SORRENTO BONE GRAFT SUBSTITUTE

K141429 · Haider Biologics, LLC · MQV · Feb 23, 2015 · Orthopedic

Device Facts

• Record ID: K141429
• Device Name: SORRENTO BONE GRAFT SUBSTITUTE
• Applicant: Haider Biologics, LLC
• Product Code: MQV · Orthopedic
• Decision Date: Feb 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate. Following placement in the bony you'd or gap (defect), Sorrento Bone Graft Substitute is resorbed and replaced with bone during the healing process.

Device Story

Sorrento Bone Graft Substitute is a resorbable bone void filler; consists of a matrix of highly purified collagen with dispersed beta tricalcium phosphate (TCP) granules. Device is provided sterile, non-pyrogenic, and for single use. Clinician wets the implant with patient's bone marrow aspirate before placement into skeletal voids or gaps in extremities or pelvis. Device acts as a scaffold; resorbs over time and is replaced by natural bone during the healing process. Used by surgeons in clinical settings to treat osseous defects from trauma or surgery. Benefits include providing a resorbable matrix to support bone regeneration.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing and an animal study (rabbit distal femoral defect model) evaluating radiographic and histomorphometric outcomes at 6 and 12 weeks.

Technological Characteristics

Resorbable bone void filler; matrix of highly purified collagen (ASTM F2212) with dispersed high-porosity beta tricalcium phosphate (TCP) granules (ASTM F1088). Physical form is a sponge. Sterile, single-use, non-pyrogenic.

Indications for Use

Indicated for patients requiring bone void filling in extremities and pelvis for non-structural osseous defects resulting from surgery or traumatic injury. Must be wetted with bone marrow aspirate prior to use.

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 Bone Graft Material (K032288)

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

February 23, 2015

Haider Biologics, LLC Gustavo R. Prado. PhD Vice President of R&D 9930 Mesa Rim Road San Diego, California 92121

Re: K141429

Trade/Device Name: Sorrento™ Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: January 22, 2015 Received: January 26, 2015

Dear Dr. Prado:

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 – Gustavo R. Prado, PhD

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 vours.

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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# Indications for Use

510(k) Number (if known) K141429

Device Name Sorrento™ Bone Graft Substitute

#### Indications for Use (Describe)

Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate. Following placement in the bony you'd or gap (defect), Sorrento Bone Graft Substitute is resorbed and replaced with bone during the healing process.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"> <span> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.235.235 0 0 1 .02-.022z" fill-rule="evenodd"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div style="display:flex; align-items:center;"> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## 510(k) Summary

#### Submitter:

Haider Biologics, LLC 9930 Mesa Rim Drive, San Diego, CA 92121

Phone: [phone] Fax: [phone]

Contact: Gustavo R. Prado, PhD Title: Vice President of R&D E-mail: [e-mail]

#### Date Prepared:

February 18, 2015

#### Subject Device:

Trade Name: Sorrento™ Bone Graft Substitute Common Name: Bone Void Filler

Classification Name: Resorbable Calcium Salt Bone Void Filler Device Regulation: 21 CFR 888.3045

Device Class: Class II Product Code: MQV Review Panel: Orthopedic

#### Predicate Devices:

| 510(k) # | Trade Name | Product Code |
|----------|----------------------------------------------------------------|--------------|
| K032288 | Vitoss® Scaffold Foam Bone Graft Material<br>(Orthovita, Inc.) | MQV |

#### Device Description:

Sorrento Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) dispersed throughout. The implant is provided as sterile, non-pyrogenic, and for single use in double peel packages.

#### Indications for Use:

Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate. Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitute is resorbed and replaced with bone during the healing process.

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### Technological Characteristics:

The subject device is substantially equivalent to the cited legally marketed predicate device. The subject device has the same technological characteristics including design, materials, operating principle and indications for use.

#### Chart comparing subject device to the predicate device:

| Characteristic | Substantially Equivalent? | Impact on Safety &<br>Performance |
|---------------------------------|---------------------------|-----------------------------------|
| Design | YES | None |
| Material Characterization | YES | None |
| Biocompatibility | YES | None |
| Sterilization | YES | None |
| Components of Device (Material) | YES | None |
| Dimensional Specifications | YES | None |
| Physical Form (Sponge) | YES | None |

### Non-Clinical Testing:

Distal femoral defect model in rabbits was used to compare the subject device to the predicate device at 6 and 12 weeks following implantation. Performance was evaluated radiographically and histomorphometrically. Study data demonstrated that the subject device is substantially equivalent with the predicate device.

In addition, substantial equivalence of the Sorrento Bone Graft Substitute was supported by evaluation per ASTM F1088 (for beta tricalcium phosphate) and ASTM F2212 (for collagen).

#### Clinical Testing:

Clinical performance data were not required to determine substantial equivalence

#### Conclusions:

Conclusions drawn from the non-clinical tests demonstrated that the subject device possessed at least equivalent performance characteristics as the predicate device, and that overall the subject device is substantially equivalent.