MaxiGen

K152077 · Hans Biomed Corp. · MQV · Apr 21, 2016 · Orthopedic

Device Facts

• Record ID: K152077
• Device Name: MaxiGen
• Applicant: Hans Biomed Corp.
• Product Code: MQV · Orthopedic
• Decision Date: Apr 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MaxiGen™ is an implant intended to fill bony voids or gaps of the skeletal system i.e., posterolateral spine. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MaxiGen™ resorbs and is replaced with bone during the healing process

Device Story

MaxiGen™ is a resorbable bone void filler kit containing human demineralized bone matrix (DBM), calcium sulfate, and carboxymethylcellulose (CMC). Supplied as a powder with a mixing solution, tools, and a 5cc syringe; clinician hydrates components to form a putty. Used in institutional or hospital settings by surgeons to fill osseous defects in the skeletal system, including the posterolateral spine. The device acts as an osteoconductive scaffold for new bone regeneration and provides osteoinductive potential via DBM. It resorbs over time, remodeling into new bone. The device is intended for permanent implantation in bone tissue.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing and animal studies: biocompatibility per ISO 10993; osteoconduction performance in an in vivo rabbit spinal model; osteoinductive potential in an athymic (nude) rat muscle pouch model; and in vitro BMP-2 ELISA surrogate assay for lot-to-lot consistency.

Technological Characteristics

Resorbable bone void filler composed of human demineralized bone matrix (DBM), calcium sulfate, and carboxymethylcellulose (CMC). Supplied as a sterile kit for manual hydration. Permanent implant for bone tissue. Biocompatibility tested per ISO 10993.

Indications for Use

Indicated for filling surgically created or traumatic bony voids or gaps in the skeletal system, specifically the posterolateral spine, where the defect is not intrinsic to bony structure stability.

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

• ALLOMATRIX® Putty (K020895)
• ALLOMATRIX® Custom Putty (K053319)
• SurFuse™ Gel & Putty and ExFuse™ Gel & Putty (K113728)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

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

Hans Biomed Corporation % Ms. Patsy J. Trisler, JD, RAC Regulatory Consultant Trisler Consulting 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815

April 21, 2016

Re: K152077

Trade/Device Name: MaxiGen™ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: March 15, 2016 Received: March 15, 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/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

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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) K152077

Device Name

MaxiGen™

Indications for Use (Describe)

MaxiGer™ is an implant intended to fill bony voids or gaps of the skeletal system i.e., posterolateral spine. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MaxiGen™ resorbs and is replaced with bone during the healing process

100 - 100 - 100

| Type of Use (Select one or both, as applicable) | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <table style="border:none"><tr><td><span> <div style="display:inline-block; vertical-align:middle;"> <div style="display:inline-block; width:16px; height:16px; border:1px solid black; text-align:center;"> <b>X</b> </div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span></td><td><span> <div style="display:inline-block; vertical-align:middle;"> <div style="display:inline-block; width:16px; height:16px; border:1px solid black;"></div> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table> | <span> <div style="display:inline-block; vertical-align:middle;"> <div style="display:inline-block; width:16px; height:16px; border:1px solid black; text-align:center;"> <b>X</b> </div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <div style="display:inline-block; vertical-align:middle;"> <div style="display:inline-block; width:16px; height:16px; border:1px solid black;"></div> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
| <span> <div style="display:inline-block; vertical-align:middle;"> <div style="display:inline-block; width:16px; height:16px; border:1px solid black; text-align:center;"> <b>X</b> </div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <div style="display:inline-block; vertical-align:middle;"> <div style="display:inline-block; width:16px; height:16px; border:1px solid black;"></div> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |

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# Section 5.0 510(k) SUMMARY

| Submitter Name: | Hans Biomed Corp. |
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| Submitter Address: | 64, Yuseong-Daero 1628Beon-Gil, Yuseong-Gu, Korea,<br>Republic of, 305-811 |
| Contact Person: | Ms. Lucy Choi |
| Phone Number: | 0082 2 466 2266 |
| Fax Number: | 0082 2 463 1554 |
| Date Prepared: | July 27, 2015 |
| Device Trade Name: | MaxiGen™ |
| Device Common Name: | Resorbable Calcium Salt Bone Void Filler |
| Classification Number: | 21 CFR 888.3045 |
| Product Code: | MQV, MBP |
| Classification Name: | Filler, bone void, calcium compound |
| Device Class: | II |
| PREDICATE DEVICES | K020895, ALLOMATRIX® Putty,<br>Wright Medical Technology, Inc<br>K053319, ALLOMATRIX® Custom Putty,<br>Wright Medical Technology, Inc<br>K113728, SurFuse™ Gel & Putty and ExFuse™ Gel & Putty,<br>Hans Biomed Corp. |
| STATEMENT OF<br>INTENDED USE | MaxiGen™ is an implant intended to fill bony voids or gaps of the<br>skeletal system i.e., posterolateral spine. These osseous defects are<br>surgically created or the result of traumatic injury to the bone and<br>are not intrinsic to the stability of the bony structure. MaxiGen™<br>resorbs and is replaced with bone during the healing process |
| DEVICE DESCRIPTION | Device Identification, Materials of Use and Characteristics:<br>MaxiGen™ is a resorbable bone void filler, combining Human<br>Demineralized Bone Matrix (DBM) with calcium sulfate and<br>carboxymethylcellulose (CMC).<br>MaxiGen™ comes in the form of a kit with a premeasured and<br>premixed DBM, calcium sulfate, and CMC powder, premeasured<br>mixing solution, the tools for mixing the components, and a 5cc<br>syringe. After the powder is hydrated using all the mixing solution<br>supplied in the kit, the resultant putty can then be handled and<br>placed in the appropriate bone voids, or it can be injected using the<br>syringe supplied in the kit. This product is supplied sterile for |
| SUMMARY OF<br>TESTING<br>Serological Testing &<br>Biocompatibility: | The donor bone is obtained from AATB-certified tissue banks in<br>the United States and screened for:<br>Antibodies to the Human Immunodeficiency Virus, Type 1<br>and Type 2 (anti-HIV-1 and anti-HIV-2); Nucleic Acid Test (NAT) for HIV-1; Hepatitis B Surface Antigen (HBsAg); Total antibodies to Hepatitis B core antigen (anti-HBc-<br>total); Antibodies to the Hepatitis C Virus (anti-HCV); Nucleic Acid Test (NAT) for HCV; Syphilis |
| | Further the manufacturing and sterilization processes were assessed<br>for viral inactivation potency by a validation assessment which<br>included Human Immunodeficiency Virus-1 (HIV-1), Bovine<br>Herpes Virus (BHV), Bovine Viral Diarrhea Virus (BVDV),<br>Hepatitis A Virus (HAV) and Porcine Parvovirus (PPV). The<br>validation assessment observed complete inactivation of inoculated<br>viral titers. |
| | Biocompatibility testing, according to ISO 10993, has been<br>performed and the device has been shown to be safe, non-toxic and<br>biocompatible. |
| Performance: | Osteoconduction and Performance as a Bone Void Filler:<br>MaxiGen™ was tested successfully to fully assess the performance<br>to grow bone in the <i>in vivo</i> rabbit spinal model.<br>Osteoinductive Potential:<br>The device also has been tested <i>in vivo</i> in the athymic (nude) rat<br>muscle pouch model and were shown to have osteoinductive |

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# Body Contact:

MaxiGen™ is a permanent resorbable device, implanted in bone tissue.

### Mechanism of Action:

This device resorbs over time and remodels providing an osteoconductive scaffold for regeneration of new bone. In addition, because it contains DBM, it has osteoinductive potential.

# Environment of Use:

MaxiGen™ is for use only in institutional health care or hospital environments.

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potential, in that new bone grew within the muscle tissue. The osteoinductive potential also was evaluated with a surrogate, in vitro BMP-2 ELISA, assay. Results from that assay were correlated with results from the same lots in which bone successfully formed in the athymic rat. Each lot of MaxiGen™ device will be evaluated for osteoinductive potential using the in vitro assay.

Osteoinduction assay results observed in surrogate assessments should not be interpreted to predict clinical performance in human subjects.

#### MaxiGen™ has the same intended use as a bone void filler as all COMPARISON TO PREDICATE DEVICES: three predicate devices, and the same indication for use in posterolateral spine fusion procedures as the two supporting predicate devices.

MaxiGen™ has the same material composition as the primary predicate, AlloMatrix® Putty. The other two predicates also include cancellous bone and the SurFuse™/ExFuse™ predicate does not contain calcium sulfate. All contain CMC as the carrier.

With respect to device form and packaging, MaxiGen™ is substantially equivalent to all three predicate devices.