PROGENIX DBM PUTTY

K080462 · Medtronic Sofamor Danek · NUN · May 13, 2008 · Dental

Device Facts

Record IDK080462
Device NamePROGENIX DBM PUTTY
ApplicantMedtronic Sofamor Danek
Product CodeNUN · Dental
Decision DateMay 13, 2008
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3930
Device ClassClass 2
AttributesTherapeutic

Intended Use

PROGENIX™ DBM Putty is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to: Ridge augmentation Filling of cystic defect Filling of extraction sites Filling of lesions of periodontal origin Craniofacial augmentation Filling of defects of endodontic origin Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

Device Story

PROGENIX™ DBM Putty is a bone void filler composed of human demineralized bone matrix (DBM) in a carrier of bovine collagen and sodium alginate. Provided in a ready-to-use, malleable form, it is manipulated by surgeons in oral/maxillofacial clinical settings to fill osseous defects. The device is osteoconductive and osteoinductive; it facilitates bony ingrowth while resorbing at a rate consistent with natural healing. It is not designed to provide mechanical strength. The device is intended for single use.

Clinical Evidence

No clinical data. Evidence is based on bench testing and a validated athymic nude rat assay to confirm osteoinductivity of the DBM component.

Technological Characteristics

Composition: Human demineralized bone matrix (DBM), bovine collagen, sodium alginate, and phosphate buffered saline. Form: Malleable, ready-to-use putty. Function: Osteoconductive and osteoinductive bone void filler. Non-load bearing.

Indications for Use

Indicated for patients requiring augmentation of deficient maxillary and mandibular alveolar ridges or treatment of oralmaxillofacial and dental intraosseous defects, including cystic defects, extraction sites, periodontal lesions, craniofacial augmentation, endodontic defects, mandibular reconstruction, traumatic alveolar ridge defects (excluding fractures), and resection defects in benign bone tumors or cysts.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K080462 1 of z MAY 13 2008 Medtronic Sofamor Danek PROGENIX™ DBM Putty 510(k) Summary February 2008 l. Company: Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738 > Contact: Michelle Obenauer Regulatory Affairs Supervisor - II. Proposed Proprietary Trade Name: Classification Name: Product Code: Regulation No .: PROGENIX™ DBM Putty Bone Void Filler NUN 872.3930 ## III. Product Description/Purpose of Application PROGENIX™ DBM Putty contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. All DBM used in the preparation of PROGENIX™ DBM Putty must induce bone formation when evaluated in a validated athymic nude rat assay. Although, findings from an animal model are not necessarily predictive of human clinical results. PROGENIX™ DBM Putty is a single use product intended for use in the oralmaxillofacial region. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX™ DBM Putty is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing {1}------------------------------------------------ K080462 The purpose of this 510(k) application is to introduce PROGENIX™ DBM Putty into the market for the oralmaxillofacial applications listed on the Indications for Use Form. ## IV. Indications PROGENIX™ DBM Putty is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to: Ridge augmentation Filling of cystic defect Filling of extraction sites Filling of lesions of periodontal origin Craniofacial augmentation Filling of defects of endodontic origin Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall. ## V. Substantial Equivalence Documentation is provided which demonstrates PROGENIX™ DBM Putty to be substantially equivalent to previously cleared bone void fillers such as PROGENIX™ DBM Putty (Medtronic Sofamor Danek, K072265, SE 1/9/2008), PROGENIX™ DBM Putty (Medtronic Sofamor Danek, K060794, SE 12/18/06), DBX Demineralized Bone Matrix Putty and Paste (Musculoskeletal Transplant Foundation, K040501, SE 04/29/05), Accell Connexus™ DBM Putty (IsoTis, OrthoBiologics, Inc., K060306, SE 03/27/2006), Intergo® Oral (Biomet 3i, K070147, SE 05/14/2007), and GRAFTON® DBM (Osteotech, Inc., K051188, SE 01/03/2006). {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol resembling an eagle or bird in flight. The symbol is composed of thick, curved lines. Encircling the symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 3 2008 Ms. Michelle Obenauer Regulatory Affairs Supervisor Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennesse 38132 Re: K080462 Trade/Device Name: PROGENIX™M DBM Putty Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: February 12, 2008 Received: February 20, 2008 Dear Ms. Obenauer: 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. {3}------------------------------------------------ Page 2 - Ms. Obenauer 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 (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 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), please contact the Office of Compliance at (240) 276-0115. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Clars Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K080462 510(k) Number (if known): K080462 Device Name: PROGENIX™ DBM Putty Indications for Use: PROGENIX™ DBM Putty is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to: Ridge augmentation Filling of cystic defect Filling of extraction sites Filling of lesions of periodontal origin Craniofacial augmentation Filling of defects of endodontic origin Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Runner (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: KOF0442
Innolitics
510(k) Summary
Decision Summary
Classification Order
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