(128 days)
Not Found
No
The description focuses on the material properties and delivery mechanisms of a bone void filler, with no mention of AI or ML.
Yes
The device is described as a "bone void filler" that "resorbs and is replaced with bone during the healing process" and acts as a "temporary support medium," indicating its function in facilitating the healing of bony defects.
No
Explanation: The provided text describes Norian Drillable Inject and Norian Drillable Fast Set Putty as bone void fillers intended to be placed into bony voids or defects. The device description focuses on its physical properties, how it's prepared and used, and its role in supporting bone fragments and being replaced by bone during healing. There is no mention of the device being used to diagnose conditions or collect diagnostic information.
No
The device description clearly details a physical bone void filler material (putty/paste) and associated hardware (syringes, mixer, cup, spatula). There is no mention of software as a component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "bone void filler" for bony defects in the extremities and pelvis. It is used in vivo (within the body) to support bone fragments and provide a matrix for bone growth.
- Device Description: The description details a material that is mixed and placed into the body to set and be resorbed. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples from the body (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for health issues.
IVD devices are used in vitro (outside the body) to examine specimens obtained from the human body. This device is used in vivo to treat a physical defect.
N/A
Intended Use / Indications for Use
Norian Drillable Inject and Norian Drillable Fast Set Putty are intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. 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 Drillable Inject and Norian Drillable Fast Set Putty can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable Inject and Norian Drillable Fast Set Putty are intended to be placed into bony voids either before or after final fixation.
Product codes (comma separated list FDA assigned to the subject device)
MQV, OIS
Device Description
Norian Drillable Inject and Norian Drillable Fast Set Putty are moldable, biocompatible bone void fillers with added reinforcing fibers. Norian Drillable Inject and Norian Drillable Fast Set Putty are intended to be placed into bony voids or defects of the extremities or pelvis either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during or after 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 Drillable Inject is an injectable paste that is mixed with an automatic mixer, and Norian Drillable Fast Set Putty is manually mixed with a cup and spatula.
Norian Drillable Inject is provided in a sterile pouch (the "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 powder with fibers and is designed with an injection port for the purpose of adding the mixing solution to the pouch. The mixing solution is contained in the Solution Syringe, which is packaged separately.
The Rotary Pouch is designed to be placed in a reusable mixer (the “Rotary Mixer”) 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 Drillable Inject begins to harden after 2 minutes and sets in approximately 10 minutes. Norian Drillable Inject is slowly resorbed over a period of years and replaced with bone during the healing process.
Norian Drillable 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 Drillable Fast Set Putty begins to harden after 2 minutes and sets in approximately 3 to 6 minutes. Norian Drillable Fast Set Putty is slowly resorbed over a period of years and replaced with bone during the healing process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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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JAN 2 7 2011
Page 2
| 2. 510(k) Summary | |
|---|---|
| Sponsor: | Synthes Biomaterials |
| 1230 Wilson Drive | |
| West Chester, PA 19380 | |
| Company Contact | Jeffrey L. Dow, JD |
| Director, Clinical & Regulatory Affairs | |
| Synthes Biomaterials | |
| 484 356 9720 | |
| dow.jeff@synthes.com | |
| Device Name: | Norian Drillable™ Inject and Norian Drillable™ Fast Set |
| Putty™ | |
| Classification: | Class II, 21 CFR §888.3045 |
| Filler, bone void, calcium compounds. | |
| Product Codes | MQV, OIS |
| Predicate Devices | Norian SRS Bone Void Filler and Norian SRS Fast Set Putty |
| (K073303) | |
| Device Description: | Norian Drillable Inject and Norian Drillable Fast Set Putty are |
| moldable, biocompatible bone void fillers with added | |
| reinforcing fibers. Norian Drillable Inject and Norian Drillable | |
| Fast Set Putty are intended to be placed into bony voids or | |
| defects of the extremities or pelvis either before or after final | |
| fixation. The material can be drilled and tapped, and screws can | |
| be placed through it at any time during or after 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 | |
| Drillable Inject is an injectable paste that is mixed with an | |
| automatic mixer, and Norian Drillable Fast Set Putty is | |
| manually mixed with a cup and spatula. | |
| Norian Drillable Inject is provided in a sterile pouch (the | |
| "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 | |
| powder with fibers and is designed with an injection port for the | |
| purpose of adding the mixing solution to the pouch. The | |
| mixing solution is contained in the Solution Syringe, which is |
2
1
Image /page/1/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 design inside. A registered trademark symbol is located to the right of the word.
.
। : packaged separately.
:
| | The Rotary Pouch is designed to be placed in a reusable mixer
(the “Rotary Mixer”) 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 Drillable Inject
begins to harden after 2 minutes and sets in approximately 10
minutes. Norian Drillable Inject is slowly resorbed over a
period of years and replaced with bone during the healing
process. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Norian Drillable 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 Drillable Fast Set
Putty begins to harden after 2 minutes and sets in approximately
3 to 6 minutes. Norian Drillable Fast Set Putty is slowly
resorbed over a period of years and replaced with bone during
the healing process. |
| Intended Use: | Norian Drillable Inject and Norian Drillable Fast Set Putty are
intended for bony voids or defects of the extremities and pelvis
that are not intrinsic to the stability of the bony structure. 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 Drillable Inject and
Norian Drillable Fast Set Putty can be used as an adjunct to
conventional rigid hardware fixation by supporting the bone
fragments during the surgical procedure. Once the material has
set, it acts as a temporary support medium and is not intended to
provide structural support during the healing process. Norian
Drillable Inject and Norian Drillable Fast Set Putty are intended
to be placed into bony voids either before or after final fixation. |
| Substantial
Equivalence: | Documentation is provided that demonstrates that Norian
Drillable is substantially equivalent to other legally marketed
devices. |
4 The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) c/o Mr. Jeffrey L. Dow, JD Director, Clinical and Regulatory Affairs, Biomaterials 1230 Wilson Drive West Chester, PA 19380
JAN 2 7 2011
Re: K102722
Device Name: Norian Drillable Inject and Norian Drillable Fast Set Putty Regulation Number: 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: Class II Product Code: MQV, OIS Dated: January 14, 2011 Received: January 18, 2011
Dear Mr. Dow:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 -- Mr. Jeffrey L. Dow, JD
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 1000-10501-0
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/CDRHOffices/uccn11158001/jphf 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 (11 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 vours
R. N. Mallekson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized letter inside of a circle. A small circle is located to the right of the word, likely indicating a registered trademark. The text and logo are centered on a white background.
ﺬ ﺳﻴﻨ
1. Indications for Use Statement
Norian Drillable Inject and Norian Drillable Fast Set Putty are intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. 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 Drillable Inject and Norian Drillable Fast Set Putty can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable Inject and Norian Drillable Fast Set Putty are intended to be placed into bony voids either before or after final fixation.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Lounne M. Bugar
(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102722