OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM

K041089 · Biomet Manufacturing, Inc. · MQV · Aug 31, 2004 · Orthopedic

Device Facts

• Record ID: K041089
• Device Name: OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM
• Applicant: Biomet Manufacturing, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Aug 31, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OSS Bone Graft System and the OSS RapidSet Bone Graft System are indicated for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.

Device Story

OSS Bone Graft System and OSS RapidSet Bone Graft System are bone void fillers; supplied as separate powder and liquid components. Intraoperative mixing creates a homogenous paste for application into bone defects. Powder consists of ceramic calcium phosphate and sodium citrate dihydrate; liquid consists of anhydrous citric acid and distilled water. Used by surgeons in clinical settings to fill non-structural osseous defects. Paste hardens in situ to fill voids resulting from trauma, disease, or surgery. Benefits include providing a scaffold for bone repair.

Clinical Evidence

No clinical data provided. Bench testing included elemental analysis, set time determination, X-ray diffraction analysis, surface pH, and exothermic temperature measurement.

Technological Characteristics

Resorbable calcium salt bone void filler. Components: ceramic calcium phosphate powder, sodium citrate dihydrate, anhydrous citric acid, and distilled water. Form factor: powder and liquid for intraoperative mixing into a paste. Class II device (21 CFR 888.3045).

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities, spine, pelvis) caused by surgery, disease, or trauma. Not for use in defects intrinsic to structural integrity.

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

• K990290
• K023718
• K003494

Reference Devices

• α-BSM® Bone Substitute Material (K011048)
• Norian® SRS® Bone Void Filler (K011897)
• Pro Osteon® 500R Resorbable Bone Graft Substitute (K990131)

Submission Summary (Full Text)

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K04-1089

AUG 3 1 2004

BIOMET

#### 510(k) Summary

Applicant/Sponsor:Biomet Manufacturing Corp. P.O. Box 587 Warsaw, IN 46581

Patricia Sandborn Beres Contact Person: Senior Requlatory Specialist

Proprietary Name: OSS Bone Graft System and OSS RapidSet Bone Graft System

Common Name: Bone Graft Substitute

Classification Name: Resorbable calcium salt bone void filler device (21 CFR 888.3045)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The current product is identical to the material previously cleared through 510(k)s K990290, ourrent pland K023718 for craniofacial applications and K003494 for dental applications.

Products cleared for orthopedic applications include: α-BSM® Bone Substitute Material (K011048), Norian® SRS® Bone Void Filler (K011897) and Pro Osteon® 500R Resorbable Bone Graft Substitute (K990131).

Device Description: OSS Bone Graft System and OSS RapidSet Bone Graft System are packaged as separate, pre-measured powder and liquid components. The two components are to be mixed intraoperatively to produce a homogenous paste that car be applied to bone gaps or defects.

The powder component is a mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate. The liquid component is a solution comprised of anhydrous citric acid (C,H,O,) and distilled water (H₂O). When mixed, the powder and liquid combine to form a homogenous paste.

Intended Use: The OSS Bone Graft System and the OSS RapidSet Bone Graft System are indicated for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.

Image /page/0/Figure/14 description: The image shows the mailing address, shipping address, office number, fax number, and email address. The mailing address is P.O. Box 587, Warsaw, IN 46581 0587. The shipping address is 56 E. Bell Drive, Warsaw, IN 16582. The office number is 574.267.6639, the fax number is 574.267.8137, and the email address is [e-mail].

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Summary of Technologies: The materials, design and processing OSS Bone Graft System and OSS RapidSet Bone Graft System are similar or identical to the predicate products.

Non-Clinical Testing: Non-clinical testing provided included elemental analysis, a determination of set time, X-ray diffraction analysis, determination of surface pH, and exothermic temperature.

Clinical Testing: None provided

Mimix is a trademark of Walter Lorenz Surgical, a Biomet Company Tyvek is a trademark of trademark of E.I. duPont de Nemours and Company α-BSM is a trademark of DePuy Pro Osteon is a trademark of Interpore Cross International

Norian and SRS are trademarks of Synthes

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which represent the department's mission to enhance the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2004

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corporation P.O Box 587 Warsaw, Indiana 46581-0587

Re: K041089

OSS Bone Graft System and OSS RapidSet Bone Graft System Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: July 19, 2004 Received: July 20, 2004

Dear Ms. Sandborn Beres:

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

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### Page 2 - Ms. Patricia Sandborn Beres

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) I mis letter will anow you be object finding of substantial equivalence of your device to a premarket notification. - The PD Frinalis 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), If you desire specific at no for 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 may overn other generalational 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,

l Mark H. Milken

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):

# Device Name: OSS Bone Graft System and OSS RapidSet Bone Graft System

### Indications For Use:

The OSS Bone Graft System and the OSS RapidSet Bone Graft System are indicated
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for filling bony voids of the skeletal system (i.e., the extremes defects creat for filling bony volus of the skeller system (r.c.) the exarch or osseous defects created
These defects may be surgically created osseous in intended for hope voids or i hese defects may be suigically created observes in intended for bone voids or
from disease or traumatic injury to the bone. The device is intentire from disease of traumatio injury to the structural integrity of the bony structure.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N Milker
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number_ K041089