STIMULAN -CALCIUM SULFATE BONE VOID FILTER

K001724 · Biocomposites, Ltd. · MQV · Aug 4, 2000 · Orthopedic

Device Facts

• Record ID: K001724
• Device Name: STIMULAN -CALCIUM SULFATE BONE VOID FILTER
• Applicant: Biocomposites, Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: Aug 4, 2000
• 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 sterile, biodegradable, radiopaque calcium sulfate bone void filler provided as pellets. It is used as a bone graft substitute in clinical settings where autologous grafts are unavailable or carry infection risks. The device is biocompatible and can be placed at infected sites. Upon implantation, the calcium sulfate resorbs over approximately 30-60 days and is replaced by natural bone during the healing process. It is intended for use by clinicians.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Composition: 98% medical grade calcium sulfate dihydrate (CaSO4 · 2H2O) and stearic acid. Form factor: Pellets. Resorption time: 30-60 days. Sterilization: Sterile.

Indications for Use

Indicated for patients requiring bone graft substitutes in clinical situations where autologous grafts 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.

Submission Summary (Full Text)

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

#### AUG 4 2000

# Summary of Safety and Effectiveness

Koo/24

Biocomposites Ltd Etruscan Street Etruria Stoke-on-Trent ST1 SPO England 44 01782 206500

Trade Name: Stimulan™ Calcium Sulfate Bone Void Filler

Common Name: Calcium Sulfate

Classification Name: Unknown

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

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 biodegrable and biocompatible, it may be used at an infected site.

Comparable Features to Predicate Device(s): Features comparable to predicate devices include equivalent design, materials and indications.

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

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### AUG 4 2000

Mr. J Stephen Bratt Managing Director Biocomposites Ltd. Etruscan Street, Ethuria, Stoke-on-Trent Staffordshire, ST1 5PQ, England

Re: K001724

Trade Name: Stimulan Calcium Sulfate Pellets Regulatory Class: Unclassified Product Code: MQV Dated: May 22, 2000 Received: May 26, 2000

## Dear Mr. Bratt:

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 legally marketed predicate devices marketed in interstate commerce stired in the energence, to 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). You may, therefore, market the device, subject to the general control Coonisions of the Act. The general control provisions of the Act include requirements for annual provisions of ani-1994 - 1997 - 1997 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 regulations (Fremances I pprovide in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 mopolwaiith the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations.

This letter will allow you to begin marketing your device as described in your 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.

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

# Page 2 - Mr. J Stephen Bratt

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 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Dmne R. lochner

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

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

# 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. 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.

e R. bochner.

(Division Sign-Off) Division of General Restorative Devices K001724 510(k) Number