STIMULAN KIT, STIMULAN RAPID CURE

K141830 · Biocomposites, Ltd. · MQV · Jan 23, 2015 · Orthopedic

Device Facts

• Record ID: K141830
• Device Name: STIMULAN KIT, STIMULAN RAPID CURE
• Applicant: Biocomposites, Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: Jan 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stimulan Kit/Stimulan Rapid Cure is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created from traumatic injury to the bone. Stimulan Kit/Stimulan Rapid Cure is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, and posterolateral spine). Stimulan Kit/Stimulan Rapid Cure provides a bone graft substitute that resorbs and is replaced with bone during the healing process. Stimulan Kit/Stimulan Rapid Cure is biodegradable and biocompatible and may be used at an infected site. To fill a bone void or defect created by: surgery, a cyst, a tumour, osteomyelitis, traumatic injury

Device Story

Bone void filler; consists of medical grade calcium sulfate powder and mixing solution. Mixed to form paste; applied via injection, digital implantation, or molded into pellets. Used by surgeons in clinical settings to fill non-structural osseous defects; resorbs and is replaced by bone during healing. Biocompatible; suitable for use at infected sites. Provides structural support for healing process; benefits patient by facilitating bone regeneration in voids.

Clinical Evidence

No clinical data; bench testing only. Labeling modifications do not affect safety or effectiveness.

Technological Characteristics

Medical grade calcium sulfate; biodegradable; biocompatible. Form factor: powder and mixing solution for paste or pellet preparation. Resorbable bone graft substitute.

Indications for Use

Indicated for patients requiring bone void filling in non-structural skeletal defects (extremities, pelvis, posterolateral spine) caused by surgery, cysts, tumors, osteomyelitis, or trauma. May be used 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

• Stimulan Kit (K021551)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 23, 2015

Biocomposites Ltd Mr. Simon Fitzer Keele Science Park Keele Staffordshire ST5 SNL United Kingdom

Re: K141830

Trade/Device Name: Stimulan Kit/Stimulan Rapid Cure Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: December 22, 2014 Received: December 24, 2014

Dear Mr. Fitzer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 – Mr. Simon Fitzer

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141830

## Device Name

Stimulan Kit/Stimulan Rapid Cure

### Indications for Use (Describe)

Stimulan Kit/Stimulan Rapid Cure is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created from traumatic injury to the bone. Stimulan Kit/Stimulan Rapid Cure is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, and posterolateral spine). Stimulan Rapid Cure provides a bone graft substitute that resorbs and is replaced with bone during the healing process. Stimulan Rapid Cure is biodegradable and biocompatible and may be used at an infected site.

To fill a bone void or defect created by:

- . surgery
- . a cyst
- a tumour .
- . osteomyelitis
- . traumatic injury

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY . . . . . . . . . . . . . . . . .

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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## 510(k) Summary

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR807.92(c), the following information serves as a Summary of Safety and Effectiveness for the use of Stimulan Kit/Stimulan Rapid Cure.

| 1. | Submitted by: | Biocomposites Ltd<br>Keele Science Park<br>Keele<br>Staffordshire<br>ST5 5NL<br>England |
|----|-------------------|-----------------------------------------------------------------------------------------|
| | Date: | January 23, 2015 |
| | Contact Person: | Simon Fitzer<br>Regulatory<br>Tel: [phone]<br>Fax: [phone] |
| 2. | Proprietary Name: | Stimulan Kit/Stimulan Rapid Cure |
| | Common Name: | Bone Void Filler |

21 CFR 888.3045 – Class II Classification:

Product Code/Panel: MQV/Orthopedic

- 3. Pimary Predicate Device: K021551- Stimulan Kit

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#### 4. Device Description

Stimulan Kit/Stimulan Rapid Cure are indicated to be implanted into defects not intrinsic to the structural stability of the skeletal system. Stimulan Kit/Stimulan Rapid Cure are biocompatible and may be implanted at an infected site. Stimulan Kit/Stimulan Rapid Cure are presented as a powder and mixing solution which when mixed together form a paste which may be injected, digitally implanted or applied to the mold provided to produce pellets.

#### 5. Materials

Stimulan Kit/Stimulan Rapid Cure are manufactured from medical grade calcium sulfate. Stimulan Kit/Stimulan Rapid Cure resorbs and is replaced by bone during the healing process.

#### 6. Intended Use

Stimulan Kit/Stimulan Rapid Cure is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created from traumatic injury to the bone. Stimulan Kit/Stimulan Rapid Cure is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, and posterolateral spine). Stimulan Kit/Stimulan Rapid Cure provides a bone graft substitute that resorbs and is replaced with bone during the healing Stimulan Kit/Stimulan Rapid Cure is biodegradable and process. biocompatible and may be used at an infected site.

To fill a bone void or defect created by:

- surgery •
- . a cyst
- a tumour
- . osteomyelitis
- . traumatic injury

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## 7. Technological Characteristics Comparison

The technological characteristics have not changed as a result of the labeling modification.

#### 8. Substantial Equivalence - Non - Clinical Evidence

Design controls were implemented following risk analysis. No new risks were identified demonstrating that the modified device is substantially equivalent to the predicate device.

#### Substantial Equivalence - Clinical Evidence 9.

Clinical performance data was not required as the labelling modifications do not affect the safety and effectiveness of the modified device.

## 10. Substantial Equivalence - Conclusions

The labeling modifications made do not raise any new concerns regarding safety and effectiveness. The information provided supports that the modified Stimulan Kit/Stimulan Rapid Cure is substantially equivalent to the predicate device.