CONDUIT TCP GRANULES

{0}------------------------------------------------ K014053 Conduit™ TCP Granules 510(k) Summary IX. SUBMIT ## 8 2002 MAR | TER: | DePuy AcroMed ^TM , Inc. | |------|------------------------------------| | | 325 Paramount Drive | | | Raynham, MA 02767-0350 USA | Karen F. Jurczak CONTACT PERSON: December 07, 2001 DATE PREPARED: Conduit™ TCP Granules PROPRIETARY NAME: Bone Graft Substitute Material, Bone Void Filler CLASSIFICATION NAME: PREDICATE DEVICE: ♦ Orthovita VITOSS (K994337) � Pro Osteon 500R Resorbable Bone Graft Substitute (K990131) INTENDED USE: The Conduit™ TCP Granules are indicated for filling bone voids or defects of the skeletal system (such as the extremities, spine, and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Conduit™ TCP Granules is a bone graft substitute that resorbs and is replaced with bone during the healing process. MATERIALS: > 99% Beta-Tri Calcium Phosphate (β-ΤCP) Саз(РО4)2 PERFORMANCE DATA: Physico-Chemical Characterization testing and animal testing were conducted. Conduit™ TCP Granules are a synthetic material, obtained DEVICE DESCRIPTION: after high-temperature ceramicization of a mixture of tribasic calcium phosphate. The Conduit™ TCP Granules composed of interconnected pores occupying are approximately 70% of the volume of the implant, and ranging in diameter between 1 and 600 um. > Conduit™ TCP Granules come in the form of irregular shaped granules having an average diameter between 1.5 and 3 mm inclusive. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation. The overall design is simple yet recognizable, representing the department's role in public health and welfare. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 8 2002 Mr. Frank Maas Director, Regulatory Affairs DePuy AcroMed 325 Paramount Drive Raynham, Massachusetts 02767-0350 Re: K014053 Conduit™ TCP Granules Regulatory Class: unclassified Product Code: MQV Dated: December 7, 2001 Received: December 10, 2001 Dear Mr. Maas: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becases on and the device is substantially equivalent (for the relerenced above and nave determined ire) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate conmicree prior to thay 20, 10, 10, 10, 10, 10, 2011, 10, 2011, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 Allendinents, on to devroes that have onct (Act) that do not require approval of a premarket the Federal Pood, Drug, and Ocomette , therefore, market the device, subject to the general approval application (1111). I The general controls provisions of the Act include Condois provisions of the Fish - 110 gisting 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 II your device is classified (500 above) into sontrols. Existing major regulations affecting (FMA), it may of subject to Such adata veral Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas received. 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 I least that FDA has made a determination that your device complies with other requirements modifinal I DA mas made a actes and regulations administered by other Federal agencies. or the Act of ally 1 oderal bullated is requirements, including, but not limited to: registration 1 od inust compry with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), idositing systems (QS) regulation (21 CFR Part 820); and if {2}------------------------------------------------ ## Page 2 - Mr. Frank Maas 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 while in Jourse 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your at (301) 594-1637. The Office of Compliance at (301) 594-4639. Also, please note the ac regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general Manifacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Sincerely yours, Mark N Melkus Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices Enclosure {3}------------------------------------------------ ## Indications for Use IV. 510(k) Number (if known): Conduit™ TCP Granules Device Name: ## Indications For Use: The Conduit™ TCP Granules are indicated for filling bone voids or defects of the skeletal The Colludil "TOP Orandies are indisated for the pelvis) that are not intrinsic to the system (Such as the "Extremator, "Spino, "and "and the surgically created osseous defects Stablity of the bony structure. "Those acrossive in the bone. Conduit™ TCP Granules is of Usseous delects created from tradination injury to the a with bone during the healing process. (Please do not write below this line - continue on another page if needed) | | Concurrence of CDRH, Office of Device Evaluation (ODE) | |-------------------------------------------|------------------------------------------------------------------------------------------------------| | Prescription Use:<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use: | | | ivision Sign-Off)<br>Division of General, Restorative<br>and Neurological Devices<br>510(k) Number . |