QUICKSET MIMIX BONE VOID FILLER

K023718 · Walter Lorenz Surgical, Inc. · GXP · Dec 4, 2002 · Neurology

Device Facts

• Record ID: K023718
• Device Name: QUICKSET MIMIX BONE VOID FILLER
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: GXP · Neurology
• Decision Date: Dec 4, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The QuickSet Mimix™ Bone Void Filler is a self-setting calcium phosphate cement indicated for the following craniofacial procedures: 1. Repair of neurosurgical burr holes 2. Craniotomy cuts and other cranial defects 3. Augmentation or restoration of bony contour in the craniofacial skeleton area no larger that 25 cm²

Device Story

QuickSet Mimix™ is a self-setting calcium phosphate bone void filler. Packaged as separate, pre-measured powder (ceramic calcium phosphate and sodium citrate dihydrate) and liquid (anhydrous citric acid and distilled water) components. Components mixed intraoperatively to form a homogenous paste; applied to bone gaps or defects. Apatitic nature provides biocompatibility. Used in craniofacial procedures to fill voids or restore contour. Intended for prescription use.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical testing demonstrating statistical equivalence to the predicate device.

Technological Characteristics

Self-setting calcium phosphate cement. Powder component: ceramic calcium phosphate, sodium citrate dihydrate. Liquid component: anhydrous citric acid, distilled water. Apatitic material. Form factor: intraoperatively mixed paste.

Indications for Use

Indicated for patients requiring repair of neurosurgical burr holes, craniotomy cuts, other cranial defects, or augmentation/restoration of craniofacial bony contour (area ≤ 25 cm²).

Regulatory Classification

Identification

Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

Predicate Devices

• Mimix™ Bone Void Filler (K990290)

Submission Summary (Full Text)

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10237/8
DEC 04 2002

### SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant or Sponsor: | Walter Lorenz Surgical, Inc<br>(A wholly owned subsidiary of Biomet, Inc.)<br>1520 Tradeport Drive<br>P.O. Box 18009<br>Jacksonville, FL 32229-8009<br>Establishment Registration Number: 1032347 |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kacy Arnold, RN, MBA<br>Telephone: [phone]<br>Fax: [phone] |
| Proprietary Name: | QuickSet Mimix™ Bone Void Filler |
| Common or Usual Name: | Calcium Phosphate Cement |
| Device Classification: | Implant, endosseous for bone filling and/or<br>reconstruction (872.3640) |
| Device Product Code: | 84GXP |
| Legally Marketed Devices<br>To Which Substantial<br>Equivalence Is Claimed: | Mimix™ Bone Void Filler (K990290) |

### Indicated Use:

The QuickSet Mimix™ Bone Void Filler is a self-setting calcium phosphate cement indicated for the following craniofacial procedures:

- 1. Repair of neurosurgical burr holes
- 2. Craniotomy cuts and other cranial defects
- 3. Augmentation or restoration of bony contour in the craniofacial skeleton area no larger that 25 cm²

Device Description: The QuickSet Mimix™ is packaged as separate, pre-measured powder and liquid components. The two components are designed to be mixed intraoperatively to produce a homogenous paste, which can then be applied to bone gaps or defects. Because of its apatitic nature, the material is highly biocompatible.

The powder component is a mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate (Na3GHzO7+2H2O). The liquid component is a solution comprised of anhydrous citric acid (CGHsO7) and distilled water (H3O).

Non-Clinical Testing: Non-clinical testing demonstrated statistical equivalence between this device and the predicate device.

| Clinical Testing: Clinical testing was not used to establish substantial equivalence. | | | |
|---------------------------------------------------------------------------------------|---------------------|-----------------------------|--|
| MAILING ADDRESS | | SHIPPING ADDRESS | |
| P.O. Box 587 | | 56 E. Bell Drive | |
| Warsaw, IN 46581-0587 | | Warsaw, IN 46582 | |
| OFFICE<br>Mimix is a trademark of Biomet, Inc | FAX<br>574.267.8137 | E-MAIL<br>[e-mail] | |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kacv Arnold, RN, MBA Regulator Affairs Specialist Biomet Manufacturing, Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587

Re: K023718

> Trade Name: QuickSet Mimix™ Bone Void Filler Regulation Number: 882.5300 Regulation Name: Methyl Methacrylate for Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: October 31, 2002 Received: November 5, 2002

Dear Ms. Arnold:

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 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). 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 111 (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. You must comply with all the Act's requirements, including, but not limited to: registration

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Page 2 - Ms. Kacy Arnold

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 legallypredicate 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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

sincerely yours,

U Mark N. Melberras

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

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510 (k) Number (if known) : K023718

Device Name: QuickSet Mimix™ Bone Void Filler

# Indications for Use:

The QuickSet Mimix™ Bone Void Filler is a self-setting calcium phosphate cement indicated for the following craniofacial procedures:

- 1. Repair of neurosurgical burr holes
- Craniotomy cuts and other cranial defects 2.
- Augmentation or restoration of bony contour in the craniofacial skeleton area no larger 3. that 25 cm²

Márk N. Millenson

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

510(k) Number K0237

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# 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)