FDA-recognized standard · Orthopedic
ASTM F565: Standard Practice for Care and Handling of Orthopedic Implants and Instruments
Yes. FDA recognizes ASTM F565-21 as recognition 11-425, entered 2025-12-22. FDA also lists ASTM F565-04 (Reapproved 2018) (recognition 11-199, transition period ending 2027-12-19).
Recognized editions of ASTM F565
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-425 | ASTM F565-21 | 2025-12-22 | Complete | — |
| 11-199 | ASTM F565-04 (Reapproved 2018) | 2018-09-17 | Complete | 2027-12-19 |
Regulations
FDA lists these classification regulations against ASTM F565: 21 CFR 882.4650, 21 CFR 888.3000, 21 CFR 888.3010, 21 CFR 888.3015, 21 CFR 888.3020, 21 CFR 888.3025, 21 CFR 888.3027, 21 CFR 888.3030, 21 CFR 888.3040, 21 CFR 888.3045, 21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070, 21 CFR 888.3080, 21 CFR 888.3100, 21 CFR 888.3110, 21 CFR 888.3120, 21 CFR 888.3150, 21 CFR 888.3160, 21 CFR 888.3170, 21 CFR 888.3180, 21 CFR 888.3200, 21 CFR 888.3210, 21 CFR 888.3220, 21 CFR 888.3230, 21 CFR 888.3300, 21 CFR 888.3310, 21 CFR 888.3320, 21 CFR 888.3330, 21 CFR 888.3340, 21 CFR 888.3350, 21 CFR 888.3353, 21 CFR 888.3358, 21 CFR 888.3360, 21 CFR 888.3370, 21 CFR 888.3390, 21 CFR 888.3400, 21 CFR 888.3410, 21 CFR 888.3480, 21 CFR 888.3490, 21 CFR 888.3500, 21 CFR 888.3510, 21 CFR 888.3520, 21 CFR 888.3530, 21 CFR 888.3535, 21 CFR 888.3540, 21 CFR 888.3550, 21 CFR 888.3560, 21 CFR 888.3565, 21 CFR 888.3570, 21 CFR 888.3580, 21 CFR 888.3590, 21 CFR 888.3640, 21 CFR 888.3650, 21 CFR 888.3660, 21 CFR 888.3670, 21 CFR 888.3680, 21 CFR 888.3690, 21 CFR 888.3720, 21 CFR 888.3730, 21 CFR 888.3750, 21 CFR 888.3760, 21 CFR 888.3770, 21 CFR 888.3780, 21 CFR 888.3790, 21 CFR 888.3800, 21 CFR 888.3810, 21 CFR 888.4150, 21 CFR 888.4200, 21 CFR 888.4210, 21 CFR 888.4220, 21 CFR 888.4230, 21 CFR 888.4300, 21 CFR 888.4540, 21 CFR 888.4580, 21 CFR 888.4600, 21 CFR 888.4800.
Product codes that cite ASTM F565
191 FDA product codes cite ASTM F565, including HAS, HRR, HRS, HRT, HRY.
- HAS
- HRR
- HRS Plate, Fixation, Bone
- HRT
- HRY
- HRZ
- HSB Rod, Fixation, Intramedullary And Accessories
- HSD
- HSH
- HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HTG
- HTH
- HTJ
- HTN Washer, Bolt Nut
- HTO
- HTP
- HTQ
- HTS
- HTT
- HTW
- HTX
- HTY Pin, Fixation, Smooth
- HWA
- HWB
- HWC Screw, Fixation, Bone
- HWD
- HWI
- HWJ
- HWK
- HWL
- HWN
- HWO
- HWP
- HWQ
- HWR
- HWT
- HWW
- HWX
- HXA
- HXB
- HXC
- HXE
- HXG
- HXI
- HXJ
- HXK
- HXN
- HXO
- HXP
- HXQ
- HXS
- HXW
- HXX
- HXY
- HXZ
- JDB
- JDC
- JDD
- JDG
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- JDL
- JDN
- JDO
- JDP
- JDQ Cerclage, Fixation
- JDR Staple, Fixation, Bone
- JDS
- JDT
- JDW Pin, Fixation, Threaded
- JDX
- JDY
- JDZ
- JEC
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- JWI
- JWJ
- KIG
- KIH
- KII
The first 80 of 191 are shown.
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.