Vitoss Bioactive (BA) Injectable

K163621 · Orthovita, Inc. · MQV · May 2, 2017 · Orthopedic

Device Facts

Record IDK163621
Device NameVitoss Bioactive (BA) Injectable
ApplicantOrthovita, Inc.
Product CodeMQV · Orthopedic
Decision DateMay 2, 2017
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3045
Device ClassClass 2
AttributesTherapeutic

Intended Use

Vitoss BA Injectable 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 BA Injectable is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss BA Injectable is intended to be used for filling bony voids and gaps of the skeletal system (i.e. the extremities and pelvis), 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.

Device Story

Synthetic, resorbable, porous bone void filler; composed of beta tricalcium phosphate and bioactive glass in porcine gelatin and sodium carboxymethyl cellulose carrier. Supplied in syringe; hydrated with saline, autogenous blood, or bone marrow at point-of-care; mixed via syringe-to-syringe system. Administered by physician via injection through cannula or manual application into bony voids/gaps. Scaffold provides osteoconductive trabecular structure mimicking human cancellous bone; resorbs over time as new bone and connective tissue grow into defect site. Benefits patient by facilitating bone healing in non-structural defects.

Clinical Evidence

No clinical data. Evidence includes bench testing: comparative animal performance in rabbit model, in-vitro bioactivity (calcium phosphate growth in simulated body fluid), permeability, irrigation, usability, extrusion, packaging/shelf-life, sterilization validation, and biocompatibility.

Technological Characteristics

Synthetic resorbable porous implant; beta tricalcium phosphate and bioactive glass; porcine gelatin and sodium carboxymethyl cellulose carrier. Trabecular structure; syringe-delivered; hydrated at point-of-use. Sterilization validation performed.

Indications for Use

Indicated for treatment of surgically created or traumatic osseous defects in the skeletal system (extremities and pelvis) in patients requiring bone void filling for non-structural gaps.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, composed of three curved lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 2, 2017 Orthovita, Inc. % John Rossman Regulatory Affairs Project Manager Stryker Corporation Stryker Spine 59 Route 17 South Allendale, New Jersey 07401 Re: K163621 Trade/Device Name: Vitoss Bioactive (BA) Injectable Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: March 13, 2017 Received: March 17, 2017 Dear Mr. Rossman: 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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K163621 Device Name Vitoss Bioactive (BA) Injectable #### Indications for Use (Describe) Vitoss BA Injectable 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 BA Injectable is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss BA Injectable is intended to be used for filling bony voids and gaps of the skeletal system (i.e. the extremities and pelvis), 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------|------------------------------------------------------------------| | <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is centered and takes up most of the image. | 510(k) Summary: | Vitoss BA Injectable Bone Graft Substitute | |------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Stryker Orthobiologics<br>74 East Swedesford Road<br>Malvern, PA 19355 | | Contact Person : | Name: John Rossman<br>Phone: (201) 749-8193<br>Fax: (201) 831-3000<br>Email: john.rossman@stryker.com | | Date Prepared: | 04/24/2017 | | Trade Name: | Vitoss Bioactive (BA) Injectable | | Common Name: | Resorbable calcium salt bone void filler device | | Proposed Class: | Class II | | Classification Name: | Filler, Bone Void, Calcium Compound (21 CFR 888.3045)<br>Syringe, Piston (21 CFR 880.5860) | | Product Code: | MQV<br>FMF | | Predicate Devices: | Primary Predicate:<br>Vitoss BA Foam Pack (K081439)<br><br>Additional Predicates:<br>Vitoss BA BiModal (K103173)<br>NanOss Bioactive Loaded (K141600)<br>Carricell (K132868) | | Device Description: | Vitoss BA Injectable bone graft substitute is a synthetic resorbable porous<br>bone void filler for the repair of bony defects made from a combination of<br>beta tricalcium phosphate and bioactive glass in a carrier of porcine gelatin<br>and sodium carboxymethyl cellulose. It is an osteoconductive porous implant<br>with a trabecular structure that resembles the multidirectional<br>interconnected porosity of human cancellous bone.<br><br>Vitoss BA Injectable is provided prepackaged in a syringe. At the time of use a<br>specified volume of hydration fluid is combined with the dry component of<br>the device. Mixing is facilitated by a syringe to syringe mixing system. The<br>resulting material can be administered to the treatment site by injection<br>through a cannula or by manual application. After injection or insertion into<br>the defect site new bone grows in apposition to the surfaces of the implant. As<br>the implant resorbs, bone and other connective tissues grow into the space<br>previously occupied by the scaffold. | | 510(k) Summary: Vitoss BA Injectable Bone Graft Substitute | | | Intended Use: | Vitoss BA Injectable is intended for use as a bone void filler for voids or gaps<br>that are not intrinsic to the stability of the bony structure. Vitoss BA<br>Injectable is indicated for use in the treatment of surgically created osseous<br>defects or osseous defects created from traumatic injury to the bone.<br><br>Vitoss BA Injectable is intended to be used for filling bony voids and gaps of<br>the skeletal system (i.e. the extremities and pelvis), and may be combined<br>with saline, autogenous blood, and/or bone marrow. Following placement in<br>the bony void or gap, the scaffold resorbs and is replaced with bone during<br>the healing process. | | Summary of the<br>Technological<br>Characteristics | Vitoss BA Injectable was shown to be substantially equivalent and has<br>equivalent technological characteristics to its predicate devices through<br>comparison in areas including intended use, material composition,<br>principles of operation and design. | | Summary of the<br>Performance Data | Risk analysis was performed to demonstrate that Vitoss BA Injectable is<br>substantially equivalent to its predicate devices. The risk analysis<br>determined that the predefined acceptance criteria was met for the following:<br>• Comparative animal performance testing in a rabbit model<br>• Bioactivity testing included in-vitro studies in which calcium phosphate<br>growth was induced on the surface of Vitoss Bioactive Injectable in the<br>presence of simulated body fluid. This phenomenon was not observed in<br>control samples in which there was no bioactive glass component. The<br>bioactivity has not been evaluated in human clinical trials.<br>• Permeability testing<br>• Irrigation testing<br>• Usability testing<br>• Extrusion testing<br>• Packaging and shelf life validations<br>• Sterilization validation<br>• Biocompatibility | | Conclusion | The proposed Vitoss BA Injectable has equivalent indications, technological<br>characteristics, and principles of operation as its predicates. The risk<br>analysis performed demonstrates that any minor differences do not impact<br>device performance as compared to the predicates. The design verifications<br>and validations performed as a result of the risk analysis and presented in the<br>submission demonstrate the proposed device does not raise new questions of<br>safety or effectiveness. Thus, the aforementioned predicate devices and<br>subject device are considered substantially equivalent. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all in lowercase and are black. The word is centered in the image and takes up most of the space.
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