(32 days)
Not Found
No
The 510(k) summary describes a calcium phosphate cement used as a bone void filler. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The device is a physical material.
Yes
The device, Norian SRS Fast Set Putty, is a bone void filler intended to facilitate the healing process by being replaced with bone. This function directly contributes to the restoration or improvement of a physiological function, which aligns with the definition of a therapeutic device.
No
The device description indicates that Norian SRS Fast Set Putty is a bone void filler intended for structural support and bone regeneration, not for diagnosing conditions.
No
The device description clearly states it is a self-setting calcium phosphate cement supplied with physical components (containers, mixing cup, spatula) and is a material intended for surgical implantation, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Norian SRS Fast Set Putty is a bone void filler for bony defects in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details a self-setting calcium phosphate cement that is mixed and applied directly to bone. This is a physical material used for repair and regeneration, not a reagent or instrument used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens. Norian SRS Fast Set Putty is used in vivo (inside the body) as a medical implant/material.
N/A
Intended Use / Indications for Use
Norian SRS Fast Set Putty is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Fast Set Putty is intended to be placed into bony voids or gaps of the skeletal system (the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
Norian SRS Fast Set Putty is a self-setting calcium phosphate cement. SRS Fast Set Putty components are supplied sterile in two separate containers. It is prepared for use by manually mixing two components within a cup using a spatula. The mixing cup and spatula are included in the device packaging. Once combined into a uniform consistency, the product can be shaped and contoured by hand. Norian SRS Fast Set Putty is gradually resorbed 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
skeletal system (the extremities and pelvis)
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.
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
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
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K 060406
3. 510(k) Summary
MAR 2 0 2006
| Sponsor: | Synthes (USA)
1302 Wrights Lane East
West Chester, PA 19380 |
|--------------|-------------------------------------------------------------------------------------------------------|
| Contact: | Angela J. Silvestri
Synthes (USA)
1230 Wilson Drive
West Chester, PA 19380
(484) 356-9728 |
| Device Name: | Norian SRS Fast Set Putty |
Device Classification: 87 MQV - Class II - Filler, Bone Void, Calcium Compound
Device Description: Norian SRS Fast Set Putty is a self-setting calcium phosphate cement. SRS Fast Set Putty components are supplied sterile in two separate containers. It is prepared for use by manually mixing two components within a cup using a spatula. The mixing cup and spatula are included in the device packaging. Once combined into a uniform consistency, the product can be shaped and contoured by hand. Norian SRS Fast Set Putty is gradually resorbed over time. This material is provided sterile and is for single use only.
Indications for use: Norian SRS Fast Set Putty is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Fast Set Putty is intended to be placed into bony voids or gaps of the skeletal system (the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Norian SRS 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 Norian SRS Fast Set Putty, K041842
Substantial Equivalence This device is equivalent to the predicate in terms of material Determination composition, physical properties, and performance characteristics.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. Encircling the caduceus are the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA". The text is arranged in a circular fashion around the symbol.
MAR 2 0 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) c/o Ms. Angela J. Silvestri Group Manager, Regulatory Affairs 1230 Wilson Drive West Chester, Pennsylvania 19380
Re: K060406
Trade/Device Name: Norian SRS Fast Set Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: February 15, 2006 Received: February 16, 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
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Page 2 – Ms. Angela J. Silvestri
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) 276-0120. 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/dsma/dsmamain.html
Sincerely yours,
Herbert Lehman
Mark N. Melkerson Acting 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
KO60406 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ________ Norian SRS Fast Set Putty
Indications For Use:
Norian SRS Fast Set Putty is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Fast Set Putty is intended to be placed into bony voids or gaps of the skeletal system (the extremittes and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Contraindications:
Norian SRS Fast Set Putty is not intended for use in the spine and should not be used in the presence of active or suspected infection
Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR
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 Deyice Evaluation (ODE)
Usted Lewis
Division of General, Restorative, and Neurological Devices
510(k) Number_
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