the provided cup and spatula, the resultant putty material can be manipulated for two minutes at 18°-23°C / 64°-73°F.

At body temperature (37°C / 98.6°F), Norian Reinforced Fast Set Putty begins to harden after 2 minutes and sets in approximately 3 to 6 minutes. Norian Reinforced Fast Set Putty is slowly resorbed over a period of years and replaced with bone during the healing process.

AI/ML Overview

Here's an analysis based on the provided 510(k) summary for Norian Reinforced and Norian Reinforced Fast Set Putty:

Key Takeaway: This 510(k) summary is for a medical device (bone cement), not an AI/ML powered device. Therefore, many of the requested sections related to AI/ML specific evaluation criteria (e.g., sample sizes for test and training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this document. The "study" here refers to a comparative non-clinical study against predicate devices, focusing on material properties and biocompatibility.

Acceptance Criteria and Study Details (Non-AI/ML Medical Device)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a bone cement, the "acceptance criteria" are related to its physical properties, biocompatibility, and intended use as compared to predicate devices. The document doesn't provide specific quantitative tables for acceptance criteria and performance values in the way one would for an AI model. Instead, it states that the device meets the requirements through comparative testing.

Acceptance Criterion Type	Reported Device Performance
Mechanical Properties	Equivalent to predicate Norian products.
In Vitro Performance	Equivalent to predicate Norian products.
Biocompatibility	Passed relevant tests specified in ISO 10993; equivalent to predicate Norian products.
Setting Time (Norian Reinforced)	Remains injectable for approx. 5 min (18-23°C); hardens after 2 min, sets in approx. 10 min (37°C).
Setting Time (Norian Reinforced Fast Set Putty)	Manipulable for 2 min (18-23°C); hardens after 2 min, sets in approx. 3-6 min (37°C).
Resorption/Replacement	Slowly resorbed over years and replaced with bone during healing process (for both products).
Indicated Use Match	Indicated for repairing or filling cranial defects and craniotomy cuts with a surface area no larger than 25 cm², and restoration/augmentation of bony contours of cranial skeleton (including fronto-orbital areas, burr hole voids, other cranial defects) - matching predicate's use.

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

Sample Size: Not specified in the provided summary. This would refer to the number of material samples tested for mechanical, in-vitro, and biocompatibility assessments.
Data Provenance: Not specified, but generally, such tests are conducted in laboratories following specific standards (e.g., ISO, ASTM). The data would be from controlled laboratory experiments, not patient data.

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

Not Applicable. This is a medical device (bone cement) undergoing non-clinical testing for material properties and biocompatibility, not an AI/ML system requiring expert-based ground truth on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not Applicable. As above, this doesn't involve subjective human interpretation or diagnostic agreement typical of AI/ML evaluation. Performance is based on objective measurements against established material standards and comparisons to predicate devices.

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

No. This is a bone cement, not an imaging AI diagnostic aid. MRMC studies are not relevant for this type of device.

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

Not Applicable. This is a physical medical device (bone cement), not an algorithm.

7. The Type of Ground Truth Used

Objective Material Science and Biocompatibility Standards: The "ground truth" for this device's performance is based on established scientific and engineering principles for material properties (e.g., strength, setting time), chemical composition, and biological response as defined by recognized standards (e.g., ISO 10993 for biocompatibility). The comparison point is often the performance of the predicate device.

8. The Sample Size for the Training Set

Not Applicable. This is a medical device, not an AI/ML model that requires a training set. The device formulation and manufacturing process are developed through R&D and engineering, not machine learning training.

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

Not Applicable. As with point 8, there is no "training set" in the context of an AI/ML model for this type of device.

Summary

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510(k) Summary	K102018
Sponsor:	Synthes Biomaterials1230 Wilson DriveWest Chester, PA 19380
CompanyContact	Jeffrey L. Dow, JDDirector, Clinical & Regulatory AffairsSynthes Biomaterials484 356 9720dow.jeff@synthes.com	SEP	23 2010
Date SummaryPrepared	August 25, 2010
Device Name:	Norian Reinforced™ and Norian Reinforced Fast Set Putty™
Classification:	Class II, 21 CFR §882.5300Methyl Methacrylate for Cranioplasty
Product Code	GXP
PredicateDevices:	Norian CRS Bone Cement (973789)Norian CRS Fast Set Putty (K012589)
DeviceDescription:	Norian Reinforced and Norian Reinforced Fast Set Putty(FSP) are moldable, biocompatible bone cements with addedreinforcing fibers. Norian Reinforced and Norian ReinforcedFSP are intended for filling craniofacial defects in therestoration or augmentation of bony contours of thecraniofacial skeleton. The material resists cracking during thesetting process. When fully cured, the composition formedclosely approximates the mineral phase of bone.
	The product is available in two delivery forms. NorianReinforced is an injectable paste that is mixed with anautomatic mixer, and Norian Reinforced Fast Set Putty ismanually mixed with a cup and spatula.
	Norian Reinforced is provided in a sterile pouch ("RotaryPouch"). The Rotary Pouch is constructed of a clear-filmouter pouch and a foil laminate inner pouch with an attacheddelivery syringe. The Rotary Pouch contains sterile powderpurpose of adding the mixing solution to the pouch. Themixing solution is contained in the Solution Syringe that is

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Norian Reinforced is slowly resorbed over a period of years and replaced with bone during the healing process.

The results from mechanical and in vitro comparative testing demonstrate that Norian Reinforced Products are equivalent to the predicate Norian products previously identified. The material has been tested for safety following the biocompatibility standards set forth in ISO 10993. This testing demonstrates that Norian Reinforced Products pass the relevant tests specified, as did the predicates.

Intended Use:

Norian Reinforced and Norian Reinforced Fast Set Putty are indicated for repairing or filling cranial defects and craniotomy cuts with a surface area no larger than 25 cm2. Norian Reinforced and Norian Reinforced Fast Set Putty are also indicated for the restoration or augmentation of bony contours of the cranial skeleton (including fronto-orbital areas) such as burr hole voids and other cranial defects.

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Image /page/2/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

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

Synthes Biomaterials c/o Jeffrey L. Dow, JD Director, Regulatory & Clinical Affairs 1230 Wilson Drive West Chester, PA 19380

SEP 2 3 2010

Re: K102018

R102016
Trade/Device Name: Norian Reinforced™ and Norian Reinforced Fast Set PuttyTM Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: GXP Dated: July 14, 2010 Received: July 19, 2010

Dear Mr. Dow:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boousine is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass build in the 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 I ou may, merelors, mainer ato a Act include requirements for annual registration, listing of general oonlines provided of nactice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Thease noter 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 If your device is classified (bee acove) Existing major regulations affecting your device can be may be subject to additions, 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 Flease of advised that 1271 5 issuance or our device complies with other requirements of the Act that IDA has made a decommandia as administered by other Federal agencies. You must or any Federal slautes and regulations adminities. but not limited to: registration and listing (21 Comply with an the Act 3 requirements, and 801); medical device reporting (reporting of medical

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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,

Poth

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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1. Indications for Use

K102018 SEP 2 3 2010

510(k) Number (if known): K102018

Indications:

Prescription Use		AND/OR	Over-The-Counter Use
(Per 21 CFR 801 Subpart D)	X		(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mondulika Varmani 9/15/10

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_103018

Regulation Number and Section

§ 882.5300 Methyl methacrylate for cranioplasty.

(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).