| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
050
|
Date of Entry 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/Abstract1.1 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
|
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 |
| §882.4650 |
Needle, Neurosurgical Suture
|
Class 1
|
HAS
|
| §888.3000 |
Cap, Bone
|
Class 1
|
JDT
|
| §888.3010 |
Cerclage, Fixation
|
Class 2
|
JDQ
|
| §888.3010 |
Cerclage, Fixation, Metallic
|
Class 2
|
NDD
|
| §888.3015 |
Bone, Heterograft
|
Class 3
|
NVC
|
| §888.3020 |
Rod, Fixation, Intramedullary And Accessories
|
Class 2
|
HSB
|
| §888.3020 |
Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible
|
Class 2
|
NDE
|
| §888.3025 |
Prosthesis, Tendon, Passive
|
Class 2
|
HXA
|
| §888.3027 |
Bone Cement
|
Class 2
|
LOD
|
| §888.3027 |
Bone Cement, Antibiotic
|
Class 2
|
MBB
|
| §888.3027 |
Cement, Bone, Vertebroplasty
|
Class 2
|
NDN
|
| §888.3027 |
Vertebroplasty Compound, Calcium Based
|
Class 2
|
NUD
|
| §888.3027 |
Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
|
Class 2
|
OBL
|
| §888.3027 |
Cement, Bone, Vertebroplasty, Pre-Formed, Modular
|
Class 2
|
OBM
|
| §888.3030 |
Plate, Fixation, Bone
|
Class 2
|
HRS
|
| §888.3030 |
Washer, Bolt Nut
|
Class 2
|
HTN
|
| §888.3030 |
Device, Fixation, Proximal Femoral, Implant
|
Class 2
|
JDO
|
| §888.3030 |
Condylar Plate Fixation Implant
|
Class 2
|
JDP
|
| §888.3030 |
Staple, Fixation, Bone
|
Class 2
|
JDR
|
| §888.3030 |
Nail, Fixation, Bone
|
Class 2
|
JDS
|
| §888.3030 |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
|
Class 2
|
KTT
|
| §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 |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
|
Class 2
|
LXT
|
| §888.3030 |
Fixation Accessory
|
Class 2
|
LYT
|
| §888.3030 |
Fastener, Fixation, Biodegradable, Soft Tissue
|
Class 2
|
MAI
|
| §888.3030 |
Staple, Absorbable
|
Class 2
|
MNU
|
| §888.3030 |
Plate, Fixation, Bone, Non-Spinal, Metallic
|
Class 2
|
NDF
|
| §888.3030 |
Washer, Bolt, Nut, Non-Spinal, Metallic
|
Class 2
|
NDG
|
| §888.3030 |
Nail, Fixation, Bone, Metallic
|
Class 2
|
NDH
|
| §888.3030 |
Staple, Fixation, Bone, Metallic
|
Class 2
|
NDI
|
| §888.3030 |
Anchor, Suture, Bone Fixation, Metallic
|
Class 2
|
NOV
|
| §888.3030 |
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
|
Class 2
|
OBT
|
| §888.3030 |
Electronic Depth Gauge
|
Class 2
|
OOL
|
| §888.3040 |
Pin, Fixation, Smooth
|
Class 2
|
HTY
|
| §888.3040 |
Screw, Fixation, Bone
|
Class 2
|
HWC
|
| §888.3040 |
Pin, Fixation, Threaded
|
Class 2
|
JDW
|
| §888.3040 |
Component, Traction, Invasive
|
Class 2
|
JEC
|
| §888.3040 |
Fastener, Fixation, Nondegradable, Soft Tissue
|
Class 2
|
MBI
|
| §888.3040 |
Screw, Fixation, Bone, Non-Spinal, Metallic
|
Class 2
|
NDJ
|
| §888.3040 |
System, External Fixator (With Metallic Invasive Components)
|
Class 2
|
NDK
|
| §888.3040 |
Pin, Fixation, Smooth, Metallic
|
Class 2
|
NDL
|
| §888.3040 |
Pin, Fixation, Threaded, Metallic
|
Class 2
|
NDM
|
| §888.3040 |
Accessory, System, External Fixator, Containing Antimicrobial Agent
|
Class 2
|
NJA
|
| §888.3040 |
Laparoscopic Bone Anchor Urethropexy Instrument Kit
|
Class 2
|
NWN
|
| §888.3045 |
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
|
Class 2
|
MBP
|
| §888.3045 |
Filler, Bone Void, Calcium Compound
|
Class 2
|
MQV
|
| §888.3045 |
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
|
Class 2
|
OIS
|
| §888.3050 |
Appliance, Fixation, Spinal Interlaminal
|
Class 2
|
KWP
|
| §888.3050 |
Accessories, Fixation, Spinal Interlaminal
|
Class 2
|
LYP
|
| §888.3050 |
Orthosis, Spine, Plate, Laminoplasty, Metal
|
Class 2
|
NQW
|
| §888.3060 |
Implant, Fixation Device, Spinal
|
Class 2
|
JDN
|
| §888.3060 |
Appliance, Fixation, Spinal Intervertebral Body
|
Class 2
|
KWQ
|
| §888.3060 |
Spinal Vertebral Body Replacement Device
|
Class 2
|
MQP
|
| §888.3060 |
Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
|
Class 2
|
OJB
|
| §888.3060 |
Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh
|
Class 2
|
OJM
|
| §888.3070 |
Orthosis, Spondylolisthesis Spinal Fixation
|
Class 2
|
MNH
|
| §888.3070 |
Orthosis, Spinal Pedicle Fixation
|
Class 2
|
MNI
|
| §888.3070 |
Thoracolumbosacral Pedicle Screw System
|
Class 2
|
NKB
|
| §888.3070 |
Posterior Metal/Polymer Spinal System, Fusion
|
Class 2
|
NQP
|
| §888.3080 |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
Class 2
|
MAX
|
| §888.3080 |
Intervertebral Fusion Device With Bone Graft, Cervical
|
Class 2
|
ODP
|
| §888.3100 |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite
|
Class 2
|
KMD
|
| §888.3110 |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
|
Class 2
|
HSN
|
| §888.3120 |
Prosthesis, Ankle, Cemented, Non-Constrained
|
Class 3
|
KXC
|
| §888.3150 |
Prosthesis, Elbow, Constrained, Cemented
|
Class 2
|
JDC
|
| §888.3160 |
Prosthesis, Elbow, Semi-Constrained, Cemented
|
Class 2
|
JDB
|
| §888.3170 |
Prosthesis, Elbow, Hemi-, Radial, Polymer
|
Class 2
|
KWI
|
| §888.3180 |
Prosthesis, Elbow, Hemi-, Humeral, Metal
|
Class 3
|
KWJ
|
| §888.3200 |
Prosthesis, Finger, Constrained, Metal, Uncemented
|
Class 3
|
KWE
|
| §888.3210 |
Prosthesis, Finger, Constrained, Metal, Cemented
|
Class 3
|
LBC
|
| §888.3220 |
Prosthesis, Finger, Constrained, Metal/Polymer
|
Class 3
|
KWG
|
| §888.3230 |
Prosthesis, Finger, Polymer
|
Class 2
|
KWF
|
| §888.3230 |
Prosthesis, Finger, Constrained, Polymer
|
Class 2
|
KYJ
|
| §888.3300 |
Prosthesis, Hip, Constrained, Metal
|
Class 3
|
KXD
|
| §888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
|
Class 2
|
KWZ
|
| §888.3320 |
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
|
Class 3
|
JDL
|
| §888.3320 |
Spacer, Cement
|
Class 3
|
LTO
|
| §888.3330 |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
Class 3
|
KWA
|
| §888.3340 |
Prosthesis, Hip, Semi-Constrained, Composite/Metal
|
Class 2
|
KMC
|
| §888.3350 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
|
Class 2
|
JDI
|
| §888.3350 |
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
|
Class 2
|
OQH
|
| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
Class 2
|
LZO
|
| §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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
|
Class 2
|
MEH
|
| §888.3353 |
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
|
Class 2
|
OQI
|
| §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
|
| §888.3358 |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
|
Class 2
|
OQG
|
| §888.3360 |
Prosthesis, Upper Femoral
|
Class 2
|
JDD
|
| §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, Semi-Constrained, Metal/Polymer, Uncemented
|
Class 2
|
LWJ
|
| §888.3360 |
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
|
Class 2
|
LZY
|
| §888.3370 |
Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal
|
Class 3
|
KWB
|
| §888.3390 |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
|
Class 2
|
KWY
|
| §888.3400 |
Prosthesis, Hip, Femoral, Resurfacing
|
Class 2
|
KXA
|
| §888.3410 |
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer
|
Class 3
|
KXB
|
| §888.3410 |
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented
|
Class 3
|
OCG
|
| §888.3480 |
Prosthesis, Knee, Hinged (Metal-Metal)
|
Class 3
|
HRZ
|
| §888.3480 |
Metal Cemented Constrained Femorotibial Knee Prosthesis
|
Class 3
|
KRN
|
| §888.3490 |
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
|
Class 2
|
KMB
|
| §888.3490 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented
|
Class 2
|
KTX
|
| §888.3500 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
|
Class 2
|
KYK
|
| §888.3510 |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
|
Class 2
|
KRO
|
| §888.3520 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
|
Class 2
|
HSX
|
| §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
|
| §888.3535 |
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
|
Class 2
|
NJD
|
| §888.3540 |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
|
Class 2
|
KRR
|
| §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
|
| §888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
Class 2
|
JWH
|
| §888.3560 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
|
Class 2
|
MBV
|
| §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
|
| §888.3565 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
|
Class 2
|
MBH
|
| §888.3570 |
Prosthesis, Knee, Hemi-, Femoral (Uncemented)
|
Class 3
|
KRS
|
| §888.3580 |
Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
|
Class 2
|
HTG
|
| §888.3590 |
Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
|
Class 2
|
HSH
|
| §888.3640 |
Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented
|
Class 3
|
KWR
|
| §888.3650 |
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
|
Class 2
|
KWT
|
| §888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
|
Class 2
|
KWS
|
| §888.3670 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
|
Class 2
|
MBF
|
| §888.3680 |
Metallic Cemented Glenoid Hemi-Shoulder Prosthesis
|
Class 3
|
KYM
|
| §888.3690 |
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
|
Class 2
|
HSD
|
| §888.3720 |
Prosthesis, Toe, Constrained, Polymer
|
Class 2
|
KWH
|
| §888.3730 |
Prosthesis, Toe, Hemi-, Phalangeal
|
Class 2
|
KWD
|
| §888.3750 |
Prosthesis, Wrist, Carpal Lunate
|
Class 2
|
KWN
|
| §888.3760 |
Prosthesis, Wrist, Carpal Scaphoid
|
Class 2
|
KWO
|
| §888.3770 |
Prosthesis, Wrist, Carpal Trapezium
|
Class 2
|
KYI
|
| §888.3780 |
Prosthesis, Wrist, Constrained, Polymer
|
Class 2
|
KIG
|
| §888.3790 |
Prosthesis, Wrist, Constrained, Metal
|
Class 3
|
KYN
|
| §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
|
| §888.3810 |
Prosthesis, Wrist, Hemi-, Ulnar
|
Class 2
|
KXE
|
| §888.4150 |
Caliper
|
Class 1
|
KTZ
|
| §888.4200 |
Dispenser, Cement
|
Class 1
|
KIH
|
| §888.4200 |
Injector, Vertebroplasty (Does Not Contain Cement)
|
Class 1
|
OAR
|
| §888.4210 |
Mixer, Cement, For Clinical Use
|
Class 1
|
JDZ
|
| §888.4220 |
Evacuator, Vapor, Cement Monomer
|
Class 1
|
JDY
|
| §888.4230 |
Tube, Cement Ventilation
|
Class 1
|
KII
|
| §888.4300 |
Gauge, Depth
|
Class 1
|
HTJ
|
| §888.4540 |
Scissors, Orthopedic, Surgical
|
Class 1
|
HRR
|
| §888.4540 |
Stripper, Surgical
|
Class 1
|
HRT
|
| §888.4540 |
Reamer
|
Class 1
|
HTO
|
| §888.4540 |
File
|
Class 1
|
HTP
|
| §888.4540 |
Broach
|
Class 1
|
HTQ
|
| §888.4540 |
Knife, Orthopedic
|
Class 1
|
HTS
|
| §888.4540 |
Burr, Orthopedic
|
Class 1
|
HTT
|
| §888.4540 |
Bit, Drill
|
Class 1
|
HTW
|
| §888.4540 |
Rongeur
|
Class 1
|
HTX
|
| §888.4540 |
Impactor
|
Class 1
|
HWA
|
| §888.4540 |
Extractor
|
Class 1
|
HWB
|
| §888.4540 |
Starter, Bone Screw
|
Class 1
|
HWD
|
| §888.4540 |
Corkscrew
|
Class 1
|
HWI
|
| §888.4540 |
Awl
|
Class 1
|
HWJ
|
| §888.4540 |
Trephine
|
Class 1
|
HWK
|
| §888.4540 |
Set, Hollow Mill
|
Class 1
|
HWL
|
| §888.4540 |
Instrument, Compression
|
Class 1
|
HWN
|
| §888.4540 |
Skid, Bone
|
Class 1
|
HWO
|
| §888.4540 |
Punch, Femoral Neck
|
Class 1
|
HWP
|
| §888.4540 |
Passer
|
Class 1
|
HWQ
|
| §888.4540 |
Driver, Prosthesis
|
Class 1
|
HWR
|
| §888.4540 |
Countersink
|
Class 1
|
HWW
|
| §888.4540 |
Tap, Bone
|
Class 1
|
HWX
|
| §888.4540 |
Probe
|
Class 1
|
HXB
|
| §888.4540 |
Wrench
|
Class 1
|
HXC
|
| §888.4540 |
Fork
|
Class 1
|
HXE
|
| §888.4540 |
Tamp
|
Class 1
|
HXG
|
| §888.4540 |
Passer, Wire, Orthopedic
|
Class 1
|
HXI
|
| §888.4540 |
Staple Driver
|
Class 1
|
HXJ
|
| §888.4540 |
Holder, Needle; Orthopedic
|
Class 1
|
HXK
|
| §888.4540 |
Applier, Cerclage
|
Class 1
|
HXN
|
| §888.4540 |
Pusher, Socket
|
Class 1
|
HXO
|
| §888.4540 |
Instrument, Bending Or Contouring
|
Class 1
|
HXP
|
| §888.4540 |
Crimper, Pin
|
Class 1
|
HXQ
|
| §888.4540 |
Twister, Wire
|
Class 1
|
HXS
|
| §888.4540 |
Bender
|
Class 1
|
HXW
|
| §888.4540 |
Screwdriver
|
Class 1
|
HXX
|
| §888.4540 |
Brace, Drill
|
Class 1
|
HXY
|
| §888.4540 |
Cutter, Wire
|
Class 1
|
HXZ
|
| §888.4540 |
Positioner, Socket
|
Class 1
|
KIL
|
| §888.4540 |
Orthopedic Manual Surgical Instrument
|
Class 1
|
LXH
|
| §888.4540 |
Bone Mill
|
Class 1
|
LYS
|
| §888.4540 |
Spinal Channeling Instrument, Vertebroplasty
|
Class 1
|
OCJ
|
| §888.4580 |
Instrument, Surgical, Sonic And Accessory/Attachment
|
Class 2
|
JDX
|
| §888.4580 |
System, Cement Removal Extraction
|
Class 2
|
LZV
|
| §888.4600 |
Protractor
|
Class 1
|
HTH
|
| §888.4800 |
Template
|
Class 1
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HWT
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Relevant FDA Guidance and/or Supportive Publications*
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
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