ULTRAFUSE

K130531 · Baxter Healthcare Corp · MQV · Apr 8, 2014 · Orthopedic

Device Facts

• Record ID: K130531
• Device Name: ULTRAFUSE
• Applicant: Baxter Healthcare Corp
• Product Code: MQV · Orthopedic
• Decision Date: Apr 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system i.e., extremities and pelvis. ALTAPORE can be used in combination with autograft as a bone graft extender in the extremities and pelvis. ALTAPORE can be used in combination with autogenous bone marrow aspirate in the extremities and pelvis. 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. ALTAPORE resorbs and is replaced with bone during the healing process.

Device Story

ALTAPORE is a bioactive, osteoconductive bone void filler composed of silicate-substituted calcium phosphate (Ca, P, O, H, Si). Supplied as 1-2 mm microgranules in an absorbable aqueous gel carrier; does not set in-situ. Implanted by surgeons to fill skeletal voids in extremities and pelvis. Bioactivity demonstrated by apatite-layer formation in simulated body fluid; provides scaffold for bone growth. Osteoconductivity confirmed via animal critical defect models using radiographic, histopathological, and mechanical analyses. Device undergoes cell-mediated remodeling and replacement by natural bone. Used as standalone, autograft extender, or with bone marrow aspirate.

Clinical Evidence

No clinical data. Evidence based on non-clinical benchtop material characterization, dissolution, mechanical testing, in-vitro bioactivity, and in-vivo animal critical size defect models. Biocompatibility established per ISO 10993-1.

Technological Characteristics

Silicate-substituted calcium phosphate; 1-2 mm microgranules; 82.5% nominal porosity; microporous struts. Supplied in absorbable aqueous gel carrier. Sterilization via terminal irradiation. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities and pelvis) that are not intrinsic to the stability of the bony structure. Used as a standalone graft, autograft extender, or with autogenous bone marrow aspirate. Applicable to surgically created or traumatic osseous defects.

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

• Actifuse® ABX E-Z-fil Putty Bone Graft Substitute (K071206)
• Actifuse® Bone Graft Substitute (K081979)
• Actifuse® Bone Graft Substitute (K082575)

Submission Summary (Full Text)

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Traditional 510(k) Premarket Notification
K130531 - ALTAPORE

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Scetion 5, 510(k) Summary

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| 5. 510(K) SUMMARY | | | APR 08 2 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| DATE SUMMARY<br>PREPARED: | 23 January 2013 | | |
| OWNER: | Baxter Healthcare Corporation<br>One Baxter Way<br>Westlake Village, CA 91362 | | |
| CONTACT PERSON: | Jerzy Wojcik<br>Associate Director, Global Regulatory Affairs<br>Baxter Healthcare Corporation<br>One Baxter Way<br>Westlake Village, CA 91362 | Telephone: | 224-948-3954 |
| | | Fax: | 805-372-3082 |
| | | Email: | [e-mail] |
| DEVICE NAME: | Trade Name: | ALTAPORE | |
| | Common Name: | Bone Void Filler | |
| | Classification: | Resorbable calcium salt bone void filler devices have been<br>classified by the Orthopedics Device Panel as Class II<br>Special Controls per 21CFR888.3045 | |
| | Class: | Class II | |
| | Product Code: | MQV | |
| PREDICATE<br>DEVICES | K071206 | Actifuse® ABX E-Z-fil Putty Bone Graft Substitute | |
| | K081979 | Actifuse® Bone Graft Substitute<br>Actifuse® ABX E-Z-fil Putty Bone Graft Substitute<br>Actifuse® Shape Bone Graft Substitute<br>Actifuse® Flow Bone Graft Substitute | |
| | K082575 | Actifuse® Bone Graft Substitute<br>Actifuse® Microgranules Bone Graft Substitute<br>Actifuse® E-Z Prep<br>Actifuse® ABX E-Z-fil Putty Bone Graft Substitute<br>Actifuse® MIS<br>Actifuse® Shape Bone Graft Substitute | |

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## Traditional 510(k) Premarket Notification K130531 - ALTAPORE

# DEVICE DESCRIPTION:

ALTAPORE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicate-substituted calcium phosphate phase of ALTAPORE is similar to human cancellous bone and is intended to support bone growth with macroand micro- porosity. ALTAPORE is composed solely of elements that exist naturally in normal bone (Ca, P, O, H, Si). ALTAPORE is supplied in a sterile applicator and contains ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable aqueous gel carrier. ALTAPORE docs not set in-situ following implantation. ALTAPORE is available in 1.5ml, 2.5ml, 5ml, 10ml, and 20ml configurations.

AI,TAPORE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary. the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

ALTAPORE is bioactive based on in vitro studies that show it forms a surface apatite-layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect.

ALTAPORE is osteoconductive based on in vivo animal studies that show it achieves bony healing in a critical defect model as confirmed with radiographic, histolopatholgical, histomorphometric, and mechanical analyses. ALTAPORE undcrgocs ccll-mediated remodeling and is replaced by natural bone.

# STATEMENT OF INTENDED USE:

ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system i.e., extremities and pelvis. ALTAPORE can be used in combination with autograft as a bone graft extender in the extremities and pelvis. ALTAPORE can be used in combination with autogenous bone marrow aspirate in the extremities and pelvis. These osscous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

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# TECHNOLOGICAL CHARACTERISTICS:

| ELEMENT OF<br>COMPARISON | ALTAPORE | PREDICATE (ABX) |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Composition | Silicate-substituted<br>calcium phosphate<br>composed solely of<br>elements that exist<br>naturally in normal bone<br>(Ca, P, O, H, Si). | Silicate-substituted<br>calcium phosphate<br>composed solely of<br>elements that exist<br>naturally in normal bone<br>(Ca, P, O, H, Si). |
| Physical<br>Structure | Granules with a porosity<br>similar to cancellous bone | Granules with a porosity<br>similar to cancellous bone |
| Nominal (Total)<br>Porosity | $82.5 \pm 2.5%$ | $80.0 \pm 2.5%$ |
| Strut Porosity | Microporous | Microporous |
| Sterility | Terminal irradiation | Terminal irradiation |

#### ASSESSMENT OF NONCLINICAL DATA:

Testing has shown ALTAPORE to meet the requirements of relevant standards for Calcium Salt Bone Void Fillers. Testing has confirmed ALTAPORE to be safe and effective in providing a scaffold for rapid bone repair via hony infiltration of the porous scaffold. Non-clinical testing included benchtop material characterization, dissolution, and mechanical; as well as in-vitro hioactivity . Biocompatibility of the device has been established in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and Testing. Critical size defect implantation in-vivo animal studies have demonstrated that ALTAPORE is efficacious as a standalone bone graft substitute, mixed with Bone Marrow Aspirate (BMA), or mixed with autologous bone.

The conclusions drawn from the non-clinical tests demonstrate that CONCLUSIONS: ALTAPORE is as safe, as cffcctive, and performs as well or better than the predicate devices as a bioactive and osteoconductive bone void filler for osscous defects and is therefore substantially equivalent to the predicate devices. ALTAPORE is efficacious as a standalone bone graft substitute, mixed with Bone Marrow Aspirate (BMA), or mixed with autologous bone. The side-by-side comparative benchtop, in-vitro and in-vivo performance data provided showed no evidence of local or systemic adverse effects related to the device.

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Image /page/3/Picture/0 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 an abstract symbol that resembles three stylized human figures or waves.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10907 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 8, 2014

Baxter Healthcare Corporation Mr. Jerzy Wojcik Associate Director, Global Regulatory Affairs One Baxter Way Westlake Village, California 91362

Re: K130531

Trade/Device Name: ALTAPORE Regulation Number: 21 CFR 888,3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: March 13, 2014 Received: March 14, 2014

Dear Mr. Wojcik:

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 that I D. And Interes 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. Jerzy Wojcik

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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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Traditional 510(k) Premarket Notification K130531 - ALTAPORE

## 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

# K130531

Device Name:

### ALTAPORE

#### Indication(s) for Use:

ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system i.e., extremities and pelvis. ALTAPORE can be used in combination with autograft as a bone graft extender in the extremities and pelvis. ALTAPORE can be used in combination with autogenous bone marrow aspirate in the extremities and pelvis. 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. ALTAPORE resorbs and is replaced with bone during the healing process.

তি Prescription Use: 21 CFR 801 Subpart D

Over-the-Counter Use: I 21 CFR 801 Subparı C

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AND/OR

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -S

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(Division Sign-Off) Division of Orthopedia Devices 510(k) Number: K130531