(51 days)
Not Found
Not Found
No
The device description and intended use focus on 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 described as "bone cement" used for "augmentation and restoration of the craniofacial skeleton," indicating its therapeutic purpose to repair or improve biological function.
No
The device description indicates it is a moldable bone cement used for filling defects and augmenting bone contours, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a moldable, thermally activated, biocompatible bone cement supplied as a powder and solution, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that Norian CRS Fast Set Putty is a "moldable, thermally activated, biocompatible bone cement" intended for filling and augmenting bony defects in the craniofacial skeleton. It is a material implanted into the body, not used to test samples taken from the body.
- Intended Use: The intended use is for "filling craniofacial defects in the restoration or augmentation of bony contours." This is a surgical or reconstructive procedure, not a diagnostic test.
Therefore, Norian CRS Fast Set Putty falls under the category of a surgical or implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Norian CRS Fast Set Putty 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 Fast Set Putty is not intended for use in the spine and should not be used in the presence of active or suspected infection.
Product codes
GXP
Device Description
Norian CRS Fast Set Putty is a moldable, thermally activated, biocompatible bone cement. Norian CRS Fast Set Putty is supplied in two containers: one container holds sterile powder (calcium phosphate) and the second container holds sterile solution (dilute sodium phosphate). When the powder and solution are mixed together with the provided cup and spatula, the resultant putty material is suitable for augmentation and restoration of the craniofacial skeleton. When fully cured, the composition formed closely approximates the mineral phase of bone. Norian CRS Fast Set Putty is gradually remodeled over time. 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized design. A registered trademark symbol is located to the right of the word.
K060443
3. 510(k) Summary
| Sponsor: | Synthes (USA)
1302 Wrights Lane East
West Chester, PA 19380 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Angela J. Silvestri
(484) 356-9728 |
| Device Name: | Norian CRS Fast Set Putty |
| Device Classification: | 21 CFR 882.5300 - Methyl methacrylate for cranioplasty |
| Device Description: | Norian CRS Fast Set Putty is a moldable, thermally activated,
biocompatible bone cement. Norian CRS Fast Set Putty is supplied in
two containers: one container holds sterile powder (calcium
phosphate) and the second container holds sterile solution (dilute
sodium phosphate). When the powder and solution are mixed together
with the provided cup and spatula, the resultant putty material is
suitable for augmentation and restoration of the craniofacial skeleton.
When fully cured, the composition formed closely approximates the
mineral phase of bone. Norian CRS Fast Set Putty is gradually
remodeled over time. This material is provided sterile and is for
single use only. |
| Indications for use: | Norian CRS Fast Set Putty 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 Fast Set Putty is not intended for use in the spine and
should not be used in the presence of active or suspected infection. |
| | Predicate Device |
| 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 consists of a circular seal with the text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of three abstract human figures connected at the base.
APR 1 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) c/o Angel Silvestri Group Manager, Regulatory Affairs 1230 Wilson Drive West Chester, Pennsylvania 19380
Re: K060443
Trade/Device Name: Norian CRS Fast Set Putty 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 10 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 (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.
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.
. Mall
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- Indications for Use Statement
| Page | 1 of 1 |
|---|---|
| 510(k) Number (if known): | |
| Device Name: | Norian CRS Fast Set Putty |
| Indications For Use: |
Norian CRS Fast Set Putty 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 Fast Set Putty is not intended for use in the spine and should not be used in the presence of active or suspected infection.
Over-The-Counter Use Use Prescription × — AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qgmall
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K060443 510(k) Number_