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K Number
K030178
Device Name
CALCIGEN PSI BONE GRAFT SUBSTITUTE
Manufacturer
BIOMET, INC.
Date Cleared
2003-02-26

(40 days)

Product Code
MQV
Regulation Number
888.3045
Type
Traditional
Panel
OR
Reference & Predicate Devices
K020986,K013072,K011531,K013960,K013966,K014156,K014053,K011048,K994337,K990131
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 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.

AI/ML Overview

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.

§ 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.