Recognized Consensus Standards

Recognition List Number: 025 Publication Date: 10/04/2010 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 11-171: ASTM F 1814-97a (Reapproved 2009), Standard Guide for Evaluating Modular Hip and Knee Joint Components. (Orthopaedics)

Date of Standard: 2009. 

Address of Standards Organization:

  ASTM International (ASTM)

  100 Barr Harbor Drive

  West Conshohocken, PA 19428-2959

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Tibial inserts, metal tibial trays, metal-backed patellae, stem extensions, wedges, and femoral components of modular total knee replacements (TKR)

Processes Affected:

510(K), PMA, IDE, PDP, Design Controls

Type of Standard:

 Vertical, International

Extent of Recognition:

Complete Standard.

This guide covers a procedure to assist the developer of a modular joint replacement implant in the choice of appropriate tests and evaluations to determine device safety.

Addition information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application. In applications subjected to wear or articulation, additional data may be needed to document resistance to wear and abrasion.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
Unclassified	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer	Class 3	LXY
Unclassified	Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class 3	MBD
Regulation Number	Device Name	Device Class	Product Code
Unclassified	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented	Class 3	LPF
Unclassified	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented	Class 3	MRA
Regulation Number	Device Name	Device Class	Product Code
Unclassified	Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing	Class 3	NXT
Unclassified	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing	Class 3	NRA
Unclassified	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	Class 3	NJL
Regulation Number	Device Name	Device Class	Product Code
§888.3300	Prosthesis, Hip, Constrained, Metal	Class 3	KXD
Regulation Number	Device Name	Device Class	Product Code
§888.3310	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class 2	KWZ
Regulation Number	Device Name	Device Class	Product Code
§888.3320	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Class 3	JDL
Regulation Number	Device Name	Device Class	Product Code
§888.3330	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Class 3	KWA
Regulation Number	Device Name	Device Class	Product Code
§888.3340	Prosthesis, Hip, Semi-Constrained, Composite/Metal	Class 2	KMC
Regulation Number	Device Name	Device Class	Product Code
§888.3350	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Class 2	OQH
§888.3350	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Class 2	JDI
Regulation Number	Device Name	Device Class	Product Code
§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, Calicum-Phosphate	Class 2	MEH
§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
§888.3358	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
Regulation Number	Device Name	Device Class	Product Code
§888.3360	Prosthesis, Hip, Femoral Component, Cemented, Metal	Class 2	JDG
§888.3360	Prosthesis, Hip, Hemi-, Femoral, Metal	Class 2	KWL
§888.3360	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Class 2	LZY
§888.3360	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Class 2	LWJ
§888.3360	Prosthesis, Upper Femoral	Class 2	JDD
§888.3560	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class 2	NPJ
§888.3560	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Class 2	OIY
Regulation Number	Device Name	Device Class	Product Code
§888.3370	Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal	Class 3	KWB
Regulation Number	Device Name	Device Class	Product Code
§888.3390	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class 2	KWY
Regulation Number	Device Name	Device Class	Product Code
§888.3400	Prosthesis, Hip, Femoral, Resurfacing	Class 2	KXA
Regulation Number	Device Name	Device Class	Product Code
§888.3410	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer	Class 3	KXB
§888.3410	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented	Class 3	OCG
Regulation Number	Device Name	Device Class	Product Code
§888.3480	Metal Cemented Constrained Femorotibial Knee Prosthesis	Class 3	KRN
§888.3480	Prosthesis, Knee, Hinged (Metal-Metal)	Class 3	HRZ
Regulation Number	Device Name	Device Class	Product Code
§888.3490	Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented	Class 2	KTX
§888.3490	Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented	Class 2	KMB
Regulation Number	Device Name	Device Class	Product Code
§888.3500	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite	Class 2	KYK
Regulation Number	Device Name	Device Class	Product Code
§888.3510	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Class 2	KRO
Regulation Number	Device Name	Device Class	Product Code
§888.3520	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Class 2	HSX
Regulation Number	Device Name	Device Class	Product Code
§888.3530	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Class 2	HRY
§888.3530	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing	Class 2	LGE
Regulation Number	Device Name	Device Class	Product Code
§888.3540	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Class 2	KRR
Regulation Number	Device Name	Device Class	Product Code
§888.3550	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal	Class 3	KRP
§888.3550	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer	Class 2	KRQ
Regulation Number	Device Name	Device Class	Product Code
§888.3560	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	Class 2	MBV
§888.3560	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class 2	JWH
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
§888.3570	Prosthesis, Knee, Hemi-, Femoral	Class 3	HSA
§888.3570	Prosthesis, Knee, Hemi-, Femoral (Uncemented)	Class 3	KRS
Regulation Number	Device Name	Device Class	Product Code
§888.3580	Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented	Class 2	HTG
Regulation Number	Device Name	Device Class	Product Code
§888.3590	Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)	Class 2	HSH

Relevant Guidance:

Guidance Document for Testing Non-Articulating, 'Mechanically Locked,' Modular Implant Components, May 1, 1995

FDA Technical Contact:

  John Goode

  FDA/CDRH/ODE

  10903 New Hampshire Avenue Building 66, Room 1510

  Silver Spring MD 20993

  301/796-6407

  Email: john.goode@fda.hhs.gov