(15 days)
Norian SRS Fast Set Putty is indicated only for filling bony voids or gaps that are not intrinsic to the stability of the bony structure. The putty is to be gently packed into bony voids or gaps of the skeletal system including the extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SRS Fast Set Putty provides a bone void filler that resorbs and is replaced with bone during the healing process.
Norian SRS Fast Set Putty is a self-setting calcium phosphate cement characterized by a rapid in situ setting time. The Fast Set Putty components are supplied sterile in two separate containers. The putty is intraoperatively prepared by manually mixing the components within a cup using a spatula. Once complete, the putty can be shaped and contoured by hand.
The provided text is a 510(k) summary for the Norian SRS® Fast Set Putty, a medical device. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically described for AI/ML devices or diagnostic accuracy studies.
The document is a premarket notification to the FDA, demonstrating substantial equivalence to previously marketed devices. It confirms the device's classification, describes its components and indications for use, and states that documentation was provided to show substantial equivalence. There is no information regarding a study with a test set, ground truth, expert review, or statistical performance metrics.
Therefore, I cannot provide the requested information in the table format or specific details about a study, as such a study is not described or referenced in the provided text. The context of this document is a regulatory submission for a physical medical device (bone void filler) based on substantial equivalence, not an AI/ML algorithm or a diagnostic test with performance criteria.
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| 3. | 510(k) Summary: |
|---|---|
| ---- | ----------------- |
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
|---|---|
| Contact: | Sheri L. Musgnung |
| Device Name: | Norian SRS® Fast Set Putty |
| Device Classification: | 21 CFR 888.3045 - "Resorbable Calcium Salt Bone Void FillerDevice" |
| Predicate Device: | Norian SRS Bone Void Filler, K011897Norian CRS Fast Set Putty, K012589 |
| Description of Device: | Norian SRS Fast Set Putty is a self-setting calcium phosphate cementcharacterized by a rapid in situ setting time. The Fast Set Puttycomponents are supplied sterile in two separate containers. The puttyis intraoperatively prepared by manually mixing the componentswithin a cup using a spatula. Once complete, the putty can be shapedand contoured by hand. |
| Indications: | Norian SRS Fast Set Putty is indicated only for filling bony voids orgaps that are not intrinsic to the stability of the bony structure. Theputty is to be gently packed into bony voids or gaps of the skeletalsystem including the extremities, spine, and pelvis. These defects maybe surgically created osseous defects or osseous defects created fromtraumatic injury to the bone. SRS Fast Set Putty provides a bone voidfiller that resorbs and is replaced with bone during the healing process. |
| Material: | Calcium Phosphate |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Norian SRSFast Set Putty is substantially equivalent to other legally marketeddevices. |
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Image /page/1/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2004
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, PA 19301
Re: K041842
Norian SRS Fast Set Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: July 7, 2004 Received: July 8, 2004
Dear Ms. Musgnung:
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 the Federal I 600 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 ( . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
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Page 2 - Ms. Sheri L. Musgnung
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) rins reter intification. 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), r you don't the Office of Compliance at (301) 594-4659. 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 maj overnment 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,
Mark N. Millkern
Celia M. Witten, Ph.D., M.D. 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
Page 1 of 1
Ko411842
510(k) Number (if known):
Device Name:
Indications for Use:
Norian SRS® Fast Set Putty
Norian SRS Fast Set Putty is indicated only for filling bony voids or gaps that are not intrinsic to the stability of the bony structure. The putty is to be gently packed into bony voids or gaps of the skeletal system including the extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SRS Fast Set Putty provides a bone void filler that resorbs and is replaced with bone during the healing process.
Prescription Use
(Per 21 CFR 801.109)
510(k) N
OR
Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices |
| K041842 | 000004 |
|---|---|
| --------- | -------- |
§ 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.