(51 days)
Not Found
No
The description details a bone cement material and its physical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a bone cement used to fill bone defects, which is a restorative and therapeutic function.
No
The device description and intended use indicate that Norian CRS Bone Cement is used for filling and augmenting bony contours, and sets to become a hard material. It functions as a restorative material rather than a tool for diagnosis.
No
The device description clearly describes a physical bone cement product composed of powder and solution components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Norian CRS Bone Cement is for filling craniofacial defects in the restoration or augmentation of bony contours. This is a therapeutic and structural use, not a diagnostic one.
- Device Description: The description details a bone cement that is mixed and applied to the body to harden and provide structural support. This is a medical device used in vivo (within the body), not in vitro (outside the body) for diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting markers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Norian CRS Bone Cement does not fit this description.
N/A
Intended Use / Indications for Use
Norian CRS Bone Cement is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm2.
Norian CRS Bone Cement is not intended for use in the spine and should not be used in the presence of active or suspected infection.
Product codes (comma separated list FDA assigned to the subject device)
GXP
Device Description
Norian CRS Bone Cement is an injectable, moldable, and biocompatible bone cement. The Reactants Pack contains sterile powder (calcium phosphate) and a syringe that contains sterile solution (dilute sodium phosphate). The Reactants Pack is designed to be placed in a reusable mixer where the 2 components are mixed together to form a smooth, viscous paste that remains injectable for approximately 5 minutes at 18 -23°C / 64°- 73°F. At body temperature (37°C / 98.6°F), Norian CRS Cement begins to harden after 2 minutes and sets in approximately 10 minutes. Norian CRS Cement is slowly resorbed and replaced by bone over a period of years. This material is provided sterile and is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton (including fronto-orbital, malar, and mental areas)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Norian CRS Bone Cement K973789
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A registered trademark symbol is located to the upper right of the word.
3. 510(k) Summary
| Sponsor: | Synthes (USA)
1302 Wrights Lane East
West Chester, PA 19380 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Angela Silvestri
Synthes (USA)
1230 Wilson Drive
West Chester, PA 19380
(484) 356-9728 |
| Device Name: | Norian CRS Bone Cement |
| Device Classification: | 21 CFR 882.5300 - Methyl methacrylate for cranioplasty |
| Device Description: | Norian CRS Bone Cement is an injectable, moldable, and
biocompatible bone cement. The Reactants Pack contains sterile
powder (calcium phosphate) and a syringe that contains sterile
solution (dilute sodium phosphate). The Reactants Pack is designed to
be placed in a reusable mixer where the 2 components are mixed
together to form a smooth, viscous paste that remains injectable for
approximately 5 minutes at 18 -23°C / 64°- 73°F. At body temperature
(37°C / 98.6°F), Norian CRS Cement begins to harden after 2 minutes
and sets in approximately 10 minutes. Norian CRS Cement is slowly
resorbed and replaced by bone over a period of years. This material is
provided sterile and is for single use only. |
| Indications for use: | Norian CRS Bone Cement is intended for filling craniofacial defects
in the restoration or augmentation of bony contours of the craniofacial
skeleton (including fronto-orbital, malar, and mental areas) such as
burr hole voids and other craniofacial defects, with a surface area no
larger than 25cm2.
Norian CRS Bone Cement is not intended for use in the spine and
should not be used in the presence of active or suspected infection. |
| Predicate Device | Norian CRS Bone Cement K973789 |
| Substantial Equivalence
Determination | This device is equivalent to the predicate in terms of material
composition, physical properties and performance characteristics. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol on the right, which is a staff with two snakes entwined around it. To the left of the caduceus, the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern.
Public Health Service
APR 1 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) c/o Ms. Angel Silvestri Group Manager, Regulatory Affairs 1230 Wilson Drive West Chester, Pennsylvania 19380
Re: K060445
Trade/Device Name: Norian CRS Bone Cement Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: GXP Dated: February 16, 2006 Received: February 23, 2006
Dear Ms. Silvestri:
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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Angel Silvestri
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) 276-0120 . 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 vours.
eMell
Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. There is a horizontal line underneath the word and logo.
2. Indications for Use Statement
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: __________ Norian CRS Bone Cement
Indications For Use:
Norian CRS Bone Cement is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm ..
Contraindications:
Norian CRS Bone Cement is not intended for use in the spine and should not be used in the presence of active or suspected infection.
Use Prescription X - AND/OR (Part 21 CFR 801 Subpart D) ·
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number_ K060445