Recognized Consensus Standards

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

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 11-199: ASTM F 565-04 (Reapproved 2009)e1, Standard Practice for Care and Handling of Orthopedic Implants and Instruments. (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:

Metallic Implants

Processes Affected:

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

Type of Standard:

 International, Test Methods, Horizontal

Extent of Recognition:

This is one of a series of standardized methods of treating and inspecting manufactured products.

Related CFR Citations and Product Codes:

No Product Code information listed for §888
Regulation Number	Device Name	Device Class	Product Code
§888.3000	Cap, Bone	Class 1	JDT
Regulation Number	Device Name	Device Class	Product Code
§888.3010	Cerclage, Fixation	Class 2	JDQ
§888.3010	Cerclage, Fixation, Metallic	Class 2	NDD
Regulation Number	Device Name	Device Class	Product Code
§888.3015	Bone, Heterograft	Class 3	NVC
Regulation Number	Device Name	Device Class	Product Code
§888.3020	Rod, Fixation, Intramedullary And Accessories	Class 2	HSB
§888.3020	Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible	Class 2	NDE
Regulation Number	Device Name	Device Class	Product Code
§888.3025	Prosthesis, Tendon, Passive	Class 2	HXA
Regulation Number	Device Name	Device Class	Product Code
§888.3027	Bone Cement	Class 2	LOD
§888.3027	Bone Cement, Antibiotic	Class 2	MBB
§888.3027	Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty	Class 2	OBL
§888.3027	Cement, Bone, Vertebroplasty	Class 2	NDN
§888.3027	Cement, Bone, Vertebroplasty, Pre-Formed, Modular	Class 2	OBM
§888.3027	Vertebroplasty Compound, Calcium Based	Class 2	NUD
Regulation Number	Device Name	Device Class	Product Code
§888.3030	Anchor, Suture, Bone Fixation, Metallic	Class 2	NOV
§888.3030	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class 2	KTT
§888.3030	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Class 2	LXT
§888.3030	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Class 2	KTW
§888.3030	Appliance, Nail/Blade/Plate Combination, Single Component	Class 2	KWK
§888.3030	Condylar Plate Fixation Implant	Class 2	JDP
§888.3030	Device, Fixation, Proximal Femoral, Implant	Class 2	JDO
§888.3030	Electronic Depth Gauge	Class 2	OOL
§888.3030	Fastener, Fixation, Biodegradable, Soft Tissue	Class 2	MAI
§888.3030	Fixation Accessory	Class 2	LYT
§888.3030	Nail, Fixation, Bone	Class 2	JDS
§888.3030	Nail, Fixation, Bone, Metallic	Class 2	NDH
§888.3030	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Class 2	OBT
§888.3030	Plate, Fixation, Bone	Class 2	HRS
§888.3030	Plate, Fixation, Bone, Non-Spinal, Metallic	Class 2	NDF
§888.3030	Staple, Absorbable	Class 2	MNU
§888.3030	Staple, Fixation, Bone	Class 2	JDR
§888.3030	Staple, Fixation, Bone, Metallic	Class 2	NDI
§888.3030	Washer, Bolt Nut	Class 2	HTN
§888.3030	Washer, Bolt, Nut, Non-Spinal, Metallic	Class 2	NDG
Regulation Number	Device Name	Device Class	Product Code
§888.3040	Accessory, System, External Fixator, Containing Antimicrobial Agent	Class 2	NJA
§888.3040	Component, Traction, Invasive	Class 2	JEC
§888.3040	Fastener, Fixation, Nondegradable, Soft Tissue	Class 2	MBI
§888.3040	Kit, Laparoscopic, Bone Anchor, Urethropexy	Class 2	NWN
§888.3040	Pin, Fixation, Smooth	Class 2	HTY
§888.3040	Pin, Fixation, Smooth, Metallic	Class 2	NDL
§888.3040	Pin, Fixation, Threaded	Class 2	JDW
§888.3040	Pin, Fixation, Threaded, Metallic	Class 2	NDM
§888.3040	Screw, Fixation, Bone	Class 2	HWC
§888.3040	Screw, Fixation, Bone, Non-Spinal, Metallic	Class 2	NDJ
§888.3040	System, External Fixator (With Metallic Invasive Components)	Class 2	NDK
Regulation Number	Device Name	Device Class	Product Code
§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
Regulation Number	Device Name	Device Class	Product Code
§888.3050	Accessories, Fixation, Spinal Interlaminal	Class 2	LYP
§888.3050	Appliance, Fixation, Spinal Interlaminal	Class 2	KWP
§888.3050	Orthosis, Spine, Plate, Laminoplasty, Metal	Class 2	NQW
§888.3350	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Class 2	OQH
Regulation Number	Device Name	Device Class	Product Code
§888.3060	Appliance, Fixation, Spinal Intervertebral Body	Class 2	KWQ
§888.3060	Implant, Fixation Device, Spinal	Class 2	JDN
§888.3060	Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh	Class 2	OJM
§888.3060	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate	Class 2	OJB
Regulation Number	Device Name	Device Class	Product Code
§888.3070	Orthosis, Spinal Pedicle Fixation	Class 2	MNI
§888.3070	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease	Class 3	NKB
§888.3070	Orthosis, Spondylolisthesis Spinal Fixation	Class 2	MNH
§888.3070	Posterior Metal/Polymer Spinal System, Fusion	Class 2	NQP
Regulation Number	Device Name	Device Class	Product Code
§888.3080	Intervertebral Fusion Device With Bone Graft, Cervical	Class 2	ODP
§888.3080	Intervertebral Fusion Device With Bone Graft, Lumbar	Class 2	MAX
Regulation Number	Device Name	Device Class	Product Code
§888.3100	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite	Class 2	KMD
Regulation Number	Device Name	Device Class	Product Code
§888.3110	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Class 2	HSN
Regulation Number	Device Name	Device Class	Product Code
§888.3120	Prosthesis, Ankle, Cemented, Non-Constrained	Class 3	KXC
Regulation Number	Device Name	Device Class	Product Code
§888.3150	Prosthesis, Elbow, Constrained, Cemented	Class 2	JDC
Regulation Number	Device Name	Device Class	Product Code
§888.3160	Prosthesis, Elbow, Semi-Constrained, Cemented	Class 2	JDB
Regulation Number	Device Name	Device Class	Product Code
§888.3170	Prosthesis, Elbow, Hemi-, Radial, Polymer	Class 2	KWI
Regulation Number	Device Name	Device Class	Product Code
§888.3180	Prosthesis, Elbow, Hemi-, Humeral, Metal	Class 3	KWJ
Regulation Number	Device Name	Device Class	Product Code
§888.3200	Prosthesis, Finger, Constrained, Metal, Uncemented	Class 3	KWE
Regulation Number	Device Name	Device Class	Product Code
§888.3210	Prosthesis, Finger, Constrained, Metal, Cemented	Class 3	LBC
Regulation Number	Device Name	Device Class	Product Code
§888.3220	Prosthesis, Finger, Constrained, Metal/Polymer	Class 3	KWG
Regulation Number	Device Name	Device Class	Product Code
§888.3230	Prosthesis, Finger, Constrained, Polymer	Class 2	KYJ
§888.3230	Prosthesis, Finger, Polymer	Class 2	KWF
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
§888.3320	Spacer, Cement	Class 3	LTO
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	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
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
§888.3060	Spinal Vertebral Body Replacement Device	Class 2	MQP
§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
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
§888.3535	Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer	Class 2	NJD
Regulation Number	Device Name	Device Class	Product Code
§888.3540	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 + Additive/Metal/Polymer + Additive	Class 2	OIY
§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
§882.4650	Needle, Neurosurgical Suture	Class 1	HAS
§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
Regulation Number	Device Name	Device Class	Product Code
§888.3640	Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented	Class 3	KWR
Regulation Number	Device Name	Device Class	Product Code
§888.3650	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Class 2	KWT
Regulation Number	Device Name	Device Class	Product Code
§888.3660	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class 2	KWS
Regulation Number	Device Name	Device Class	Product Code
§888.3670	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Class 2	MBF
Regulation Number	Device Name	Device Class	Product Code
§888.3680	Metallic Cemented Glenoid Hemi-Shoulder Prosthesis	Class 3	KYM
Regulation Number	Device Name	Device Class	Product Code
§888.3690	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class 2	HSD
Regulation Number	Device Name	Device Class	Product Code
§888.3720	Prosthesis, Toe, Constrained, Polymer	Class 2	KWH
Regulation Number	Device Name	Device Class	Product Code
§888.3730	Prosthesis, Toe, Hemi-, Phalangeal	Class 2	KWD
Regulation Number	Device Name	Device Class	Product Code
§888.3750	Prosthesis, Wrist, Carpal Lunate	Class 2	KWN
Regulation Number	Device Name	Device Class	Product Code
§888.3760	Prosthesis, Wrist, Carpal Scaphoid	Class 2	KWO
Regulation Number	Device Name	Device Class	Product Code
§888.3770	Prosthesis, Wrist, Carpal Trapezium	Class 2	KYI
Regulation Number	Device Name	Device Class	Product Code
§888.3780	Prosthesis, Wrist, Constrained, Polymer	Class 2	KIG
Regulation Number	Device Name	Device Class	Product Code
§888.3790	Prosthesis, Wrist, Constrained, Metal	Class 3	KYN
Regulation Number	Device Name	Device Class	Product Code
§888.3800	Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained	Class 2	JWI
§888.3800	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained	Class 2	JWJ
§888.3800	Prosthesis, Wrist, Semi-Constrained	Class 2	KWM
Regulation Number	Device Name	Device Class	Product Code
§888.3810	Prosthesis, Wrist, Hemi-, Ulnar	Class 2	KXE
Regulation Number	Device Name	Device Class	Product Code
§888.4150	Caliper	Class 1	KTZ
Regulation Number	Device Name	Device Class	Product Code
§888.4200	Dispenser, Cement	Class 1	KIH
§888.4200	Injector, Vertebroplasty (Does Not Contain Cement)	Class 1	OAR
Regulation Number	Device Name	Device Class	Product Code
§888.4210	Mixer, Cement, For Clinical Use	Class 1	JDZ
Regulation Number	Device Name	Device Class	Product Code
§888.4220	Evacuator, Vapor, Cement Monomer	Class 1	JDY
Regulation Number	Device Name	Device Class	Product Code
§888.4230	Tube, Cement Ventilation	Class 1	KII
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	Bone Mill	Class 1	LYS
§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	Fork	Class 1	HXE
§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	Spinal Channeling Instrument, Vertebroplasty	Class 1	OCJ
§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
§888.4580	Instrument, Surgical, Sonic And Accessory/Attachment	Class 2	JDX
§888.4580	System, Cement Removal Extraction	Class 2	LZV
Regulation Number	Device Name	Device Class	Product Code
§888.4600	Protractor	Class 1	HTH
Regulation Number	Device Name	Device Class	Product Code
§888.4800	Template	Class 1	HWT

Relevant Guidance:

There is no relevant guidance developed at this time.

FDA Technical Contact:

  Ronald Jean

  FDA/CDRH/ODE

  10903 New Hampshire Avenue Building 66, Room 1414

  Silver Spring MD 20993

  301/796-5650

  Email: ronald.jean@fda.hhs.gov