510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JDIClass II

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

21 CFR 888.3350 / Orthopedic
FDA source (opens on fda.gov)

JDI is the FDA product code for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a class II device type, regulated under 21 CFR 888.3350. As of , FDA records hold 565 510(k) clearances under this code, the most recent dated , and 255 recalls.

Classification record

Product code
JDI
Device name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Regulation
21 CFR 888.3350
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
565
Ingested recalls
255

Clearances, product code JDI

By decision year
565 clearances under product code JDI with a decision year between 1977 and 2026, 1996 the highest year at 37.
Show the numbers
510(k) clearances under FDA product code JDI by decision year
YearClearances
19771
19783
19791
19804
19819
19826
198325
198411
198521
198610
198726
198824
198915
199036
199136
199222
199322
199430
199528
199637
199727
199821
199915
200017
200119
200215
200311
20044
200511
20062
20073
20085
20093
20112
20124
20133
20143
20153
20164
20171
20181
20192
20207
20213
20223
20232
20243
20251
20263

Applicants with the most clearances

Product code JDI
Applicants holding the most 510(k) clearances under product code JDI
ApplicantClearances
Zimmer GmbH79
Howmedica Corp.43
Depuy, Inc.37
Osteonics Corp.29
Intermedics Orthopedics21
Howmedica Osteonics Corp17
Kirschner Medical Corp.17
Orthomet, Inc.16
Encore Orthopedics, Inc.13
Depuy Orthopaedics Inc.12

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 182 companies shown, in name order