SOLUM IV BONE VOID FILLER

K132470 · Spinesmith Partners, Llp · MQV · May 21, 2014 · Orthopedic

Device Facts

• Record ID: K132470
• Device Name: SOLUM IV BONE VOID FILLER
• Applicant: Spinesmith Partners, Llp
• Product Code: MQV · Orthopedic
• Decision Date: May 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Solum IV ® is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities and pelvis) in conjunction with an equal volume of bone marrow aspirate. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Device Story

Solum IV is a resorbable, osteoconductive bone void filler composed of porous hydroxyapatite granules and a porcine gelatin carrier. Provided sterile, the device is hydrated and mixed with an equal volume of patient bone marrow aspirate to form a cohesive, putty-like dough. Surgeons pack the material into non-structural bony voids or gaps in the extremities or pelvis. The scaffold provides a multidimensional porous structure similar to human cancellous bone, facilitating new bone in-growth while the material resorbs during the healing process. The device is intended for clinical use by surgeons to fill osseous defects resulting from surgery or trauma.

Clinical Evidence

No human clinical data provided. Evidence consists of non-clinical testing including chemical, physical, and biocompatibility assessments. A critically sized defect animal study was conducted to evaluate in vivo performance, demonstrating that Solum IV performed as well as the predicate device.

Technological Characteristics

Composed of >95% hydroxyapatite (HAp) macroporous ceramic granules and Type A porcine gelatin carrier. Granule size 0.5mm-2.5mm; Ca/P ratio 1.66; 80% porosity. Supplied as ground particles in double-sealed packaging with a mixing spatula. Resorbable osteoconductive scaffold. No electronic or software components.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities and pelvis) not intrinsic to structural stability. Used for surgically created osseous defects or traumatic bone injuries. Requires mixing with equal volume of 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

• nanOss BVF-E (K081558)

Submission Summary (Full Text)

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#### MAY 2 1 2014 SpineSmith Solum IV ® Bone Void Filler, Bone Graft Substitute

| 510(k) Summary of Safety and Effectiveness | |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY | SpineSmith Partners, LLP<br>93 Red River<br>Austin, TX 78701 |
| ESTABLISHMENT<br>REGISTRATION NUMBER | 3006404071 |
| CONTACT PERSON | Clifton (Chris) Naivar<br>Director - Quality and Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| SUBMISSION PREPARED BY | Clifton (Chris) Naivar<br>Director - Quality and Regulatory Affairs<br>Phone: [phone] |
| DATE PREPARED | May 14, 2014 |
| CLASSIFICATION | Class II<br>MQV - Resorbable calcium salt bone void filler device.<br>888.3045 |
| COMMON NAME | Filler, bone void, calcium compound |
| PROPRIETARY NAME | Solum IV Bone Void Filler |

#### IDENTIFICATION OF PREDICATE DEVICES:

Solum IV was determined to be substantially equivalent to the previously cleared nanOss BVF-E. K081558. Pioneer Surgical Technology. Cleared August 25. 2008. Solum IV is similar to nanOss BVF-E in characteristics which includes indication, ceramic materials, gelatin carrier, structure and presentation.

#### DEVICE DESCRIPTION:

Solum IV ® is a resorbable porous calcium phosphate bone void filler mixed with a porcine gelatin based carrier. It is an osteoconductive implant with a multidimensional porosity similar to human cancellous bone and acts as a scaffold for the in-growth of new bone.It is provided sterile in various configurations within a double sealed package containing a mixing spatula.

## INDICATIONS:

Solum IV ® is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities and pelvis) in conjunction with an equal volume of bone marrow

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aspirate. These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

### TECHNOLOGICAL CHARACTERISTICS:

Solum IV ® is composed of porous hydroaxyapatite granules and a Type A porcine gelatin based carrier. The granules consist of macroporous ceramic granules composed of greater than 95% hydroxyapatite (HAp). The calcium phosphate granuals are presented as ground particles. The macroporous sturcture of Solum IV provides a resorbable osteoconductive scaffold.

The gelatin based carrier is presented as ground freeze-dried particles. The product forms a cohesive and adhesive dough with a putty-like consistency upon hydration which allows the shape of the implant to conform to the defect maximizing direct contact with viable host bone.

A summay of the technological characteristics comparing Solum IV to the predicate nanOss BVF-E (K081558) is listed in the table below.

| Specification | Solum IV | Predicate<br>nanOss |
|---------------------------------------------|---------------------------|---------------------------|
| Device Material | Type A Gelatin<br>and HAp | Type A Gelatin<br>and HAp |
| Particle Size | .5mm-2.5mm | .5mm-2.5mm |
| Ca/P Ratio | 1.66 | 1.66 |
| Porosity<br>(As determined<br>by % Density) | 80% | 71% |
| Crystalline<br>Structure | >95% | >95% |

#### TESTING:

Solum IV and/or its components have undergone non-clinical testing including chemical. physical, animal, component biocompatibility, and handling characteristics. A critically sized defect implantation animal study demonstrated that Solum IV performed as well as the predicate device. Testing has provided a reasonable assurance of safety and effectiveness for its intended use with respect to the predicate device and supports a determination of substantial equivalence to the predicate device.

#### CONCLUSIONS:

The comparisons and testing conducted on Solum IV demonstrate that Solum IV and the predicated device nanOss BVF-E (K081558) have similar technological characteristics, intended use, and in vivo performance in a critically sized defect animal study, and therefore are substantially equivalent.

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Public Health Service

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three overlapping shapes representing arms or wings.

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

May 21, 2014

SpineSmith Partners, LLP Mr. Clifton (Chris) Naivar Director, Quality and Regulatory Affairs 93 Red River Street Austin, Texas 78701

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re: K132470

Trade/Device Name: Solum IV Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: April 14, 2014 Received: April 15, 2014

Dear Mr. Naivar:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Mr. Clifton (Chris) Naivar

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" (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/Resourcesfor You/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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# K132470 - page 1 of 1

# INDICATIONS FOR USE

510(k) Number (if known): K132470

Device Name: Solum IV Bone Void Filler

Indications for Use:

Solum IV ® is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities and pelvis) in conjunction with an equal volume of bone marrow aspirate. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Laurence D. Coyne -A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132470