FIBERGRAFT BG Matrix Bone Graft Substitute

K171284 · Prosidyan, Inc. · MQV · Jun 30, 2017 · Orthopedic

Device Facts

• Record ID: K171284
• Device Name: FIBERGRAFT BG Matrix Bone Graft Substitute
• Applicant: Prosidyan, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Jun 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2

Intended Use

FIBERGRAFT® BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). 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. FIBERGRAFT® BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

Device Story

FIBERGRAFT® BG Matrix is a resorbable, osteoconductive bone void filler. Composition includes 45S5 bioactive glass (M-45 granules, MS-45 microspheres) and bovine type I collagen. Device is hydrated with autogenous bone marrow aspirate (BMA) and mixed with autograft in a 1:1 ratio before implantation. Intended for surgical use by physicians to fill non-structural bony voids or gaps in the skeletal system, including the posterolateral spine. Collagen component provides a single-piece form factor for ease of handling during surgery. Device resorbs over time and is replaced by host bone during the healing process. Benefits include providing a scaffold for bone growth in osseous defects.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (physical/chemical properties, biocompatibility per ISO 10993, endotoxin testing) and a prospective animal study. Rabbit study (n=53) evaluated performance in critical-sized cancellous bone defects in the posterolateral spine over 26 weeks. Endpoints included radiographic, histological, histomorphometric, and biomechanical assessments. Results demonstrated substantial equivalence to the predicate and positive control.

Technological Characteristics

Bioactive, osteoconductive, resorbable bone graft substitute. Materials: 45S5 bioactive glass (M-45 granules, MS-45 microspheres) and bovine type I collagen. Form factor: single-piece matrix. Energy source: none. Connectivity: none. Sterilization: not specified. Software: none.

Indications for Use

Indicated for bony voids or gaps not intrinsic to skeletal stability in the skeletal system, specifically the posterolateral spine. Applicable to surgically created osseous defects or traumatic bone injuries. Must be used with autogenous bone marrow aspirate and autograft.

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

• Stryker/Orthovita Inc, Vitoss Bioactive Bimodal (K103173)

Reference Devices

• NovaBone Products LLC, Novabone MacroFORM (K140946)
• FIBERGRAFT BG Morsels (K141956, K132805, K151154)
• FIBERGRAFT BG Putty (K143533)

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

June 30, 2017

Prosidyan, Inc. % Ms. Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K171284

Trade/Device Name: FIBERGRAFT® BG Matrix Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: May 1, 2017 Received: May 1, 2017

Dear Ms. Hogan:

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

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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 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/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 [phone] or [phone] 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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K171284

Device Name

FIBERGRAFT® BG Matrix Bone Graft Substitute

Indications for Use (Describe)

FIBERGRAFT® BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). 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. FIBERGRAFT® BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)

□ Over-The-Counter Use (21 CFR 801

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

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# 510(k) SUMMARY

# Prosidyan, Inc.'s FIBERGRAFT® BG Matrix - Bone Graft Substitute

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Prosidvan. Inc. 30 Technology Drive Warren. NJ 07059 Phone: [phone] Facsimile: [phone] Contact Person: Charanpreet S. Bagga

Date Prepared: June 29, 2017

#### Name of Device and Name

FIBERGRAFT® BG Matrix Bone Graft Substitute

Common or Usual Name Bone Void Filler

#### Classification Name/CFR Requlation/Product Code

Resorbable Calcium Salt Bone Void Filler, 21 CFR 888.3045, product code MQV

#### Predicate Device

- Stryker/Orthovita Inc, Vitoss Bioactive Bimodal (K103173) .
# Reference Device

- NovaBone Products LLC, Novabone MacroFORM (K140946) ●
# Intended Use / Indications for Use

FIBERGRAFT® BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). 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. FIBERGRAFT® BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

# Device Description

FIBERGRAFT® BG Matrix product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. The product is intended to be hydrated with BMA and mixed with autograft in a 1:1 ratio.

# Technological Characteristics

BG Matrix is a bioactive osteoconductive, resorbable, biocompatible bone graft substitute. The product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. After hydrating with BMA, the BG Matrix must be mixed with autograft.

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The same M-45 granules have previously been 510(k) cleared in Prosidyan's FIBERGRAFT BG Morsels (K141956, K132805, and K151154) and FIBERGRAFT BG Putty (K143533). The MS-45 microspheres included in the proposed device have also been cleared in the company's FIBERGRAFT BG Puttv (K143533),

The addition of collagen creates a single piece bone graft in a shape and size that is clinically relevant for ease of use during implantation.

#### Performance Data

The performance of the FIBERGRAFT® BG Matrix has been established by undertaking physical and chemical property evaluation studies, functional performance animal studies and biocompatibility tests. The physical and chemical property studies confirmed the in vitro functionality and bioactivity of the BG Matrix. The in vitro bioactivity test results have not been correlated to clinical performance. The biocompatibility of the FIBERGRAFT® BG Matrix is demonstrated by ISO 10993 testing and the long history of clinical use of the bioactive glass material for the same intended use. In addition, the BG Matrix is composed of the same bioactive glass material and the same type and duration of patient contact as the predicates. Packaging evaluations, shelf life testing and real time aging testing were performed with passing results. Bacterial endotoxin testing was performed using the limulus amebocyte lysate (LAL) method and showed that the device meets the endotoxin limits of established quidelines.

The FIBERGRAFT® BG Matrix product was evaluated in a rabbit study to further support device performance for its indications for use. The FIBERGRAFT® BG Matrix product was compared to its predicate device as well as controls. The animal study evaluated device performance in critical sized cancellous bone in the posterolateral spine of 53 skeletally mature rabbits. The performance was evaluated using radiographic, histological, histomorphometric, and biomechanical data. Testing of the FIBERGRAFT® BG Matrix in the rabbit model is representative of the indications for use and range of anatomical sites proposed for the subject device. The results of the study through 26 week follow up demonstrated that the FIBERGRAFT® BG Matrix device performs substantially equivalently to the predicate device and positive control, and any minor technological differences between the device groups do not raise new types of safety or effectiveness concerns.

Therefore, performance testing demonstrated that the FIBERGRAFT® BG Matrix device functions as intended and meets the requirements of class II bone void fillers as compared to the predicate device.

# Substantial Equivalence

As demonstrated in performance testing, the FIBERGRAFT® BG Matrix has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate and reference devices. The minor technological differences between BG Matrix and its predicate device do not raise any new issues of safety or effectiveness. The data demonstrate that BG Matrix is substantially equivalent to the predicate device.

# Conclusion

FIBERGRAFT® BG Matrix is an osteoconductive, resorbable, biocompatible bone graft substitute composed of bioactive glass, mixed with Type I collagen. The FIBERGRAFT® BG Matrix is substantially equivalent to its predicate device for its intended use as a synthetic bone void filler.

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Performance testing, including in vivo data, demonstrated that the device functions as intended
without raising new safety or effectiveness questions.