INQU

K063359 · Isto Technologies, Inc. · MQV · Apr 16, 2007 · Orthopedic

Device Facts

• Record ID: K063359
• Device Name: INQU
• Applicant: Isto Technologies, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Apr 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

InQu™ is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQuTM is intended to be gently packed into bony gaps or voids in the skeletal system (extremities and pelvis). These defects may be surgically created or result from traumatic injury to the bone.

Device Story

InQu™ is a sterile, granular, synthetic bone void filler; composed of poly (D, L-lactide-co-glycolide) and hyaluronic acid. Device is intended for single patient use; packed manually by surgeons into non-structural bony defects in extremities and pelvis. Material resorbs over time, replaced by natural bone during healing process. Intended to facilitate bone repair in surgically created or traumatic defects.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by biocompatibility testing and animal model performance data.

Technological Characteristics

Sterile, granular, synthetic bone void filler. Composition: poly (D, L-lactide-co-glycolide) and hyaluronic acid. Resorbable. Single patient use.

Indications for Use

Indicated for patients with bony gaps or voids in the skeletal system (extremities and pelvis) that are not intrinsic to the stability of the bony structure, resulting from surgical creation or traumatic injury.

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

• PolyGraft™ BGS, OsteoBiologics, Inc., K040047

Submission Summary (Full Text)

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Submitter:
ISTO Technologies, Inc.

...

K063359
InQu™

InQu™ InQu™
Traditional 510(k)

## Section 5.0 510(k) Summary

| Submitter Name: | ISTO Technologies, Inc. | APR 16 2007 |
|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitter Address: | 1155 Olivette Executive Parkway, Suite 200<br>St. Louis, Missouri 63132 | |
| Contact Person: | Gary Gage<br>Program Director | |
| Phone Number: | 314-995-6049 | |
| Fax Number: | 314-995-6025 | |
| Date Prepared: | November 3, 2006 | |
| Device Trade Name: | InQu™ | |
| Device Common Name: | Resorbable bone void filler | |
| Classification Name: | Filler, bone void, calcium salt compound | |
| Classification Number: | 21 CFR 888.3045 | |
| Product Code: | MQV | |
| Predicate Devices: | PolyGraft™ BGS, OsteoBiologics, Inc., K040047 | |
| Statement of<br>Intended Use: | InQu™ is a resorbable bone void filler intended to fill bony gaps or<br>voids that are not intrinsic to the stability of the bony structure.<br>InQuTM is intended to be gently packed into bony gaps or voids in the<br>skeletal system (extremities and pelvis). These defects may be<br>surgically created or result from traumatic injury to the bone. | |
| Device Description,<br>Summary of<br>Technological<br>Characteristics, and<br>Comparison to the<br>Predicate Device | InQu™ is intended for single patient use only. InQu™ is a sterile,<br>granular, synthetic bone void filler device composed of poly (D, L-<br>lactide-co-glycolide) and hyaluronic acid. It resorbs and is replaced<br>with bone during the healing process. Testing has confirmed InQu™<br>is biocompatible as a bone void filler device. InQu™ is substantially<br>equivalent to the predicate device in terms of material composition.<br>technological characteristics and bone healing performance in an<br>animal model. | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ISTO Technologies c/o Ms. Patsy J. Trisler, J.D., RAC 5600 Wisconsin Ave. #૨૦તે Chevy Chase, MD 20815

APR 1 6 2007

Re: K063359

Trade Name: InQuTM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MOV Dated: January 29 2007 Received: January 30, 2007

Dear Ms. Trisler:

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 – Ms. Pastsy J. Trisler

You must comply with all the Act's requirements, including, but not limited to: registration r od intilet compy + + + + 807); labeling (21 CFR Part 801); good manufacturing practice and ifsing (21 CF Far are of 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), 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/industry/support/index.html.

Sincerely yours,

Barbace Buent

Mark N. Melkerson. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K063359

510(k) Number (if known):

Device Name:

InQu™

## Indications for Use:

InQu™ is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu™ is intended to be gently packed into bony gaps or voids in the skeletal system (extremities and pelvis). These defects may be surgically created or result from traumatic injury to the bone.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

(Posted November 13, 2003)

barbare buem

Division of General. Restorative, and Neurological Devices

**510(k) Number** K063359