CALLOS IMPACT AND INJECT BONE VOID FILLER

K051123 · Skeletal Kinetics, LLC · MQV · Jun 3, 2005 · Orthopedic

Device Facts

• Record ID: K051123
• Device Name: CALLOS IMPACT AND INJECT BONE VOID FILLER
• Applicant: Skeletal Kinetics, LLC
• Product Code: MQV · Orthopedic
• Decision Date: Jun 3, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Callos 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.

Device Story

Callos is a calcium phosphate bone void filler; used to fill non-structural bony voids or gaps in the skeletal system. Product is single-use; applied via injection or digital impaction into the defect site by a surgeon. Material resorbs over time and is replaced by natural bone during the healing process. Device is intended for use in clinical settings for orthopedic or trauma-related bone repair.

Clinical Evidence

No clinical data provided; substantial equivalence based on material modification and bench testing.

Technological Characteristics

Calcium phosphate-based bone void filler. Resorbable material. Single-use. Sterilized.

Indications for Use

Indicated for patients with surgically created or traumatic osseous defects in the skeletal system (extremities, spine, pelvis) that are not intrinsic to bony structure stability.

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

• Callos Bone Void Filler (K030554)

Submission Summary (Full Text)

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K051123

### JUN 3 - 2005

## 510(k) Summary

# Skeletal Kinetics, LLC Callos™ Bone Void Filler

General Information

| Submitters Name/Address: | Skeletal Kinetics 10201 Bubb Road Cupertino, CA 95014 |
|------------------------------------|----------------------------------------------------------------------------|
| Establishment Registration Number: | 3003890476 |
| Contact Person: | Duran Yetkinler Vice President, Product Development and Regulatory Affairs |
| Phone Number: | [phone] |
| Date Prepared: | April 28, 2005 |

Device Description

| Trade Name: | Callos™ Bone Void Filler |
|----------------------|--------------------------|
| Generic/Common Name: | Bone Void Filler |
| Classification Name: | 87 MVQ |

Predicate Devices

| Callos Bone Void Filler | K030554; cleared on May 20, 2003 |
|-------------------------|----------------------------------|
|-------------------------|----------------------------------|

#### Product Description

Callos is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.

#### Intended Use

Callos 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.

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K051123

#### Substantial Equivalence

This Special 510(k) proposes a modification in materials for Callos, which was previously cleared under K030554 on May 20, 2003. The indications for use, technology, principle of operation, packaging, and sterilization parameters of Callos remain the same as in the predicate cleared 510(k)s.

### Summary of Safety and Effectiveness

Callos, as described in this submission, is substantially equivalent to the predicate, unmodified Callos. The proposed modification in materials, is not a substantial change or modification, and does not significantly affect the safety or efficacy of Callos.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 - 2005

Duran Yetkinler, M.D., Ph.D. Vice President, Product Development and Regulatory Affairs Skeletal Kinetics, LLC 10201 Bubb Road Cupertino, CA 95014

Re: K051123

Callos Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: April 28, 2005 Received: May 3, 2005

Dear Dr. Yetkinler:

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.

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### Page 2 - Duran Yetkinler, M.D., Ph.D.

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.

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), n you acontact 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/industry/support/index.html.

Sincerely yours,

Miriam C. Provost

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

KORII23 510(k) Number (if known):

Callos™ Bone Void Filler Device Name:

Indications for Use:

Callos 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.

X AND/OR Over-the-Counter Use Prescription Use (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number K051123