FDA-recognized standard · Orthopedic
ASTM F983: Standard Practice for Permanent Marking of Orthopaedic Implant Components
Yes. FDA recognizes ASTM F983-24 as recognition 11-424, entered 2025-12-22. FDA also lists ASTM F983-86 (Reapproved 2018) (recognition 11-197, transition period ending 2027-12-19).
Recognized editions of ASTM F983
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-424 | ASTM F983-24 | 2025-12-22 | Complete | — |
| 11-197 | ASTM F983-86 (Reapproved 2018) | 2018-09-17 | Complete | 2027-12-19 |
Regulations
FDA lists these classification regulations against ASTM F983: 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.
Product codes that cite ASTM F983
137 FDA product codes cite ASTM F983, including HAS, HRS, HRY, HRZ, HSB.
- HAS
- HRS Plate, Fixation, Bone
- 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
- HTN Washer, Bolt Nut
- HTY Pin, Fixation, Smooth
- HWC Screw, Fixation, Bone
- HXA
- 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
- JEC
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- JWI
- JWJ
- KIG
- KMB
- KMC
- KMD
- KRN
- KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- KRP
- KRQ
- KRR
- KRS
- KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KTW
- KTX
- KWA
- KWB
- KWD
- KWE
- KWF
- KWG
- KWH
- KWI
- KWJ
- KWK
- KWL Prosthesis, Hip, Hemi-, Femoral, Metal
- KWM
- KWN
- KWO
- KWP
- KWQ Appliance, Fixation, Spinal Intervertebral Body
- KWR
- KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWZ
- KXA
- KXB
- KXC
- KXD
- KXE
- KYI
- KYJ
- KYK
- KYM
- KYN
- LBC
- LGE
- LOD Bone Cement
- LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
The first 80 of 137 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.