MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER

K011726 · Millenium Biologix, Inc. · MQV · May 16, 2002 · Orthopedic

Device Facts

• Record ID: K011726
• Device Name: MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER
• Applicant: Millenium Biologix, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: May 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Skellite™ Synthetic Resorbable Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Skelite™ is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. The product can be mixed with bone marrow.

Device Story

Skelite™ is a synthetic, resorbable bone void filler; intended for filling non-structural osseous defects in extremities, spine, and pelvis. Device is packed into voids by surgeons; may be mixed with autologous bone marrow prior to application. Material resorbs over time, facilitating replacement with natural bone during healing. Used in clinical/surgical settings to manage bone gaps resulting from trauma or surgical procedures.

Technological Characteristics

Synthetic, resorbable bone void filler material. Designed for manual packing into osseous defects. Compatible with mixing with bone marrow.

Indications for Use

Indicated for patients with non-structural bony voids or gaps in the extremities, spine, or pelvis caused by surgery or trauma. Contraindicated for use in areas where structural stability of the bone is required.

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)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

MAY 1 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Robert Schiff, Ph.D., RAC, COA (ASQC) President Schiff & Company for Millenium Biologix, Inc. 1129 Bloomfield Avenue West Caldwell, New Jersey 07006

Re: K011726

Trade Name: SKELITE™ Synthetic Resorbable Bone Void Filler Regulatory Class: Unclassified Product Code: MQV Dated: February 22, 2002 Received: February 25, 2002

Dear Dr. Schiff:

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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## Page 2 - Robert Schiff, Ph.D., RAC, CQA (ASQC)

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 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,

Miriam C. Provost

for 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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## INDICATIONS FOR USE

The Skellite™ Synthetic Resorbable Bone Void Filler is indicated only for bony voids on I he Skence - Bynthone reability of the bony structure. Skelite "" is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, be gently paokid into belly veats may be surgically created osseous defects or osseous spine, and pervisy. Theose coloring to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. The product can be mixed with bone marrow.

Miriam C. Provost

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

510(k) Number K011726