ASTM F2224-09 (Reapproved 2014)

Standard Organization:

ASTM F2224-09 (Reapproved 2014)
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants

Recognition Date2016-06-27
Recognition List043
Recognition Number8-429
Extent Complete standard
Standards Orgs ASTM ASTM International http://www.astm.org/
STG Materials
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

1.1 This specification covers material requirements for unfabricated and fabricated forms of hydrated calcium sulfate intended for surgical implants. Fabricated forms may include pressed and cast surgical implants in various geometric shapes. The calcium sulfate hemihydrate in the unfabricated form can be converted with the addition of water or other water-containing solutions to a fabricated calcium sulfate dihydrate form.

1.2 The requirements of this specification apply to calcium sulfate combined with two molecules of water or two calcium sulfate molecules sharing one water molecule.

Approximate chemical formulae:

Calcium Sulfate Dihydrate

CaSO4·2H2O

Calcium Sulfate Hemihydrate

CaSO4·1/2H2O or CaSO4·H2O·CaSO4

1.3 This specification specifically excludes calcium sulfate anhydrite and calcium sulfate forms that contain additives such as reinforcing phases, medicaments, biological agents, and so forth.

1.4 The presence of processing aids does not exclude a product from the physical and mechanical requirements of this specification.

1.5 Some provisions of Specification C59/C59M and Test Methods C472 apply. Special requirements that are detailed in this specification are included to characterize the material which will be used in surgical implants.

1.6 The biological response to calcium sulfate in bone tissue has been well characterized by a history of clinical use (1-14)2 and by laboratory studies (15-18).

1.7 The following precautionary caveat pertains only to the test method portion, Sections 4, 5, and 6, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§888.3358 Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Class 2 OQG
§888.3358 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class 2 LPH
§888.3358 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Class 2 MBL
§888.3353 Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Class 2 OQI
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Class 2 MAY
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
§888.3353 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class 2 MEH
§888.3045 Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation Class 2 OIS
§888.3045 Filler, Bone Void, Calcium Compound Class 2 MQV
§888.3045 Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Class 2 MBP

FDA Guidance:

Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA (February 7, 2002; revised June 2, 2003).

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