VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE

K083033 · Orthovita, Inc. · MQV · Nov 6, 2008 · Orthopedic

Device Facts

• Record ID: K083033
• Device Name: VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
• Applicant: Orthovita, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Nov 6, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2

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.

Device Story

Resorbable, osteoconductive bone void filler; trabecular structure mimics human cancellous bone; porous calcium phosphate scaffold (pore sizes 1-1000 µm). Used in orthopedic surgery to fill skeletal voids/gaps; may be combined with saline, autogenous blood, or bone marrow. Implant guides 3D bone regeneration; resorbs over time as host bone grows into scaffold. Filled Canister configuration includes Imbibe II syringe and vacuum adapter for aspiration/mixing of autologous blood/marrow. Surgeon-operated in clinical setting; provides scaffold for bone healing.

Clinical Evidence

No clinical data. Evidence consists of pre-clinical animal studies demonstrating bone ingrowth and resorption, in-vitro studies confirming osteostimulatory properties (calcium phosphate growth in simulated body fluid), and biocompatibility testing.

Technological Characteristics

Porous calcium phosphate scaffold; trabecular structure; pore diameters 1-1000 µm. Some variants include Type I bovine collagen. Provided sterile. Mechanical/physical bone void filler; no active energy source or software.

Indications for Use

Indicated for patients with surgically created osseous defects or traumatic bone injuries requiring bone void filling in the skeletal system, including extremities, pelvis, and spine (posterolateral fusion). Not for use in defects intrinsic to bony stability.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Vitoss Bioactive Foam Bone Graft Substitute (K072184)
• Vitoss Bioactive Foam Bone Graft Substitute - STRIP and PACK (K081439)
• Vitoss Scaffold Foam Bone Graft Material (K032288)
• Vitoss Filled Cartridge (K032130)
• Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K032409)
• Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K994337)

Submission Summary (Full Text)

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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.<br>45 Great Valley Parkway<br>Malvern, PA 19355 USA<br>(t) 610-640-1775 - (f) 610-640-1714 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Representative: | Deborah L. Jackson, RAC<br>Regulatory Affairs Specialist<br>(email) [e-mail] |
| 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 - K072184<br>Vitoss Bioactive Foam Bone Graft Substitute - STRIP and<br>PACK - K081439 |
| Device Description: | Vitoss Bioactive Foam Bone Graft Substitutes are resorbable,<br>osteoconductive implants with a trabecular structure that<br>resembles the multidirectional interconnected porosity of<br>human 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. |

:

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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.<br>45 Great Valley Parkway<br>Malvern, PA 19355 USA<br>(t) 610-640-1775 – (f) 610-640-1714 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Representative: | Deborah L. Jackson, RAC<br>Regulatory Affairs Specialist<br>(email) [e-mail] |
| 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 phosphate<br>resorbable material combined with Type I bovine collagen for the<br>repair of bony defects. It is an osteoconductive porous implant<br>with a trabecular structure that resembles the multidirectional<br>interconnected porosity of human cancellous bone. Pore<br>diameters in the scaffold range from 1 µm to 1000 µm (1 mm).<br>All implants are provided sterile.<br><br>Vitoss Foam Bone Graft Substitute guides the three-dimensional<br>regeneration of bone in the defect site into which it is implanted.<br>When Vitoss Foam Bone Graft Substitute is placed in direct<br>contact with viable host bone, new bone grows in apposition to<br>the surfaces of the implant. As the implant resorbs, bone and<br>other connective tissues grow into the space previously occupied<br>by the scaffold. |

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| 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. |

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# 510(k) Summary Vitoss Bone Graft Substitute Filled Canister

:

# 510(k) Number (if known): K083033

:

| Sponsor: | Orthovita, Inc.<br>45 Great Valley Parkway<br>Malvern, PA 19355 USA<br>(t) 610-640-1775 - (f) 610-640-1714 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Representative: | Deborah L. Jackson, RAC<br>Regulatory Affairs Specialist<br>(email) [e-mail] |
| 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 that<br>combines two Orthovita products, Vitoss Bone Graft Substitute and<br>the Imbibe II Syringe into a kit configuration. The convenience kit<br>provides the Imbibe II Syringe loaded (filled) with Vitoss Bone<br>Graft Substitute and an empty 30cc secondary syringe (Merit<br>Piston Syringe). An adapter valve, which can be connected to the<br>vacuum line in the surgical suite, is also provided. The surgeon<br>can use either the secondary syringe or the vacuum line adapter to<br>aspirate blood or marrow into the Vitoss Filled Canister. |

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| Intended Use: | Vitoss Bone Graft Substitute is intended for use as a bone void<br>filler for voids or gaps that are not intrinsic to the stability of the<br>bony structure. Vitoss Bone Graft Substitute is indicated for use in<br>the treatment of surgically created osseous defects or osscous<br>defects created from traumatic injury to the bone. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Vitoss Bone Graft Substitute is intended to be used for filling bony<br>voids or gaps of the skeletal system (i.e., the extremities, pelvis and<br>spine, which includes posterolateral fusion procedures), and may<br>be combined with saline, autogenous blood, and/or bone marrow.<br>Following placement in the bony void or gap, the scaffold resorbs<br>and is replaced with bone during the healing process. |
| | Vitoss Bone Graft Substitute Filled Canister is intended for use as a<br>piston syringe system for the aspiration of autogenous blood and/or<br>bone marrow. The Canister provides the surgeon with a convenient<br>way to mix autologous blood or bone marrow with Vitoss Bone<br>Graft Substitute and deliver the material to the orthopaedic surgical<br>site. |
| Performance Data: | Previous testing (e.g., pre-clinical animal, biocompatibility, and in-<br>vitro) have demonstrated that Vitoss Bone Graft Substitute is safe<br>and effective for its intended use. |
| Substantial Equivalence: | Information within this submission supports substantial<br>equivalence. |

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## 510(k) Summary Vitoss Bone Graft Substitute

# 510(k) Number (if known): K083033

| Sponsor: | Orthovita, Inc.<br>45 Great Valley Parkway<br>Malvern, PA 19355 USA<br>(t) 610-640-1775 - (f) 610-640-1714 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Representative: | Deborah L. Jackson, RAC<br>Regulatory Affairs Specialist<br>(email) [e-mail] |
| 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 - K032409<br>and K994337 |
| Device Description: | Vitoss Bone Graft Substitute is a porous calcium phosphate resorbable<br>bone void filler for the repair of bony defects. It is an osteoconductive<br>porous implant with a trabecular structure that resembles the<br>multidirectional interconnected porosity of human cancellous bone.<br>Pore diameters in the scaffold range from 1 um to 1000 um (1 mm).<br>The implant is provided sterile in block and morsel forms. |
| | Vitoss Bone Graft Substitute guides the three-dimensional regeneration<br>of bone in the defect site into which it is implanted. When Vitoss Bone<br>Graft Substitute is placed in direct contact with viable hose bone, new<br>bone grows in apposition to the calcium phosphate surfaces of the<br>implant. As the implant resorbs, bone and other connective tissues grow<br>into the space previously occupied by the scaffold. Results from animal<br>studies demonstrate that eighty percent of Vitoss Bone Graft Substitute<br>is resorbed within twelve weeks. |

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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:

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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

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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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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

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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

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### 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) | |
|-------------------------------------------------------|-------------------------------------------------------|
| | <div style="text-align:center;">Mark N Milliren</div> |

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

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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

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### 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