FDA-recognized standard · Orthopedic
ISO 14243-5: Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint
Yes. FDA recognizes ISO 14243-5 First edition 2019-05 as recognition 11-361, entered 2019-12-23.
Recognized editions of ISO 14243-5
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-361 | ISO 14243-5 First edition 2019-05 | 2019-12-23 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 14243-5: 21 CFR 888.3540, 21 CFR 888.3550, 21 CFR 888.3560, 21 CFR 888.3565, 21 CFR 888.3580.
Product codes that cite ISO 14243-5
11 FDA product codes cite ISO 14243-5, including HTG, JWH, KRP, KRR, LXY.
- HTG
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KRP
- KRR
- LXY
- MBD
- MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- MBV
- NJL
- NPJ
- OIY
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.