OSTEOPHIL BETA-TCP

K102937 · Cytophil, Inc. · MQV · Dec 27, 2010 · Orthopedic

Device Facts

• Record ID: K102937
• Device Name: OSTEOPHIL BETA-TCP
• Applicant: Cytophil, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Dec 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Osteophil B-TCP is a resorbable bone void filler intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Device Story

Osteophil B-TCP is a porous, synthetic, resorbable bone void filler composed of beta-Tricalcium Phosphate (B-TCP). It features a multidirectional interconnected porosity structure mimicking human cancellous bone. Available as 1-4 mm granules, the device is implanted by surgeons into bony defects in the extremities, posterolateral spine, or pelvis. Once implanted, the material slowly resorbs during the natural bone remodeling and repair process, facilitating progressive replacement by host bone and soft tissues. The interconnected porosity is designed to support bone in-growth while preventing premature resorption. It is intended for non-load-bearing applications where the bone defect is not intrinsic to the stability of the bony structure.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and animal studies. Bench testing evaluated chemical composition (XRD, Ca:P ratio), physical properties (density, volume, porosity, pore diameter, interconnectedness), pH, and in vitro dissolution rates. Animal testing was conducted to evaluate bone in-growth and resorption over time.

Technological Characteristics

Material: beta-Tricalcium Phosphate (B-TCP). Form: Granules (1-4 mm). Porosity: ~80% with multidirectional interconnected structure. Chemical/Physical: Ca:P ratio, XRD phase analysis, bulk density, and dissolution rate. Sterilization: Provided sterile. Connectivity: N/A. Energy source: N/A.

Indications for Use

Indicated for filling bony voids or gaps in extremities, posterolateral spine, and pelvis caused by trauma or surgery; not for use where structural stability is required.

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

• CAMCERAM TCP (K050357)

Submission Summary (Full Text)

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# Chapter 5 510(k) Summary [per 21 CFR 807.92(c)]

r

| 5. 510(k) Summary as required by section 807.92(c) | | | DEC 27 2010 |
|-------------------------------------------------------------------------------------------------|-------------------------------|--------------------------------|-------------|
| 5.1. FDA Contact Person | | 5.3. 510(k) Preparer/submitter | |
| Victor Bowers | | Victor Bowers | |
| VP Medical Affairs | | VP Medical Affairs | |
| Phone [phone]<br>Cell [phone]<br>Fax [phone]<br>Email [e-mail] | | Cytophil, Inc. | |
| 5.2. 510(k) Owner | | 2485 Corporate Circle, Suite 2 | |
| William G. Hubbard Ph.D. | | East Troy, WI 53120 | |
| President & CEO | | Phone [phone] | |
| Cytophil, Inc. | | Cell [phone] | |
| 2485 Corporate Circle, Suite 2 | | Fax [phone] | |
| East Troy, WI 53120 | | Email [e-mail] | |
| Phone [phone] | | | |
| Cell [phone] | | | |
| Fax [phone] | | | |
| Email [e-mail] | | | |
| [807.92(a)(1)] | | | |
| 5.4. Device Name[per 807.92(a)(2)] | | | |
| Trade (proprietary) name : | Osteophil B-TCP | | |
| Common name: | Synthetic Bone Graft Material | | |

Resorbable Calcium Salt Bone Void Filler Classification name:

5.5. Legally Marketed device to which your firm is claiming equivalence [807.92(a)(3)]

f

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| Equivalent legally marketed Device title | 510(k) number |
|------------------------------------------|---------------|
| CAMCERAM TCP | K050357 |

5.6. Description of the device [807.92(a)(4)]

Osteophil B-TCP is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. The product consists of beta-Tricalcium Phosphate and is about 80% porous. The product is provided sterile and is available in granules 1-4 mm².

Osteophil B-TCP has a multidirectional interconnected porosity structure, similar to that of human cancellous bone. Osteophil B-TCP slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption of Osteophil B-TCP resorbable bone filler is intended to prevent premature resorption.

### 5.7. Intended use of the device [807.92(a)(5)]

Osteophil B-TCP is a resorbable bone void filler intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

This intended use of the device is identical to and, therefore, equivalent to predicate K050357 -CAMCERAM TCP.

## 5.8. Summary of the technological characteristics of your device compared to the predicate device. [807.92(a)(6)]

Osteophil B-TCP has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device, K050357 - CAMCERAM TCP. Following is a summary of the technological characteristics of Osteophil B-TCP in comparison to those of the predicate device, K050357 - CAMCERAM TCP.

| Characteristic | Substantially Equivalent? | Impact on Safety & Performance |
|-----------------------------------|---------------------------|--------------------------------|
| Device | | |
| Design | YES | None |
| Material Characterization | YES | None |
| Biocompatibility | YES | None |
| Sterilization | YES | None |
| Physical Properties | | |
| Identification of Device Material | YES | None |
| Additives | NA | NA |
| Ca/Phosphorus Ratio | YES | None |

² 1-4 mm equals 1000 – 4000 um

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| Elemental Analysis | YES | None |
|-------------------------------|-----|------|
| X-Ray Diffraction Patterns | YES | None |
| Dimensional Specifications | YES | None |
| Physical Form of the Device | YES | None |
| Device Density | YES | None |
| Device Mass | YES | None |
| Device Volume | YES | None |
| Device Porosity | | |
| • Total Porous Volume | YES | None |
| • Pore Diameter | YES | None |
| • Interconnectedness | YES | None |
| pH Testing | YES | None |
| Dissolution Testing (mg/L/hr) | YES | None |
| Energy Source | NA | NA |

Osteophil B-TCP has substantially equivalent critical specifications as CAMCERAM TCP -K050357.

Osteophil B-TCP has substantially equivalent technical characteristics as the predicate K050357 -CAMCERAM TCP. The chemical and physical characteristics are compared in section 11.2. These characteristics include the following:

- . Chemical Composition by XRD spectra
- o Phases present
- o Ca:P ratio
- . Physical Properties
- o Physical Form
- Dimensional Specifications o
- Porosity o
- Bulk density o
- . Performance Testing
- o pH
- o In vitro dissolution rate
- Animal testing to determine bone in-growth and resorption of the implant over o time

The characteristics were evaluated by performing testing using standardized laboratory test methods. The test results demonstrate the substantial equivalence of the technical characteristics of Osteophil B-TCP to the predicate.

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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & S" is arranged vertically along the left side of the logo.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Cytophil, Inc. % Victor M. Bowers 2485 Corporate Circle, Suite 2 East Troy. WI 53120

DEC 2 7 2010

Re: K102937

Trade/Device Name: Osteophil B-TCP Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: September 28, 2010 Received: October 4, 2010

Dear Mr. Bowers:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutlTDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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.

Neil Ogden for

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 4. Indication for Use Statement

DEC 2 7 2010

4.1. 510(k) Number

(If known): K 102937

4.2. Device Name

Osteophil B-TCP

4.3. Indications for Use

Osteophil B-TCP is a resorbable bone void filler intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X or Over-the-Counter Use _ [Per 21 CFR 801.109]

Nilk & Oyler
(Division Sign-Off)
for mxm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102937