• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 11-199
Standard
ASTM F565-04 (Reapproved 2018)
Standard Practice for Care and Handling of Orthopedic Implants and Instruments
Scope/Abstract
1.1 This practice covers recommended procedures for the handling of orthopedic implants and instruments.

1.2 Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage to orthopedic implants and instruments.

1.3 This practice does not cover producer level handling and packaging procedures.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§888.4800 Template Class 1 HWT
§888.4600 Protractor Class 1 HTH
§888.4580 Instrument, Surgical, Sonic And Accessory/Attachment Class 2 JDX
§888.4580 System, Cement Removal Extraction Class 2 LZV
§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
§888.4300 Gauge, Depth Class 1 HTJ
§888.4230 Tube, Cement Ventilation Class 1 KII
§888.4220 Evacuator, Vapor, Cement Monomer Class 1 JDY
§888.4210 Mixer, Cement, For Clinical Use Class 1 JDZ
§888.4200 Dispenser, Cement Class 1 KIH
§888.4200 Injector, Vertebroplasty (Does Not Contain Cement) Class 1 OAR
§888.4150 Caliper Class 1 KTZ
§888.3810 Prosthesis, Wrist, Hemi-, Ulnar Class 2 KXE
§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
§888.3790 Prosthesis, Wrist, Constrained, Metal Class 3 KYN
§888.3780 Prosthesis, Wrist, Constrained, Polymer Class 2 KIG
§888.3770 Prosthesis, Wrist, Carpal Trapezium Class 2 KYI
§888.3760 Prosthesis, Wrist, Carpal Scaphoid Class 2 KWO
§888.3750 Prosthesis, Wrist, Carpal Lunate Class 2 KWN
§888.3730 Prosthesis, Toe, Hemi-, Phalangeal Class 2 KWD
§888.3720 Prosthesis, Toe, Constrained, Polymer Class 2 KWH
§888.3690 Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Class 2 HSD
§888.3680 Metallic Cemented Glenoid Hemi-Shoulder Prosthesis Class 3 KYM
§888.3670 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class 2 MBF
§888.3660 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class 2 KWS
§888.3650 Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Class 2 KWT
§888.3640 Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented Class 3 KWR
§888.3590 Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) Class 2 HSH
§888.3580 Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented Class 2 HTG
§882.4650 Needle, Neurosurgical Suture Class 1 HAS
§888.3570 Prosthesis, Knee, Hemi-, Femoral (Uncemented) Class 3 KRS
§888.3565 Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 2 MBH
§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
§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
§888.3540 Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Class 2 KRR
§888.3535 Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer Class 2 NJD
§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
§888.3520 Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Class 2 HSX
§888.3510 Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Class 2 KRO
§888.3500 Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite Class 2 KYK
§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
§888.3480 Metal Cemented Constrained Femorotibial Knee Prosthesis Class 3 KRN
§888.3480 Prosthesis, Knee, Hinged (Metal-Metal) Class 3 HRZ
§888.3410 Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer Class 3 KXB
§888.3410 Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented Class 3 OCG
§888.3400 Prosthesis, Hip, Femoral, Resurfacing Class 2 KXA
§888.3390 Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Class 2 KWY
§888.3370 Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal Class 3 KWB
§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
§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
§888.3350 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class 2 JDI
§888.3340 Prosthesis, Hip, Semi-Constrained, Composite/Metal Class 2 KMC
§888.3330 Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Class 3 KWA
§888.3320 Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Class 3 JDL
§888.3320 Spacer, Cement Class 3 LTO
§888.3310 Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Class 2 KWZ
§888.3300 Prosthesis, Hip, Constrained, Metal Class 3 KXD
§888.3230 Prosthesis, Finger, Constrained, Polymer Class 2 KYJ
§888.3230 Prosthesis, Finger, Polymer Class 2 KWF
§888.3220 Prosthesis, Finger, Constrained, Metal/Polymer Class 3 KWG
§888.3210 Prosthesis, Finger, Constrained, Metal, Cemented Class 3 LBC
§888.3200 Prosthesis, Finger, Constrained, Metal, Uncemented Class 3 KWE
§888.3180 Prosthesis, Elbow, Hemi-, Humeral, Metal Class 3 KWJ
§888.3170 Prosthesis, Elbow, Hemi-, Radial, Polymer Class 2 KWI
§888.3160 Prosthesis, Elbow, Semi-Constrained, Cemented Class 2 JDB
§888.3150 Prosthesis, Elbow, Constrained, Cemented Class 2 JDC
§888.3120 Prosthesis, Ankle, Cemented, Non-Constrained Class 3 KXC
§888.3110 Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Class 2 HSN
§888.3100 Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite Class 2 KMD
§888.3080 Intervertebral Fusion Device With Bone Graft, Cervical Class 2 ODP
§888.3080 Intervertebral Fusion Device With Bone Graft, Lumbar Class 2 MAX
§888.3070 Orthosis, Spinal Pedicle Fixation Class 2 MNI
§888.3070 Orthosis, Spondylolisthesis Spinal Fixation Class 2 MNH
§888.3070 Posterior Metal/Polymer Spinal System, Fusion Class 2 NQP
§888.3070 Thoracolumbosacral Pedicle Screw System Class 2 NKB
§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
§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
§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
§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 Laparoscopic Bone Anchor Urethropexy Instrument Kit 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
§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
§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
§888.3025 Prosthesis, Tendon, Passive Class 2 HXA
§888.3020 Rod, Fixation, Intramedullary And Accessories Class 2 HSB
§888.3020 Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible Class 2 NDE
§888.3015 Bone, Heterograft Class 3 NVC
§888.3010 Cerclage, Fixation Class 2 JDQ
§888.3010 Cerclage, Fixation, Metallic Class 2 NDD
§888.3000 Cap, Bone Class 1 JDT
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance published at this time.
FDA Technical Contacts
 Jonathan Peck
  FDA/OMPT/CDRH/ODE/DOD/PSDB/
  301-796-5650
  jonathan.peck@fda.hhs.gov
 Christopher Ferreira
  FDA/OMPT/CDRH/ODE/DOD/JFDB2/
  301-796-9350
  christopher.ferreira@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
-
-