STIMULAN- CALCIUM SULFATE BONE VOID FILLER

K982663 · Encore Orthopedics, Inc. · MQV · Feb 26, 1999 · Orthopedic

Device Facts

• Record ID: K982663
• Device Name: STIMULAN- CALCIUM SULFATE BONE VOID FILLER
• Applicant: Encore Orthopedics, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Feb 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stimulan™ is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes may be undesirable, due either to the risk of associated infection or unavailability. Stimulan™ is manufactured from medical grade calcium sulfate that resorbs and is replaced with bone during the healing process. Also, as the implant is biodegradable and biocompatible, it may be used at an infected site.

Device Story

Stimulan™ is a bone void filler provided as sterile, biodegradable, radiopaque calcium sulfate pellets. Used in clinical settings to fill bone voids where autologous graft is unavailable or infection risk exists. Implant resorbs over 30-60 days and is replaced by natural bone during healing. Biocompatible nature allows use at infected sites. Physician-operated; provides structural void filling to support bone regeneration.

Clinical Evidence

Bench testing only. Testing demonstrated equivalent dissolution, mechanical, and mass-to-volume ratio characteristics to predicate devices. Product confirmed non-pyrogenic.

Technological Characteristics

Composition: 98% medical grade calcium sulfate dihydrate (CaSO4·2H2O) and stearic acid. Form factor: Pellets. Sterilization: Provided sterile. Biodegradable and radiopaque.

Indications for Use

Indicated for clinical situations where autologous bone grafts or other substitutes are undesirable due to infection risk or unavailability; suitable for use at infected sites.

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

• Wright Medical - Osteoset Pellets
• BioGeneration - ProFusion Bone Graft Substitute

Submission Summary (Full Text)

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2/26/99

K 982663

### 510(k) Summary

Encore Orthopedics, Inc. Submitter's Name: 9800 Metric Blvd., Austin, TX 78758 Submitter's Address: Submitter's Telephone Number: [phone] Debbie De Los Santos Contact Person: July 30, 1998 Submission Date: Stimulan™ Calcium Sulfate Bone Void Filler Trade Name: Calcium Sulfate Common Name: Unknown Classification Name: Wright Medical - Osteoset Pellets Legally Marketed Predicate Device: BioGeneration - ProFusion Bone Graft Substitute

#### Device Description:

Stimulan™ Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 pans when used in accordance with the device labeling. Stimulan™ is manufactured from 98% medical grade calcium sulfate dihydrate (CaSO4 - 2H2O) and stearic acid.

## Indications For Use:

Stimulan™ is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes may be undesirable, due either to the risk of associated infection or unavailability. Stimulan™ is manufactured from medical grade calcium sulfate that resorbs and is replaced with bone during the healing process. Also, as the implant is biodegradable and biocompatible, it may be used at an infected site.

## Technological Characteristics:

Stimulan™ has the equivalent technological characteristics (i.e. chemical composition, and dissolution rate performance as the predicate device.

#### Performance Date:

Testing demonstrated that Stimulan™ has equivalent dissolution, mechanical and mass to volume ratio characteristics to the predicate device. Testing indicated that the product is non-pyrogenic.

## Basis for Substantial Equivalence:

Stimulan™ is safe and effective because it is equivalent to the predicate device in terms of chemical composition, indication of use, and product performances.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 1999

Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758

K982663 Re : Stimulan™ - Calcium Sulfate Bone Void Filler Trade Name: Unclassified Regulatory Class: MOV Product Code: January 29, 1999 Dated: February 5, 1999 Received:

Dear Ms. De Los Santos:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been realour bood in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major be Babyers affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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## Page 2 - Ms. Debbie De Los Santos

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in jour can equivalence of your device to a legally rinang or edicate device results in a classification for your marketca produces of mits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact che promotion and Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

## Stimulan™

## Indications For Use

Stimulan™ is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes may be undesirable, due either to the risk of associated infection or unavailability. Stimular™ is manufactured from medical grade calcium sulfate that resorbs and is replaced with bone during the healing process. Also, as the implant is biodegradable and biocompatible, it may be used at an infected site.

# (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 _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)_

bracello

(Divisio Divisior 510kl Nr