MCP Bone Putty

K160446 · Biostructures, LLC · MQV · Nov 7, 2016 · Orthopedic

Device Facts

• Record ID: K160446
• Device Name: MCP Bone Putty
• Applicant: Biostructures, LLC
• Product Code: MQV · Orthopedic
• Decision Date: Nov 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MCP Bone Putty is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCP Bone Putty is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCP Bone Putty is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.

Device Story

MCP Bone Putty is a resorbable bone graft substitute consisting of biphasic mineral granules (hydroxyapatite and beta-tricalcium phosphate) suspended in a porous type I bovine collagen matrix. Supplied sterile for single-patient use, the device is hydrated with autologous bone marrow aspirate by the surgeon before being packed into osseous defects. It acts as an osteoconductive scaffold, guiding host bone regeneration while resorbing over time. Used in clinical settings for orthopedic and spinal procedures, it assists in bone healing and fusion. The device provides a physical matrix that supports bone growth, reducing the need for larger volumes of autograft bone.

Clinical Evidence

No human clinical data. Evidence based on non-clinical bench testing and animal studies. Bench testing confirmed compliance with ASTM F1185-03, F1088-04a, F2212-11, and ISO 10993 biocompatibility. Animal studies included a rabbit femoral defect model (N=19) and a rabbit posterolateral spine fusion model (N=25). Assessments included macroscopic, radiographic, microCT, biomechanical, and histological evaluations. Results demonstrated safety and performance equivalent to predicate devices (Vitoss, Mastergraft) and autograft controls, with no device-related adverse reactions observed.

Technological Characteristics

Biphasic mineral granules (hydroxyapatite and beta-tricalcium phosphate) in porous type I bovine collagen matrix. Porosity >90%. Complies with ASTM F1185-03, F1088-04a, F2212-11. Biocompatibility per ISO 10993; animal tissue safety per ISO 22442. Supplied sterile.

Indications for Use

Indicated for patients requiring bone graft substitutes for bony voids or gaps in the skeletal system (extremities, pelvis, posterolateral spine) not intrinsic to stability. Used as an autograft extender in the posterolateral spine. Must be combined with autologous 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 Foam Bone Graft Substitute (K032288)
• MCS Bone Graft (K142276)
• Mastergraft® Putty (K071813)

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

November 7, 2016

BioStructures, LLC % Ms. Patsy J. Trisler Regulatory Consultant Trisler Consulting 5600 Wisconsin Ave Chevy Chase, Maryland 20815

Re: K160446

Trade/Device Name: MCP Bone Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: September 23, 2016 Received: September 23, 2016

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 (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

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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/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 yours,

# Vincent J. Devlin -S

for

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

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

510(k) Number (if known) K160446

Device Name

MCP Bone Putty

#### Indications for Use (Describe)

MCP Bone Putty is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCP Bone Putty is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCP Bone Puty is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.

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

| <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------|
| <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## Section 5 510(k) Summary

## Submitter Information:

| Name: | BioStructures, LLC |
|-----------------|---------------------------------------------------------|
| Address: | 1201 Dove Street, Suite 470<br>Newport Beach, CA 92660 |
| Contact Person: | John Brunelle, PhD<br>Chief Technology Officer |
| Telephone: | [phone] |
| Date Prepared: | February 17, 2016 |

## Device Information:

| Trade Name: | MCP Bone Putty |
|-----------------|-----------------------------------------------------------|
| Common Name: | Bone void filler/ Bone graft substitute |
| Classification: | Class 2 |
| Regulation: | 888.3045, Resorbable calcium salt bone void filler device |
| Product Code: | MQV |

## Predicate Device(s):

K032288: Vitoss Foam Bone Graft Substitute (Orthovita, Inc.) K142276: MCS Bone Graft (BioStructures, LLC) K071813: Mastergraft® Putty (Medtronic Sofamor Danek)

### Indications for Use:

MCP Bone Putty is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCP Bone Putty is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCP Bone Putty is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.

### Device Description:

MCP Bone Putty is a bone graft substitute comprising biphasic mineral granules suspended in a porous type I collagen matrix, provided terminally sterile and for single patient use. The device is to be combined with autologous bone marrow aspirate to facilitate packing into bony defects and upon implantation, provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.

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## Performance Testing:

Non-clinical testing was performed in accordance with FDA guidance documents and recognized consensus standards as applicable. Physical and chemical characterization of the implant raw materials and finished device was conducted as recommended in the FDA class II bone void filler guidance document and meet relevant requirements of ASTM F1185-03, F1088-04a and F2212-11. The collagen raw materials meet essential safety requirements for medical devices utilizing animal tissues according to ISO 22442. The device has met all ISO 10993 biocompatibility requirements relevant to bone void filler devices. Viral inactivation, packaging and shelf life stability evaluations have been performed with passing results.

Animal performance testing was conducted using established rabbit defect models to evaluate the safety and performance of the MCP Bone Putty as directly compared to the predicate devices, as described below.

### Femoral Defect Animal Study

The device was evaluated in a critical-sized bilateral femoral defect rabbit model in comparison to the Vitoss predicate. The study included 14 defect sites implanted with the MCP Bone Putty and 12 defect sites for the predicate (19 rabbits total), evaluated at time points of 1 day, 6 weeks and 12 weeks after surgery. Both test groups were fully hydrated with autologous bone marrow aspirate prior to implantation. Defects were created in the medial femoral condyles of each rabbit using a surgical drill bit, followed by implantation of the hydrated graft materials. There were no device-related adverse reactions observed regardless of test group or time point. The safety and performance of MCP Bone Putty were evaluated via macroscopic, radiographic, microCT and histological assessments of the implant site. The study demonstrated that the MCP Bone Putty can safely support bone healing in critical-sized femoral defects in equivalence to the Vitoss predicate device.

### Posterolateral Spine Fusion Animal Study

The device was evaluated in a posterolateral spine fusion rabbit model in comparison to the Mastergraft Putty predicate device, as well as a control group using autologous iliac crest bone graft. The study included 25 rabbits and per test group, evaluated at 4 weeks (N=8) and 12 weeks (N=12) after surgery. Both the MCP Bone Putty and predicate test groups were fully hydrated with autologous bone marrow aspirate and admixed with autograft bone prior to implantation. Graft materials were implanted bilaterally across the L5-L6 transverse processes. There were no devicerelated adverse reactions observed regardless of test group or time point. The safety and performance of MCP Bone Putty were evaluated via macroscopic, radiographic, microCT, biomechanical and histological assessments of the fusion site. The study demonstrated that the MCP Bone Putty, when used as an autograft extender, can safely support spine fusion healing in equivalence to both the Mastergraft Putty predicate and iliac crest autograft control.

## Substantial Equivalence:

MCP Bone Putty has the same intended use, and the same or similar technological characteristics, principles of operation and indications as the predicate devices. MCP Bone Putty, MCS Bone Graft and Mastergraft Putty are all comprised of biphasic mineral granules (mixture of hydroxyapatite and Btricalcium phosphate) and bovine type I collagen. Similarly, the Vitoss predicate comprises β-tricalcium phosphate granules and bovine type I collagen. MCP Bone Putty is provided in strip form, similar to all predicates, and has >90% implant porosity, same as the MCS Bone Graft and Vitoss predicates. The MCP Bone Putty finished device is supplied sterile and is combined with bone marrow aspirate prior

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to use, same as all predicates. MCP Bone Putty is to be used as an autograft extender when used in the posterolateral spine, same as Mastergraft Putty. Any technological differences presented by the MCP Bone Putty do not raise new issues of safety or effectiveness, as demonstrated by the comparative evaluation in the animal studies.

## Conclusion:

Performance testing and technological comparisons presented in the 510(k) indicate MCP Bone Putty is substantially equivalent to the predicate devices.