CALLOS

K030554 · Skeletal Kinetics, LLC · MQV · May 20, 2003 · Orthopedic

Device Facts

• Record ID: K030554
• Device Name: CALLOS
• Applicant: Skeletal Kinetics, LLC
• Product Code: MQV · Orthopedic
• Decision Date: May 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Callos Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Device Story

Callos Bone Void Filler is an injectable, moldable, biocompatible, resorbable calcium phosphate-based material. Supplied in 3 cc, 5 cc, and 10 cc sterile, single-use kits. Used by surgeons to fill non-structural bony voids or gaps in the extremities, spine, or pelvis. Material resorbs in vivo and is replaced by natural bone during the healing process. Clinical benefit is the restoration of bone volume in non-load-bearing defects.

Clinical Evidence

No human clinical data. Evidence consists of non-clinical bench testing (density, porosity, dimensional stability, injectability, setting time/temperature, pH) and biocompatibility testing (non-cytotoxic, non-mutagenic, non-pyrogenic). Comparative analysis with predicate included XRD, FTIR, and elemental analysis. Animal testing confirmed substantial equivalence via histological, chemical, crystallographical, and mechanical analyses.

Technological Characteristics

Injectable, moldable, resorbable calcium phosphate-based bone void filler. Sterile, single-use. Properties include specific density, porosity, and setting characteristics. No electronic or software components.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) resulting from surgery or traumatic injury. Contraindicated for voids or gaps intrinsic to the stability of the bony structure.

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

• Norian SRS Bone Void Filler (K011897)

Submission Summary (Full Text)

{0}------------------------------------------------

K0305541

## MAY 2 0 2003

## 510(k) Summary

| Sponsor: | Skeletal Kinetics, LLC<br>10201 Bubb Road, Cupertino, CA 95014 |
|-----------------|----------------------------------------------------------------|
| Contact Person: | Duran Yetkinler, M.D., Ph.D. |
| Phone Number: | 408 366 5002 |
| Fax Number: | 408 366 1077 |
| Prepared: | February 18, 2003 |

Trade Name: Callos™M Bone Graft Substitute Common Name: Classification: Unclassified Product Code: 87 MVQ

Predicate Device: Callos Bone Void Filler is substantially equivalent to Norian SRS Bone Void Filler (K011897).

Device Description: Callos Bone Void Filler is an injectable, moldable and biocompatible bone void filler. Callos Bone Void Filler resorbs and is replaced with bone during the healing process. The 3 cc, 5 cc, and 10 cc Callos Bone Void Filler kits are provided sterile and are for single use only.

Intended Use/Indications for Use: Callos Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Technological Characteristics: Similar to the predicate device. Callos Bone Void Filler is an injectable, moldable, biocompatible, resorbable calcium phosphate based material intended for identical indications.

Performance Data: Non-clinical testing included material properties such as density, porosity, dimensional stability, injectability, setting time, working time, pH, and setting temperature. Biocompatibility testing demonstrated that the material is non-cytotoxic, non-systemic toxic, non-mutagenic, non-irritative, non-pyrogenic, and non-sensitizing. Comparative testing with the predicate device showed equivalence in terms of solubility and dissolution rate, X-Ray Diffraction (XRD), Fourier Transform Infrared (FTIR) spectroscopy and elemental analysis. Animal testing demonstrated substantial equivalence to the predicate device following in vivo implantation. Histological, chemical, crystallographical, and mechanical analyses showed substantial equivalence.

Basis for Substantial Equivalence: The Callos Bone Void Filler has the same intended use, identical indications, and very similar technological characteristics as the predicate device. Any minor technological differences between Callos Bone Void Filler and its predicate device do not raise any new issues of safety or effectiveness.

Skeletal Kinetics, LLC - Confidential

page 1 of 2 Appendix C

{1}------------------------------------------------

Functional, biocompatibility, and animal testing results show that the Callos Bone Void Filler is as safe and effective as the predicate device. Thus, the Callos Bone Void Filler is substantially equivalent.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2003

Skeletal Kinetics, LLC c/o Mr. Howard Holstein Regulatory Counsel Hogan & Hartson, LLC 555 13th Street, N.W. Washington, DC 20004

Re: K030554

Trade/Device Name: Callos™ Bone Void Filler Regulatory Class: Unclassified Product Code: MQV Dated: February 20, 2003 Received: February 21, 2003

Dear Mr. Holstein:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

{3}------------------------------------------------

Page 2 - Mr. Howard Holstein

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N. Milkman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## 510(k) Indications for Use

510(k) Number (if known):

Device Name:

Callos Bone Void Filler

403055

Page

of

Indications for use:

Callos Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

OR

Over-the-Counter Use

(Division Sign-Off)
Division of General, Restorative and
Neurological Devices

510(k) Number K030554