MCS Bone Graft

K142276 · Biostructures, LLC · MQV · Jan 16, 2015 · Orthopedic

Device Facts

• Record ID: K142276
• Device Name: MCS Bone Graft
• Applicant: Biostructures, LLC
• Product Code: MQV · Orthopedic
• Decision Date: Jan 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MCS Bone Graft is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MCS Bone Graft is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities and pelvis) and is used mixed with bone marrow aspirate. Once implanted, the device resorbs and is replaced with host bone during the healing process.

Device Story

MCS Bone Graft is a resorbable bone void filler; consists of biphasic mineral granulate suspended in porous type I collagen matrix. Supplied freeze-dried in strip form; hydrated with bone marrow aspirate by clinician prior to implantation. Used in healthcare facilities/hospitals for filling non-structural bony voids or gaps in extremities and pelvis. Acts as an osteoconductive scaffold; resorbs over time; replaced by host bone during healing. Benefits patient by facilitating bone regeneration in osseous defects.

Clinical Evidence

No human clinical data. Bench testing included raw material characterization (ASTM F1185-03, F1088-04a, F2212-11), biocompatibility (ISO 10993), and packaging/sterilization/shelf-life validation (ISO 11607, ISO 11137, ASTM F2096-11, F88-09, F1980). Animal performance testing in a rabbit femoral cancellous defect model demonstrated equivalent safety, graft resorption, and new bone formation compared to predicate.

Technological Characteristics

Resorbable bone void filler; biphasic mineral granulate in type I collagen matrix. Materials conform to ASTM F1185-03, F1088-04a, F2212-11. Supplied sterile, freeze-dried, single-use. Osteoconductive scaffold mechanism.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities and pelvis) not intrinsic to structural stability; defects may be surgically created or traumatic. Used mixed with bone marrow aspirate.

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® Scaffold Foam Pack (K032288)
• MBCP™ (K051774)

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.

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

BioStructures, LLC % Patsy J. Trisler, JD, RAC Regulatory Consultant Trisler Consulting 5600 Wisconsin Avenue, #509

Chevy Chase, Maryland 20815

January 16, 2015

Re: K142276

Trade/Device Name: MCS Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: December 8, 2014 Received: December 9, 2014

Dear Ms. Trisler:

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

{1}------------------------------------------------

Page 2 - Patsy J. Trisler. JD. RAC

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 [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

{2}------------------------------------------------

### Indications for Use

| 510(k) Number (if known): | K142276 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: MCS Bone Graft

#### Indications for Use:

MCS Bone Graft is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MCS Bone Graft is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities and pelvis) and is used mixed with bone marrow aspirate. Once implanted, the device resorbs and is replaced with host bone during the healing process.

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

| X Prescription Use<br>(Part 21 CFR 801 Subpart D) | _ Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|---------------------------------------------------|--------------------------------------------------|
|---------------------------------------------------|--------------------------------------------------|

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

#### FOR FDA USE ONLY

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

{3}------------------------------------------------

## Section 5 510(k) Summary

| Submitter Name: | BioStructures, LLC |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 1201 Dove Street, Suite 470<br>Newport Beach, CA 92660 |
| Contact Person: | John Brunelle, Ph.D.<br>Chief Technology Officer |
| Phone Number: | 949.553.1717 |
| Date Prepared: | August 14, 2014 |
| Device Trade Name: | MCS Bone Graft |
| Common Name:<br>Classification Name: | Bone void filler |
| | Resorbable Calcium Salt Bone Void Filler Device |
| Classification Number: | 21 CFR 888.3045 |
| Product Code: | MQV |
| Device Class: | 2 |
| Predicate Device(s): | K032288, Vitoss® Scaffold Foam Pack, Stryker/Orthovita<br>K051774, MBCP™, Biomatlante |
| Indications for Use<br>Statement: | MCS Bone Graft is a bone void filler device intended for use in bony voids<br>or gaps that are not intrinsic to the stability of the bony structure. These<br>defects may be surgically created osseous defects or osseous defects<br>created from traumatic injury to the bone. MCS Bone Graft is indicated to<br>be packed gently into bony voids or gaps of the skeletal system (i.e.,<br>extremities and pelvis) and is used mixed with bone marrow aspirate.<br>Once implanted, the device resorbs and is replaced with host bone during<br>the healing process. |
| Device Description: | Device Identification and Materials of Use:<br>MCS Bone Graft is a resorbable bone void filler device comprised of<br>biphasic mineral granulate suspended in a porous type I collagen matrix.<br>Device Characteristics:<br>The implant is designed to be hydrated with bone marrow aspirate prior<br>to implantation to facilitate handling and placement in bony defects. The<br>device is supplied freeze dried in strip form, and packaged in a sterile<br>barrier foil pouch. The device is provided sterile, for single use, in a<br>variety of sizes.<br>Body Contact: |
| | The device is a permanent resorbable implant in bone tissue |

{4}------------------------------------------------

Mechanism of Action:

The device's composition allows for resorption and remodeling over time. It is an osteoconductive scaffold for new bone regeneration.

Environment of Use:

The device is for use only in a health care facility/hospital.

Summary of Testing: Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidance documents as applicable.

> Raw materials characterization testing was performed according to ASTM standards: F1185-03, F1088-04a, F2212-11.

Biocompatibility testing, according to ISO 10993 for a long-term implant product, demonstrated the device is biocompatible and non-toxic.

Packaging, sterilization and shelf life testing according to the following standards are presented in the 510(k):

- Packaging: ISO 11607, ASTM F2096-11 & F88-09, and ISO 11137.
- . Sterilization and Shelf Life; ISO 11137 and ASTM F1980.

Animal performance testing was performed in a femoral cancellous defect rabbit model to evaluate the safety and performance of the MCS Bone Graft compared to a predicate device. The test results showed equivalent in vivo performance in safety, graft resorption and new bone formation.

Comparison to the MCS Bone Graft has the same intended use and the same principles of Predicate Devices: operation as all the predicates, which serve as osteoconductive scaffolds for new bone formation.

MCS Bone Graft is similar technologically to the two predicates.

The technological differences presented by the composition of materials in MCS Bone Graft do not raise new issues of safety or effectiveness, as demonstrated by the side-by-side evaluation in the animal performance studies.

- Substantial Equivalence The comparisons and study data presented in the 510(k) lead to the Conclusion: conclusion that MCS Bone Graft is substantially equivalent to the predicate devices.