(124 days)
Not Found
No
The document describes a bone void filler material and its intended use, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No.
The device is a bone void filler that resorbs and is replaced with bone during the healing process, operating as a physical osteoconductive material rather than directly treating a disease or condition.
No
This device is a bone void filler used for treatment, not for diagnosing conditions. It is described as an "osteoconductive, bioactive, bone void filler device" that "resorbs and is replaced with bone during the healing process."
No
The device description clearly states it is a physical material (putty) composed of particulate and a binder, intended for surgical implantation. It is a physical medical device, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that NovaBone Putty is a "bone void filler device" intended to be "gently packed into bony voids or gaps of the skeletal system." This is a device that is implanted directly into the body to aid in bone healing.
- No Mention of Samples or Testing: There is no mention of the device being used to test samples from the body or to provide diagnostic information.
Therefore, NovaBone Putty is a medical device used for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 extremitics, spine 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.
NovaBone Putty is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength to support load-bearing defects prior to hard tissue ingrowth. It should not be used for vertebroplasty or kyphoplasty procedures. 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. NoyaBone Putty must not be used to gain screw purchase or to stabilize screw placement.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
NovaBonc 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
the extremitics, spine 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Animal testing has demonstrated that the majority of the material is absorbed within six months of implantation, with >98% of the matcrial being absorbed by 12 months. The timeframe for full absorption in humans has not been determined, but is expected to be at least 12 months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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Image /page/0/Picture/0 description: The image shows the logo for "NOVABONE SYNTHETIC BONE GRAFT PRODUCTS". The logo is in a bold, sans-serif font. The word "NOVABONE" is in all caps and is the largest text in the image. Below the word "NOVABONE" is the phrase "SYNTHETIC BONE GRAFT PRODUCTS" in a smaller font.
Yosvoog9
510(k) Summary NovaBone Putty - Bioactive Synthetic Graft
12/31/07
1. Submitter Information:
| Name: | NovaBone Products, LLC | MAY - 6 2008 |
|---|---|---|
| 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 | |
| Regulation Number: | 21 CFR 888.3045 |
| Regulation Name: | Bone Void Filler |
3. Legally Marketed Predicate Device:
| Predicate #1: | NovaBone Putty - Bioactive Synthetic Graft -
[K060728] |
|---------------|---------------------------------------------------------------------|
| Predicate #2: | NovaBone - Resorbable Bone Graft Substitute -
[K021336, K052494] |
4. Device Description
NovaBonc 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, spinc 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.
NovaBone Putty is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength to support load-bearing defects prior to hard tissue ingrowth. It should not be used for vertebroplasty or kyphoplasty
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In cases of fracture fixation or where load support is required, procedures. standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes. NovaBone Putty must not be used to gain screw purchase or to stabilize screw placement.
Technological Characteristics 6.
The technological characteristics of the NovaBone Putty device are identical to the NovaBone Putty device cleared per K060728, which are in turn similar to those of the NovaBone predicate. The device and 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 device is intended to be used alone, or in combination with autogenous bone.
The primary component of NovaBone Putty is identical to the bioactive glass (4585 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. Animal testing has demonstrated that the majority of the material is absorbed within six months of implantation, with >98% of the matcrial being absorbed by 12 months. The timeframe for full absorption in humans has not been determined, but is expected to be at least 12 months.
7. Warnings and Precautions
NovaBone Putty is not indicated for usc in load-bearing applications. It should not be used for vertebroplasty or kyphoplasty procedures. NovaBone Putty is intended for use by clinicians familiar with bone grafting and internal/external fixation techniques. 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 must not be used to gain screw purchase or to stabilize screw placement.
NovaBone Putty is intended for manual application and is not intended for injection. Injection of NovaBone Putty should not be conducted as it could result in device over-pressurization, which may lead to device extrusion beyond the intended application site or to embolization of fat or the device into the bloodstream.
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510(k) Premarket Notification NovaBone Products, LLC NovaBone Putty – Bioactive Synthetic Graft
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, decp 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 arisc from anesthesia and / or surgery.
9. Conclusion
NovaBone Putty is claimed to be substantially equivalent to the NovaBone Putty and NovaBone (particulate) predicate devices as a non-structural osteoconductive bone void filler for osseous defects. In vivo performance data were presented in support of the requested expansion of device claims.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 6 2008
NovaBone Products, LLC % Mr. David M. Gaisser 13709 Progress Boulevard, #33 Alachua, FL 32615
Re: K080009
Trade/Device Name: NovaBone Putty-Bioactive Synthetic Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: December 31, 2007 Received: February 27, 2008
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mullean
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 - 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 extremitics, spine 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.
NovaBone Putty is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength to support load-bearing defects prior to hard tissue ingrowth. It should not be used for vertebroplasty or kyphoplasty procedures. 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. NoyaBone Putty must not be used to gain screw purchase or to stabilize screw placement.
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)
Neil Kl. Olsen
Division of General, Restorative, and Neurological Devices
510(k) Number K040009