OSTEOSPAN MORPHEUS

K132377 · Biogennix, LLC · MQV · May 20, 2014 · Orthopedic

Device Facts

• Record ID: K132377
• Device Name: OSTEOSPAN MORPHEUS
• Applicant: Biogennix, LLC
• Product Code: MQV · Orthopedic
• Decision Date: May 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BIOGENNIX osteoSPAN Morpheus is indicated for bony voids or gaps that are not intrinsic to the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

Device Story

osteoSPAN Morpheus is a moldable, osteoconductive bone graft substitute; composed of 1-2mm calcium carbonate/calcium phosphate composite granules suspended in a resorbable organic binder. Granules feature interconnected porosity (approx. 500 microns, 65% volume). Binder facilitates surgical placement and containment; resorbs in-situ. Used by surgeons to fill non-structural bony voids or gaps in extremities and pelvis; defects may be surgically created or traumatic. Provides scaffold for bone ingrowth; resorbs and is replaced by natural bone during healing. No complex electronics or software involved.

Clinical Evidence

No clinical data. Safety and performance established via bench testing, including chemical and physical characterization, and non-clinical in-vivo and ex-vivo studies.

Technological Characteristics

Bone void filler; material: calcium carbonate/calcium phosphate composite granules with hydroxyapatite coating; organic binder; 1-2mm granule size; 65% porosity; 500-micron pore diameter. Biocompatibility per ISO 10993.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities and pelvis) not intrinsic to bony stability. Defects may be surgically created or result from traumatic injury.

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

• osteoSPAN (K093342)
• Actifuse ABX E-Z Fil Putty (K071206)

Submission Summary (Full Text)

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## 510(K) SUMMARY

#### Submitted on behalf of:

#### BIOGENNIX, LLC Company Name: 18011 Sky Park Circle, Ste M Address: Irvine, CA 92614 949-253-0094 Telephone: Fax: [phone] Elaine Duncan, M.S.M.E., RAC by: President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 715-549-6035 Telephone: [phone] Fax: CONTACT PERSON: Elaine Duncan May 12, 2014 DATE PREPARED: osteoSPAN Morpheus TRADE NAME: bone void filler COMMON NAME: 21 CFR 888.3045: CLASSIFICATION NAME:

PRO CODE:

Resorbable calcium salt bone void-filler device MQV

#### DESCRIPTION of the DEVICE:

osteoSPAN Morpheus is a moldable, osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules suspended in a resorbable organic binder. The osteoSPAN granules used in osteoSPAN Morpheus are a composite of calcium carbonate with a thin calcium phosphate layer, in the form of hydroxyapatite, coating on all the surfaces of the interconnected porosity. The interconnected pores are approximately 500 microns in diameter and occupy approximately 65% of the volume. The biocompatible, organic binder facilitates placement and containment of the implant and is rapidly resorbed in-situ, leaving behind the osteoSPAN granules without affecting their osteoconductive or resorbable properties.

#### INDICATIONS FOR USE:

BIOGENNIX osteoSPAN Morpheus is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created

## MAY 2 0 2014

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#### 510(k) Summary-Continued

from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

| Product | Calcium Salt | Granule<br>Size | Porosity | Polymer<br>Binder | Osteo-<br>conductive |
|---------------------------|------------------------------------------------------|-----------------|----------|-------------------|----------------------|
| osteoSPAN<br>Morpheus | Calcium carbonate/<br>calcium phosphate<br>composite | 1-2mm | 65% | Yes | Yes |
| osteoSPAN<br>(K093342) | Calcium carbonate/<br>calcium phosphate<br>composite | 1-4mm | 65% | No | Yes |
| Actifuse ABX<br>(K071206) | Silicate substituted<br>calcium phosphate | 1-2mm | 80% | Yes | Yes |

#### SUMMARY of HOW TECHNOLOGICAL CHARACTERISTICS COMPARE:

#### CONCLUSION FROM TESTING:

Chemical and physical testing confirmed acceptable findings and were consistent with prior osteoSPAN predicate device qualifications. Biogennix osteoSPAN Morpheus was thoroughly evaluated for biocompatibility in accordance with ISO 10993 appropriate parts and for performance, through multiple non-clinical in-vivo and ex-vivo studies. These studies conclusively demonstrate that osteoSPAN Morpheus is safe and performs as well as the primary predicate: osteoSPAN granules and like the material-reference: Actifuse ABX E-Z Fil Putty.

#### SUBSTANTIALLY EQUIVALENT TO:

The contents of this submission have demonstrated that osteoSPAN Morpheus is substantially equivalent to Biogennix osteoSPAN granules (primary predicate) (K093342) and to the material-reference predicate: Actifuse ABX E-Z-fil Putty (K071206) manufactured by Apatech, Ltd.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Flampshire Avenue Document Control Center - WO66-G609 Silver Spring, Mi) 20993-0002

May 20, 2014

Biogennix. LLC % Ms. Elaine Duncan President Paladin Medical®, Incorporated P.O. Box 560 Stillwater, Minnesota 55082

Re: K132377

Trade/Device Name: osteoSPAN Morpheus Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: April 11, 2014 Received: April 14, 2014

Dear Ms. Duncan:

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

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#### Page 2 -- Ms. Elaine Duncan

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/ResourcesforYou/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/Reportal?roblem/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,

### Lori A. Wiggins

for 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 below.

#### 510(k) Number (if known) K132377

#### Device Name

osteoSPAN Morpheus

Indications for Use (Describe)

BIOGENNIX osteoSPAN Morpheus is indicated for bony voids or gaps that are not intrinsic to the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

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

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