Vitoss BiModal Bone Graft Substitute Foam Strip

K153608 · Orthovita, Inc. · MQV · Feb 12, 2016 · Orthopedic

Device Facts

• Record ID: K153608
• Device Name: Vitoss BiModal Bone Graft Substitute Foam Strip
• Applicant: Orthovita, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Feb 12, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip 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 BiModal Foam Strip is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss BiModal Foam Strip is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine) 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 process.

Device Story

Resorbable, porous, osteoconductive bone void filler; trabecular structure mimics human cancellous bone; pore diameters 1-1000 um. Implanted by surgeons into bony voids/gaps; may be combined with saline, autogenous blood, or bone marrow. Scaffold guides 3D bone regeneration; new bone grows in apposition to implant surfaces; scaffold resorbs and is replaced by bone/connective tissue during healing. Used in clinical settings for orthopedic procedures.

Clinical Evidence

Bench testing only. Risk analysis and verification/validation performed, including wettability, fluid retention, porosity, bioactivity, clinical handling, shelf-life stability, and biocompatibility.

Technological Characteristics

Resorbable porous bone void filler; trabecular structure; pore diameters 1-1000 um. Osteoconductive material. No specific ASTM standards cited in provided text.

Indications for Use

Indicated for patients requiring treatment of surgically created or traumatic osseous defects in the skeletal system, including extremities, pelvis, and posterolateral spine, where the void is not 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 BA Foam Strip (K072184)
• Vitoss BiModal Foam Pack (K103173)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 12, 2016

Orthovita, Incorporated Ms. Meriam Gabera Senior Regulatory Affairs Specialist 59 Route 17 South Allendale, New Jersey 07401

Re: K153608

Trade/Device Name: Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: January 21, 2016 Received: January 22, 2016

Dear Ms. Gabera:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K153608

Device Name

Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip

Indications for Use (Describe)

Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip 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 BiModal Foam Strip is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Vitoss BiModal Foam Strip is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine) 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 process.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

| 510(k) Summary: Vitoss BiModal Foam Strip | |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Stryker Orthobiologics |
| | 74 East Swedesford Road |
| | Malvern, PA 19355 |
| Contact Person | Meriam Gabera |
| | Senior Regulatory Affairs Specialist |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date Prepared | December 16, 2015 |
| Trade Name | Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip |
| Common Name | Resorbable calcium salt bone void filler device |
| Proposed Class | Class II |
| Classification Name<br>and Number | Filler, Bone Void, Calcium Compound |
| | 888.3045 |
| Product Code | MQV |
| Predicate Devices | Primary Predicate<br>Secondary Predicate |
| | Vitoss BA Foam Strip (K072184)<br>Vitoss BiModal Foam Pack (K103173) |
| Device Description | Vitoss BiModal Foam Strip is a resorbable porous bone void filler for the<br>repair of bony defects. It is an osteoconductive, porous implant with a<br>trabecular structure that resembles the multidirectional interconnected<br>porosity of human cancellous bone. Pore diameters in the scaffold range<br>from 1 to 1000 um. |
| | Vitoss BiModal Foam Strip guides the three-dimensional regeneration of<br>bone in the defect site into which it is implanted. When Vitoss BiModal<br>Foam Strip is placed in direct contact with host bone, new bone grows in<br>apposition to the surfaces of the implant. As the implant resorbs, bone and<br>other connective tissues grow into the space previously occupied by the<br>scaffold. |
| Intended Use | Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip is intended for<br>use as a bone void filler for voids or gaps that are not intrinsic to the<br>stability of the bony structure. Vitoss BiModal Foam Strip is indicated for<br>use in the treatment of surgically created osseous defects or osseous defects<br>created from traumatic injury to the bone. |
| 510(k) Summary: Vitoss BiModal Foam Strip | |
| | Vitoss BiModal Foam Strip is intended to be used for filling bony voids or<br>gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral<br>spine) and may be combined with saline, autogenous blood, and/or bone<br>marrow. Following placement in the bony void or gap, the scaffold resorbs<br>and is replaced with bone during the healing process. |
| Summary of the<br>Technological<br>Characteristics | As established in this submission, Vitoss BiModal Foam Strip was shown<br>to be substantially equivalent and has equivalent technological<br>characteristics to its predicate device through comparison in areas<br>including intended use, material composition, principles of operation and<br>design. |
| Summary of the<br>Performance Data | Risk analysis was performed to demonstrate that Vitoss BiModal Foam<br>Strip is substantially equivalent to its predicate devices. The risk analysis<br>determined that the predefined acceptance criteria was met for the<br>following:<br>• Wettability and Fluid Retention Verification<br>• Porosity Verification<br>• Bioactivity Verification<br>• Clinical Handling Verification<br>• Product Stability throughout shelf-life<br>• Biocompatibility<br>• Design Validation |
| Conclusion | The proposed Vitoss BiModal Foam Strip has identical indications,<br>technological characteristics, and principles of operation as its predicates.<br>The risk analysis performed demonstrates that any minor differences do not<br>impact device performance as compared to the predicates. The design<br>verifications and validations performed as a result of the risk analysis and<br>presented herein demonstrate the proposed device does not raise new<br>questions of safety or effectiveness. Thus, the predicate devices (K072184<br>and K103173) and proposed device are considered substantially equivalent. |

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## K153608

### Vitoss BiModal Foam Strip