CALCIGEN PSI BONE GRAFT SUBSTITUTE

K030178 · Biomet, Inc. · MQV · Feb 26, 2003 · Orthopedic

Device Facts

Record IDK030178
Device NameCALCIGEN PSI BONE GRAFT SUBSTITUTE
ApplicantBiomet, Inc.
Product CodeMQV · Orthopedic
Decision DateFeb 26, 2003
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3045
Device ClassClass 2
AttributesTherapeutic

Intended Use

Calcigen™ PSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and 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 disease or traumatic injury to the bone. Calcigen™ PSI resorbs and is replaced with bone during the healing process.

Device Story

Calcigen™ PSI is a resorbable, osteoconductive bone graft substitute; composed of 60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP). Available as granules, cubes, or cylinders; features multidirectional interconnected pores mimicking cancellous bone. Used by surgeons to fill osseous defects in extremities, spine, and pelvis; acts as a scaffold for bone ingrowth; resorbs over time and is replaced by natural bone during healing. Supplied sterile for single-patient, one-time use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on material composition, structural similarity, and established physicochemical properties of calcium phosphate bone graft substitutes.

Technological Characteristics

Composition: 60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP). Form factor: Granules, cubes, or cylinders. Structure: Porous with multidirectional interconnected pores. Sterilization: Sterile for single-use.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to bony stability, resulting from surgery, disease, or trauma.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K 030178 Page 4 of 15 #### 510(k) Summary [as required by 21 CFR 807.92(c)] 2 # FFB 2 6 2003 ### Submitter's Name / Contact Person | Biomet, Inc. | Contact | |-----------------------|------------------------------| | 56 East Bell Drive | Mary Verstynen | | Warsaw. IN 46581-0587 | Director of Clinical Affairs | # General Information | Trade Name | Calcigen™ PSI bone graft substitute | | | |---------------------|-------------------------------------------------------------|-------------------------------|----------| | Common Name | Bone graft substitute; bone void filler | | | | Classification Name | Resorbable Calcium Salt Bone Void Filler | | | | Equivalent Devices | Product | Manufacturer | 510(k) # | | | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | K020986 | | | chronOS Tricalcium Phosphate | Synthes | K013072 | | | Calcium Phosphate Granular Bone<br>Void Filler | Biomet, Inc. | K011531 | | | Apatight HA-Bone Graft Substitute | Cerabio. LLC | K013960 | | | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | K013966 | | | Cerasorb Ortho | Curasan Ag | K014156 | | | Conduit TCP Granules | Depuy Acromed | K014053 | | | BSM Bone Substitute Material | Depuy Orthopaedics, Inc. | K011048 | | | Vitoss Scaffold Synthetic Cancellous<br>Bone Void Filler | Orthovita Co. | K994337 | | | Pro Osteon Implant 500R Resorbable<br>Bone Graft Substitute | Interpore Cross Intl. | K990131 | #### Device Description Calcigen™ PSI bone graft substitute is a resorbable osteoconductive scaffold composed of 60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP). The device is available as granules, cubes, or cylinders. Calcigen™ PSI is porous with multidirectional interconnected pores resembling that of cancellous bone. Calcigen™ PSI is supplied sterile for single patient, one time use only. #### Intended Use Calcigen™ PSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the bony structure. These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. Calcigen™ PSI resorbs and is replaced with bone during the healing process. # Substantial Equivalence Comparison Calcigen™ PSI is biocompatible because it is comprised of medical grade HA and TCP, which are known to be biocompatible with human bony tissue. Because of its substantial similarity in materials, structure, and porosity to several other FDA-cleared calcium phosphate bone graft substitutes, Calcigen™ PSI can be assumed to have appropriate physicochemical properties to create an adequate environment for bone ingrowth, permit device resorption, and result in adequate formation of bone. The submitted information demonstrated that Calcigen™ PSI bone graft substantially equivalent to the currently marketed predicate devices. {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 circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines suggesting hair or movement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 6 2003 Ms. Mary L. Verstynen Director of Clinical Affairs Biomet, Inc. P.O. Box 587 Warsaw, IN 46581-0587 Re: K030178 Calcigen™ PSI Bone Graft Substitute Regulatory Class: Unclassified Product Code: MQV Dated: January 15, 2003 Received: January 17, 2003 Dear Ms. Verstynen: 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 vour 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 (QS) regulation (21 CFR Part 820); and if {2}------------------------------------------------ Page 2 – Ms. Mary L. Verstynen 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark N Mulbers 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 {3}------------------------------------------------ Page 1 of 1 # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K030178 Device Name: Calcigen™ PSI bone graft substitute Indications for Use: Calcigen™ PSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and 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 disease or traumatic injury to the bone. Calcigen™ PSI resorbs and is replaced with bone during the healing process. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark N Milkman . Restorative 10(k) Number K030178
Innolitics
510(k) Summary
Decision Summary
Classification Order
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