| ASTM F565-04 (Reapproved 2018) Standard Practice for Care and Handling of Orthopedic Implants and Instruments |
| Recognition Number | Orthopedic |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 11-199 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Orthopedic |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| 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 |
| There is no relevant guidance published at this time. | |