(40 days)
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.
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.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for a bone graft substitute called Calcigen™ PSI.
It describes:
- The device (Calcigen™ PSI bone graft substitute)
- Its intended use (filling bony voids or gaps)
- Its composition (60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP))
- Its substantial equivalence to other legally marketed predicate devices.
The FDA clearance is based on the device being "substantially equivalent" to predicate devices, implying similar performance and safety characteristics. However, there are no specific numerical acceptance criteria or a study with performance metrics presented in this document. The clearance letter confirms that the device can be marketed based on this substantial equivalence determination, not based on meeting specific, predefined performance criteria from a clinical or analytical study.
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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 BoneVoid 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 CancellousBone Void Filler | Orthovita Co. | K994337 | |
| Pro Osteon Implant 500R ResorbableBone 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.
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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
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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
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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
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
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.(b)
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.