(27 days)
Vitoss Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Vitoss Bone Graft Substitute Filled Canister is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. The Canister provides the surgeon with a convenient way to mix autologous blood or bone marrow with Vitoss Bone Graft Substitute and deliver the material to the orthopaedic surgical site.
Vitoss Foam Bone Graft Substitute is intended for use as a bone void filler for yoids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Foam Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Vitoss Bioactive Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Vitoss Bioactive Foam Bone Graft Substitutes are resorbable, osteoconductive implants with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.
Vitoss Foam Bone Graft Substitute is a porous calcium phosphate resorbable material combined with Type I bovine collagen for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameters in the scaffold range from 1 µm to 1000 µm (1 mm). All implants are provided sterile. Vitoss Foam Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Foam Bone Graft Substitute is placed in direct contact with viable host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.
Vitoss Bone Graft Substitute Filled Canister is a device that combines two Orthovita products, Vitoss Bone Graft Substitute and the Imbibe II Syringe into a kit configuration. The convenience kit provides the Imbibe II Syringe loaded (filled) with Vitoss Bone Graft Substitute and an empty 30cc secondary syringe (Merit Piston Syringe). An adapter valve, which can be connected to the vacuum line in the surgical suite, is also provided. The surgeon can use either the secondary syringe or the vacuum line adapter to aspirate blood or marrow into the Vitoss Filled Canister.
Vitoss Bone Graft Substitute is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameters in the scaffold range from 1 um to 1000 um (1 mm). The implant is provided sterile in block and morsel forms. Vitoss Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Bone Graft Substitute is placed in direct contact with viable hose bone, new bone grows in apposition to the calcium phosphate surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.
The provided text describes several bone graft substitute products by Orthovita, Inc. and their 510(k) summary for substantial equivalence. However, it does not contain specific acceptance criteria, a detailed study protocol, or performance metrics in the way one would describe a diagnostic device's accuracy or clinical trial outcomes with statistical endpoints.
Instead, the submission focuses on establishing substantial equivalence to previously cleared predicate devices. The "Performance Data" sections highlight that physical and in-vitro testing was conducted to ensure the devices met predetermined design specifications and functioned as intended, and pre-clinical animal data demonstrates bone growth support. There is no mention of a human clinical study with specific acceptance criteria.
Therefore, many of the requested details cannot be extracted directly from the provided text.
Here is what can be inferred and explicitly stated:
-
Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the typical format of a diagnostic device's performance study (e.g., sensitivity, specificity, AUC). Instead, the performance claims are more general, stating that the products "met predetermined design specifications" and demonstrated "osteostimulatory" properties in vitro or supported "bone growth" in pre-clinical animal models.
Acceptance Criterion (Inferred) Reported Device Performance Device meets predetermined design specifications (for Vitoss Bioactive Foam Bone Graft Substitute, Vitoss Foam Bone Graft Substitute, Vitoss Bone Graft Substitute Filled Canister) "In all instances, Vitoss Bioactive Foam Bone Graft Substitutes functioned as intended." (K083033 - Vitoss Bioactive Foam) "Performance testing was conducted to ensure that Vitoss Bioactive Bone Graft Substitutes met the predetermined design specifications. In all instances, Vitoss Bioactive Foam Bone Graft Substitutes functioned as intended." (K083033 - Vitoss Bioactive Foam) Osteostimulatory properties (for Vitoss Bioactive Foam Bone Graft Substitute) "Vitoss Bioactive Foam Bone Graft Substitutes are osteostimulatory based on in-vitro studies in which calcium phosphate growth was induced on the surface of the Vitoss Bioactive Foam after exposure to simulated body fluid. This phenomenon was not observed in control samples in which there was no bioactive glass component." (K083033 - Vitoss Bioactive Foam) Support bone growth and resorption (for Vitoss Foam Bone Graft Substitute, Vitoss Bone Graft Substitute) "Pre-clinical animal data demonstrate that Vitoss Foam Bone Graft Substitute supports bone growth into a metaphyseal defect. These data show that Vitoss Foam Bone Graft Substitute is resorbed concurrently with bone ingrowth and remodeling." (K083033 - Vitoss Foam) "Results from animal studies demonstrate that eighty percent of Vitoss Bone Graft Substitute is resorbed within twelve weeks." (K083033 - Vitoss Bone Graft Substitute) Biocompatibility and safety "Previous testing (e.g., pre-clinical animal, biocompatibility, and in-vitro) have demonstrated that Vitoss Bone Graft Substitute is safe and effective for its intended use." (K083033 - Vitoss Bone Graft Substitute and Vitoss Bone Graft Substitute Filled Canister) "These results, in conjunction with in-vitro data, demonstrate that Vitoss Foam Bone Graft Substitute is as safe and as effective as the predicate devices." (K083033 - Vitoss Foam) -
Sample size used for the test set and the data provenance:
- Test set sample size: Not specified.
- Data provenance:
- Vitoss Bioactive Foam Bone Graft Substitute: In-vitro studies (simulated body fluid exposure). "The osteostimulatory nature of Vitoss Bioactive Foam Bone Graft Substitute has not been correlated to human clinical experience."
- Vitoss Foam Bone Graft Substitute: Pre-clinical animal data.
- Vitoss Bone Graft Substitute / Vitoss Bone Graft Substitute Filled Canister: Previous testing (e.g., pre-clinical animal, biocompatibility, and in-vitro). The specific new test set (if any beyond the "predetermined design specifications" checks) and its provenance are not detailed.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. The studies mentioned are primarily in-vitro and animal studies, not human expert evaluations for ground truth.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI diagnostic tool and therefore does not involve human readers for interpretation in this context.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (bone graft substitute), not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Vitoss Bioactive Foam Bone Graft Substitute: Calcium phosphate growth in simulated body fluid (in-vitro).
- Vitoss Foam Bone Graft Substitute / Vitoss Bone Graft Substitute: Bone growth and resorption in pre-clinical animal models.
-
The sample size for the training set: Not applicable/not provided. This is a medical device, not a machine learning model requiring a "training set." The materials and manufacturing processes are likely developed and optimized through iterative testing, but this is not referred to as a "training set."
-
How the ground truth for the training set was established: Not applicable for this type of device.
{0}------------------------------------------------
Orthovita, Inc. Vitoss Bioactive Foam Bone Graft Substitute Special 510(k)
510(k) Summary Vitoss Bioactive Foam Bone Graft Substitute
510(k) Number (if known): K083033
NOV - 6 2008
| Sponsor: | Orthovita, Inc.45 Great Valley ParkwayMalvern, PA 19355 USA(t) 610-640-1775 - (f) 610-640-1714 |
|---|---|
| Company Representative: | Deborah L. Jackson, RACRegulatory Affairs Specialist(email) djackson@orthovita.com |
| Date Prepared: | November 4, 2008 |
| Device Trade Name: | Vitoss Bioactive Foam Bone Graft Substitute |
| Common or Usual Name: | Bone Void Filler |
| Regulation Number: | 888.3045 |
| Regulation Name: | Resorbable calcium salt bone void filler device |
| Regulatory Class: | Class II |
| Product Code: | MQV |
| Predicate Devices: | Vitoss Bioactive Foam Bone Graft Substitute - K072184Vitoss Bioactive Foam Bone Graft Substitute - STRIP andPACK - K081439 |
| Device Description: | Vitoss Bioactive Foam Bone Graft Substitutes are resorbable,osteoconductive implants with a trabecular structure thatresembles the multidirectional interconnected porosity ofhuman cancellous bone |
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Orthovita, Inc. Foam Bone Graft Substitute Special 510(k)
| Intended Use: | Vitoss Bioactive Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. |
|---|---|
| Vitoss Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with salinc, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process. | |
| Performance Data: | Performance testing was conducted to ensure that Vitoss Bioactive Bone Graft Substitutes met the predetermined design specifications. In all instances, Vitoss Bioactive Foam Bone Graft Substitutes functioned as intended. |
| Vitoss Bioactive Foam Bone Graft Substitutes are osteostimulatory based on in-vitro studies in which calcium phosphate growth was induced on the surface of the Vitoss Bioactive Foam after exposure to simulated body fluid. This phenomenon was not observed in control samples in which there was no bioactive glass component. The osteostimulatory nature of Vitoss Bioactive Foam Bone Graft Substitute has not been correlated to human clinical experience. | |
| Substantial Equivalence: | Information within this submission supports substantial equivalence. |
:
{2}------------------------------------------------
Orthovita, Inc. Vitoss Foam Bone Graft Substitute Special 510(k)
510(k) Summary Vitoss Foam Bone Graft Substitute
510(k) Number (if known): K083033
| Sponsor: | Orthovita, Inc.45 Great Valley ParkwayMalvern, PA 19355 USA(t) 610-640-1775 – (f) 610-640-1714 |
|---|---|
| Company Representative: | Deborah L. Jackson, RACRegulatory Affairs Specialist(email) djackson@orthovita.com |
| Date Prepared: | November 4, 2008 |
| Device Trade Name: | Vitoss Foam Bone Graft Substitute |
| Common or Usual Name: | Bone Void Filler |
| Regulation Number: | 888.3045 |
| Regulation Name: | Resorbable calcium salt bone void filler device |
| Regulatory Class: | Class II |
| Product Code: | MQV |
| Predicate Devices: | Vitoss Scaffold Foam Bone Graft Material – K032288 |
| Device Description: | Vitoss Foam Bone Graft Substitute is a porous calcium phosphateresorbable material combined with Type I bovine collagen for therepair of bony defects. It is an osteoconductive porous implantwith a trabecular structure that resembles the multidirectionalinterconnected porosity of human cancellous bone. Porediameters in the scaffold range from 1 µm to 1000 µm (1 mm).All implants are provided sterile.Vitoss Foam Bone Graft Substitute guides the three-dimensionalregeneration of bone in the defect site into which it is implanted.When Vitoss Foam Bone Graft Substitute is placed in directcontact with viable host bone, new bone grows in apposition tothe surfaces of the implant. As the implant resorbs, bone andother connective tissues grow into the space previously occupiedby the scaffold. |
{3}------------------------------------------------
| Intended Use: | Vitoss Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Foam Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process. |
|---|---|
| Performance Data: | Pre-clinical animal data demonstrate that Vitoss Foam Bone Graft Substitute supports bone growth into a metaphyseal defect. These data show that Vitoss Foam Bone Graft Substitute is resorbed concurrently with bone ingrowth and remodeling. These results, in conjunction with in-vitro data, demonstrate that Vitoss Foam Bone Graft Substitute is as safe and as effective as the predicate devices. |
| Substantial Equivalence: | Information within this submission supports substantial equivalence. |
{4}------------------------------------------------
510(k) Summary Vitoss Bone Graft Substitute Filled Canister
:
510(k) Number (if known): K083033
:
| Sponsor: | Orthovita, Inc.45 Great Valley ParkwayMalvern, PA 19355 USA(t) 610-640-1775 - (f) 610-640-1714 |
|---|---|
| Company Representative: | Deborah L. Jackson, RACRegulatory Affairs Specialist(email) djackson@orthovita.com |
| Date Prepared: | November 4, 2008 |
| Device Trade Name: | Vitoss Bone Graft Substitute Filled Canister |
| Common or Usual Name: | Bone Void Filler |
| Regulation Number: | 888.3045 |
| Regulation Name: | Resorbable calcium salt bone void filler device |
| Regulatory Class: | Class II |
| Product Code: | MQV |
| Predicate Devices: | Vitoss Filled Cartridge - K032130 |
| Device Description: | Vitoss Bone Graft Substitute Filled Canister is a device thatcombines two Orthovita products, Vitoss Bone Graft Substitute andthe Imbibe II Syringe into a kit configuration. The convenience kitprovides the Imbibe II Syringe loaded (filled) with Vitoss BoneGraft Substitute and an empty 30cc secondary syringe (MeritPiston Syringe). An adapter valve, which can be connected to thevacuum line in the surgical suite, is also provided. The surgeoncan use either the secondary syringe or the vacuum line adapter toaspirate blood or marrow into the Vitoss Filled Canister. |
{5}------------------------------------------------
| Intended Use: | Vitoss Bone Graft Substitute is intended for use as a bone voidfiller for voids or gaps that are not intrinsic to the stability of thebony structure. Vitoss Bone Graft Substitute is indicated for use inthe treatment of surgically created osseous defects or osscousdefects created from traumatic injury to the bone. |
|---|---|
| Vitoss Bone Graft Substitute is intended to be used for filling bonyvoids or gaps of the skeletal system (i.e., the extremities, pelvis andspine, which includes posterolateral fusion procedures), and maybe combined with saline, autogenous blood, and/or bone marrow.Following placement in the bony void or gap, the scaffold resorbsand is replaced with bone during the healing process. | |
| Vitoss Bone Graft Substitute Filled Canister is intended for use as apiston syringe system for the aspiration of autogenous blood and/orbone marrow. The Canister provides the surgeon with a convenientway to mix autologous blood or bone marrow with Vitoss BoneGraft Substitute and deliver the material to the orthopaedic surgicalsite. | |
| Performance Data: | Previous testing (e.g., pre-clinical animal, biocompatibility, and in-vitro) have demonstrated that Vitoss Bone Graft Substitute is safeand effective for its intended use. |
| Substantial Equivalence: | Information within this submission supports substantialequivalence. |
{6}------------------------------------------------
510(k) Summary Vitoss Bone Graft Substitute
510(k) Number (if known): K083033
| Sponsor: | Orthovita, Inc.45 Great Valley ParkwayMalvern, PA 19355 USA(t) 610-640-1775 - (f) 610-640-1714 |
|---|---|
| Company Representative: | Deborah L. Jackson, RACRegulatory Affairs Specialist(email) djackson@orthovita.com |
| Date Prepared: | November 4, 2008 |
| Device Trade Name: | Vitoss Bone Graft Substitute |
| Common or Usual Name: | Bone Void Filler |
| Regulation Number: | 888.3045 |
| Regulation Name: | Resorbable calcium salt bone void filler device |
| Regulatory Class: | Class II |
| Product Code: | MQV |
| Predicate Devices: | Vitoss Scaffold Synthetic Cancellous Bone Void Filler - K032409and K994337 |
| Device Description: | Vitoss Bone Graft Substitute is a porous calcium phosphate resorbablebone void filler for the repair of bony defects. It is an osteoconductiveporous implant with a trabecular structure that resembles themultidirectional interconnected porosity of human cancellous bone.Pore diameters in the scaffold range from 1 um to 1000 um (1 mm).The implant is provided sterile in block and morsel forms. |
| Vitoss Bone Graft Substitute guides the three-dimensional regenerationof bone in the defect site into which it is implanted. When Vitoss BoneGraft Substitute is placed in direct contact with viable hose bone, newbone grows in apposition to the calcium phosphate surfaces of theimplant. As the implant resorbs, bone and other connective tissues growinto the space previously occupied by the scaffold. Results from animalstudies demonstrate that eighty percent of Vitoss Bone Graft Substituteis resorbed within twelve weeks. |
{7}------------------------------------------------
Orthovita, Inc. Vitoss Bone Graft Substitute Special 510(k)
Vitoss Bone Graft Substitute is intended for use as a bone void filler Intended Use: for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process. Previous testing (e.g., pre-clinical animal, biocompatibility, and in-Performance Data: vitro) have demonstrated that Vitoss Bone Graft Substitute is safe and effective for its intended use. Information within this submission supports substantial equivalence. Substantial Equivalence:
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Orthovita, Inc. % Ms. Deborah L. Jackson, RAC Regulatory Affairs Specialist 45 Great Valley Parkway Malvern, Pennsylvania 19355
NOV - 6 2008
Re: K083033
Trade/Device Name: Vitoss Bone Graft Substitute, Vitoss Bonc Graft Substitute Filled Canister, Vitoss Foam Bone Graft Substitute, Vitoss Bioactive Foam Bone Graft Substitute
Regulation Number: 21 CFR 888.3045
Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: October 10, 2008 Received: October 10, 2008
Dear Ms. Jackson:
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
{9}------------------------------------------------
Page 2 - Ms. Deborah L. Jackson, RAC
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 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 the reporting 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 e 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 H Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{10}------------------------------------------------
Orthovita, Inc. Vitoss Bone Graft Substitute Special 510(k)
Indications for Use Statement
510(k) Number (if known): K083033
Device Name:
Vitoss Bonc Graft Substitute
Indications for Use:
Vitoss Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Vitoss Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The Counter Use X (21 CFR 807 Subpart C)
X3033
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Melkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
{11}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): K083033
Device Name:
Vitoss Bone Graft Substitute Filled Canister
Indications for Use:
Vitoss Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Vitoss Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Vitoss Bone Graft Substitute Filled Canister is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. The Canister provides the surgeon with a convenient way to mix autologous blood or bone marrow with Vitoss Bone Graft Substitute and deliver the material to the orthopaedic surgical site.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The Counter Use X (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) | |
|---|---|
| Mark N Milliren |
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
{12}------------------------------------------------
Orthovita, Inc. Vitoss Foam Bone Graft Substitute Special 510(k)
Indications for Use Statement
510(k) Number (if known): K083033
Device Name:
Vitoss Foam Bone Graft Substitute
Indications for Use:
Vitoss Foam Bone Graft Substitute is intended for use as a bone void filler for yoids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Foam Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Vitoss Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Prescription Use (Part 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)
X
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milken
Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K083033
{13}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): K083033
Device Name:
Vitoss Bioactive Foam Bone Graft Substitute
Indications for Use:
Vitoss Bioactive Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Vitoss Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Prescription Use (Part 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)
X
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
l of 1
510(k) Number
§ 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.