Recognized Consensus Standards

Recognition List Number: 028 Publication Date: 03/16/2012

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 11-226: ASTM F1089-10, Standard Test Method for Corrosion of Surgical Instruments. (Orthopaedics)

Date of Standard: 2010.

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:

Metallic Surgical Instruments

Processes Affected:

510(K) AND MDR Review, Design Controls

Type of Standard:

Test Methods, National, Horizontal

Extent of Recognition:

Complete Document.
Methods used to determine corrosion resistance of instruments. Other material and device standards also apply.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
Unclassified	Accessories, Fixation, Spinal Intervertebral Body	Class U	LYQ
Unclassified	Guide, Drill, Ligament	Class U	LXI

Regulation Number	Device Name	Device Class	Product Code
§888.3050	Accessories, Fixation, Spinal Interlaminal	Class 2	LYP

Regulation Number	Device Name	Device Class	Product Code
§888.4300	Gauge, Depth	Class 1	HTJ

Regulation Number	Device Name	Device Class	Product Code
§888.4540	Applier, Cerclage	Class 1	HXN
§888.4540	Awl	Class 1	HWJ
§888.4540	Bender	Class 1	HXW
§888.4540	Bit, Drill	Class 1	HTW
§888.4540	Brace, Drill	Class 1	HXY
§888.4540	Broach	Class 1	HTQ
§888.4540	Burr, Orthopedic	Class 1	HTT
§888.4540	Corkscrew	Class 1	HWI
§888.4540	Countersink	Class 1	HWW
§888.4540	Crimper, Pin	Class 1	HXQ
§888.4540	Cutter, Wire	Class 1	HXZ
§888.4540	Driver, Prosthesis	Class 1	HWR
§888.4540	Extractor	Class 1	HWB
§888.4540	File	Class 1	HTP
§888.4540	Holder, Needle; Orthopedic	Class 1	HXK
§888.4540	Impactor	Class 1	HWA
§888.4540	Instrument, Bending Or Contouring	Class 1	HXP
§888.4540	Instrument, Compression	Class 1	HWN
§888.4540	Knife, Orthopedic	Class 1	HTS
§888.4540	Orthopedic Manual Surgical Instrument	Class 1	LXH
§888.4540	Passer	Class 1	HWQ
§888.4540	Passer, Wire, Orthopedic	Class 1	HXI
§888.4540	Positioner, Socket	Class 1	KIL
§888.4540	Probe	Class 1	HXB
§888.4540	Punch, Femoral Neck	Class 1	HWP
§888.4540	Pusher, Socket	Class 1	HXO
§888.4540	Reamer	Class 1	HTO
§888.4540	Rongeur	Class 1	HTX
§888.4540	Scissors, Orthopedic, Surgical	Class 1	HRR
§888.4540	Screwdriver	Class 1	HXX
§888.4540	Set, Hollow Mill	Class 1	HWL
§888.4540	Skid, Bone	Class 1	HWO
§888.4540	Staple Driver	Class 1	HXJ
§888.4540	Starter, Bone Screw	Class 1	HWD
§888.4540	Stripper, Surgical	Class 1	HRT
§888.4540	Tamp	Class 1	HXG
§888.4540	Tap, Bone	Class 1	HWX
§888.4540	Trephine	Class 1	HWK
§888.4540	Twister, Wire	Class 1	HXS
§888.4540	Wrench	Class 1	HXC

Regulation Number	Device Name	Device Class	Product Code
§888.4800	Template	Class 1	HWT