Recognized Consensus Standards

Recognition List Number: 022 Publication Date: 09/08/2009

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 8-188: ISO 13779-2:2008(E), Implants for surgery - Hydroxyapatite - Part 2: Coatings of hydroxyapatite. (Materials)

Date of Standard: 2008.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

Devices Affected:

Orthopedic implants including various components of the following joint replacement devices: Hip, Knee, and Shoulder Prostheses

Processes Affected:

510(k), PMA, IDE, PDP, HDE, Design Controls

Type of Standard:

International, Vertical

Extent of Recognition:

Complete standard. Additional information must be provided to demostrate that the design of the product will provide adequate mechanical properties for the particular device application. In applications subjected to wear or articulation additional data must be provided to demonstrate resistance to wear and abrasion.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§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

Regulation Number	Device Name	Device Class	Product Code
§888.3535	Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer	Class 2	NJD

Regulation Number	Device Name	Device Class	Product Code
§888.3565	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class 2	MBH

Regulation Number	Device Name	Device Class	Product Code
§888.3670	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Class 2	MBF

Relevant Guidance:

Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, April 28, 1994

510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants, March 10, 1995 (revised 2/20/97)

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004

FDA Technical Contacts:

Daniel Clupper

FDA/CDRH/ODE

10903 New Hampshire Avenue Building 66, Room 2572

Silver Spring MD 20993

301/796-6473

Email: daniel.clupper@fda.hhs.gov

Hany Demian

FDA/CDRH/ODE

10903 New Hampshire Avenue Building 66, Room 1528

Silver Spring MD 20993

301/796-6420