MARROW PLUS (M+)

K051695 · Berkeley Advanced Biomaterials, Inc. · MQV · Jul 19, 2005 · Orthopedic

Device Facts

• Record ID: K051695
• Device Name: MARROW PLUS (M+)
• Applicant: Berkeley Advanced Biomaterials, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Jul 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2

Intended Use

Marrow Plus (M+™) is intended for use as a system for the aspiration of bone marrow, autologous blood, plasma or other blood components. Prior to use, the syringe is either pre-filled or filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). This system provides the surgeon with a convenient way to mix and deliver the material to the orthopaedic surgical site. M+ may be pre-filled with synthetic bone substitute (Bi-Ostetic, Cem-Osetic, Tri-Ostetic, BioPlus, GenerOs) shaped as granules or blocks (cancellous, cortical or cortico-cancellous) to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules or blocks provide void filling material that acts as a temporary support medium. The material is radio-opaque. It is biocompatible and resorbs in the body as bone ingrowth occurs.

Device Story

M+ is a piston syringe system designed for orthopaedic surgical use. It functions as a delivery vehicle for bone marrow aspirate, blood components, or bone void fillers (granules/blocks). The surgeon fills the syringe with the desired graft material or aspirate and manually injects the contents into non-structural bone voids in the extremities, spine, pelvis, or cranium. The device facilitates mixing and precise delivery of graft materials to the surgical site. It acts as a temporary support medium while the biocompatible, radio-opaque filler resorbs during natural bone ingrowth. The device is intended for use by surgeons in an operating room setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Piston syringe system; manual operation; biocompatible, radio-opaque materials; designed for delivery of bone graft substitutes (granules/blocks).

Indications for Use

Indicated for use as a system for bone marrow, autologous blood, or plasma aspiration and for the delivery of bone void fillers (allograft, autograft, or synthetic) to fill non-structural bony voids or gaps in the extremities, spine, pelvis, or cranium.

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.

Reference Devices

• Bi-Ostetic
• Cem-Osetic
• Tri-Ostetic
• BioPlus
• GenerOs

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

JUL 19 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Francois Génin, Ph.D. Chief Executive Officer Berkeley Advanced Biomaterials, Inc. . 901 Grayson Street, Suite 101 Berkeley, California 94710

Re: K051695 Trade/Device Name: M+ Regulation Number: 21 CFR 888.3045, 21 CFR 880.5860 Regulation Name: Resorbable calcium salt bone void filler device, Piston syringe Regulatory Class: II Product Code: FMF, MQV Dated: June 14, 2005 Received: June 23, 2005

Dear Dr. Génin:

We have reviewed your Section 510(k) premarket notification of intent to market the device w that teviewed your becarence the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease of the enactment date of the Medical Device Amendments, or to conniner of the 114) 20, 2017 () 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 r ou may, mererere, mains 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 If your device is exassined 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 r read on as 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 or any I 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 Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quarty by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Francois Génin, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yours of substantial equivalence of your device to a legally prematics notification "Theselve 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), please If you desire of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Journer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Eric A. Olson

Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number: K051695

Device Name: M+

Indications for Use:

Marrow Plus (M+™) is intended for use as a system for the aspiration of bone marrow, Marrow Prus (MF+++) Is micheca for as a syments. Prior to use, the syring is either autologous blood, plasma or other blood composition of bone void filler (allograft, autograft or pre-filled or fined with the surgeon s one.co or others of on with a convenient way to synnelle bolle gran material). This bytech por read in and deliver the material to the orthopaedic surgical site.

M+ may be pre-filled with synthetic bone substitute (Bi-Ostetic, Cem-Osetic, Tri-Ostetic, BioPlus, GenerOs) shaped as granules or blocks (cancellous, cortical or cortical or cortico-Ostello, Blor lus, Generosy shaped to fill voids and gaps that are not intrinsic to the cancenous) that are michure. These gaps or voids may be located in the extremittes, stability of the bone suactare. These gaps or ressed into the void or into the void or into the spine, pervis, or crainan. The granules or blocks provide void filling material that acts as a surgical site by hand. The granules or blocks are not intended to provide structural temporary support median. The grandiso or out is radio-opaque. It is biocompatible and resorbs in the body as bone ingrowth occurs.

Prescription Use J (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eric G. Olson

1.810n Sign-Off) ision of General, Restorative turnlogical Devices

K051695