(45 days)
Not Found
No
The device description and intended use focus on the material composition and biological function of a bone void filler, with no mention of AI or ML technologies.
Yes
The device is described as a "bone void filler" that "resorbs and is replaced with bone during the healing process," indicating its therapeutic purpose in aiding bone repair.
No
Explanation: The device, NovaBone Putty, is described as a "bone void filler" and an "osteoconductive, bioactive, bone void filler device" that is "replaced with bone during the healing process." Its purpose is to fill bony voids and facilitate healing, not to diagnose a condition.
No
The device description clearly states it is a physical material (putty) composed of particulate and a binder, intended for implantation as a bone void filler. This is a hardware device, not software.
Based on the provided information, NovaBone Putty is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that NovaBone Putty is a bone void filler for bony voids or gaps in the skeletal system. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details the composition and mechanism of action as a material that is implanted and resorbed, replaced by bone. This is consistent with a medical device used for treatment or repair, not for diagnosing a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) outside of the body to provide diagnostic information.
- Anatomical Site: The device is applied directly to the skeletal system, which is an in-vivo application, not an in-vitro one.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. NovaBone Putty does not fit this description.
N/A
Intended Use / Indications for Use
NovaBone Putty -- Bioactive Synthetic Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. 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
MQV
Device Description
NovaBone Putty is an osteoconductive, bioactive, bone void filler device. It is composed of a calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles are slowly absorbed and replaced by new bone tissue during the healing process.
The primary component of NovaBone Putty is identical to the bioactive glass (45S5 Bioglass) particulate found in the NovaBone predicate. This synthetic material is both biocompatible and osteoconductive. The NovaBone Putty includes a synthetic binder as an inert carrier for ease of handling and delivery, forming a premixed cohesive material. The binder is biocompatible and is absorbed after implantation, opening space between the bioactive glass particles for cell infiltration and bone formation. The bioactive glass particulate remains for a longer post-implantation period, acting as a scaffold for bone ingrowth. This particulate is absorbed and replaced by new bone tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. the extremities and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians familiar with bone grafting and internal/external fixation techniques
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
In vivo performance data were presented. Additional supporting in vitro data were supplied.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image shows the date "MAY 1 2006". The month is "MAY", the day is "1", and the year is "2006". The text is in a simple, sans-serif font and is left-aligned.
Image /page/0/Picture/1 description: The image shows the logo for "NOVABONE SYNTHETIC BONE GRAFT PRODUCTS". The word "NOVABONE" is in large, bold, black letters. Below that, in smaller letters, are the words "SYNTHETIC BONE GRAFT PRODUCTS".
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The characters are 'K 060728'. The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with the 'K' having a distinct shape and the '8' having a loop at the top.
510(k) Summary NovaBone Putty - Bioactive Synthetic Graft
03/15/06
1. Submitter Information:
| Name: | NovaBone Products, LLC |
|---|---|
| Address: | 13709 Progress Boulevard, #33 |
| Alachua, FL 32615 | |
| Telephone: | (386) 462-7660 |
| Facsimile: | (386) 418-1636 |
| Contact: | David M. Gaisser |
2. Name of Device:
| Trade Name: | NovaBone Putty - Bioactive Synthetic Graft |
|---|---|
| Common Name: | Osteoconductive Bone Void Filler |
| Synthetic Resorbable Bone Graft Material | |
| Classification Name: | Unknown |
Legally Marketed Predicate Device: 3.
| Predicate #1: | NovaBone -- Resorbable Bone Graft Substitute - |
|---|---|
| [K021336] | |
| Predicate #2: | Exactech Resorbable Bone Paste - [K020078] |
| Predicate #3: | Grafton DBM - [K051195] |
4. Device Description
NovaBone Putty is an osteoconductive, bioactive, bone void filler device. It is composed of a calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles are slowly absorbed and replaced by new bone tissue during the healing process.
5. Intended Use
NovaBone Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and These defects may be surgically created osseous defects or osseous pelvis). 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.
1
Technological Characteristics ర్.
The technological characteristics of the NovaBone Putty device are similar to those of the predicates. The device and the predicates are designed as osteoconductive space-filling devices to be gently packed into defect sites and used as non-structural scaffolds for the body's natural healing and bone regeneration process. The device indications are the same as for the predicates.
The primary component of NovaBone Putty is identical to the bioactive glass (45S5 Bioglass) particulate found in the NovaBone predicate. This synthetic material is both biocompatible and osteoconductive. The NovaBone Putty includes a synthetic binder as an inert carrier for ease of handling and delivery, forming a premixed cohesive material. The binder is biocompatible and is absorbed after implantation, opening space between the bioactive glass particles for cell infiltration and bone formation. The bioactive glass particulate remains for a longer post-implantation period, acting as a scaffold for bone ingrowth. This particulate is absorbed and replaced by new bone tissue.
7. Warnings and Precautions
NovaBone Putty does not possess sufficient mechanical strength to support loadbearing defects prior to hard tissue ingrowth. In cases of fracture fixation or where load support is required, standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes.
NovaBone Putty is intended for use by clinicians familiar with bone grafting and internal/external fixation techniques. NovaBone Putty must not be used to gain screw purchase or to stabilize screw placement.
8. Complications
Possible complications are the same as to be expected of autogenous bone grafting procedures. These may include: superficial wound infection, deep wound infection, deep wound infection with osteomyelitis, delayed union, loss of reduction, failure of fusion, loss of bone graft, graft protrusion and / or dislodgement, and general complications that may arise from anesthesia and / or surgery.
9. Conclusion
NovaBone Putty is claimed to be substantially equivalent to the NovaBone. Exactech Resorbable Bone Paste, and Grafton DBM predicate devices as a nonstructural osteoconductive bone void filler for osseous defects. In vivo performance data were presented. Additional supporting in vitro data were supplied.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2006
NovaBone Products, LLC c/o Mr. David M. Gaisser VP, Operations/RA/QA 13709 Progress Boulevard #33 Alachua, Florida 32615
Re: K060728
Trade/Device Name: NovaBone Putty - BioActive Synthetic Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Bone Void Filler Regulatory Class: Class II Product Code: MQV Dated: March 15, 2006 Received: March 17, 2006
Dear Mr. Gaisser:
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 (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.
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Page 2 - Mr. David M. Gaisser
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 yours,
Hubert Lerner wo
for
L
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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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _______________________________________ NovaBone Putty II - Bioactive Synthetic Graft
Indications For Use:
NovaBone Putty -- Bioactive Synthetic Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. 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.
Prescription Use _ XX _
OR (Per 21 CFR 801.109) 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)
Hulut Lemer 10
Division of General, Restorative, and Neurological Devices
510(k) Number K060728