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

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

21 CFR 888.3358 / Orthopedic
FDA source (opens on fda.gov)

LPH is the FDA product code for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, a class II device type, regulated under 21 CFR 888.3358. As of , FDA records hold 564 510(k) clearances under this code, the most recent dated , and 297 recalls.

Classification record

Product code
LPH
Device name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation
21 CFR 888.3358
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
297

Clearances, product code LPH

By decision year
565 clearances under product code LPH with a decision year between 1984 and 2026, 1997 the highest year at 34.
Show the numbers
510(k) clearances under FDA product code LPH by decision year
YearClearances
19843
19852
19864
19901
19923
19936
199428
199526
199625
199734
199818
199921
200032
200119
200222
200320
200418
200513
200624
200710
200810
20093
201015
201116
201225
201311
201420
201518
201610
201712
20189
201922
20207
20218
202214
202310
20246
202512
20268

Applicants with the most clearances

Product code LPH
Applicants holding the most 510(k) clearances under product code LPH
ApplicantClearances
Zimmer GmbH90
Depuy Orthopaedics Inc.33
Smith & Nephew, Inc.32
Depuy, Inc.21
Exactech, Inc.19
Howmedica Corp.18
Encore Orthopedics, Inc.16
Howmedica Osteonics Corp16
United Orthopedic Corp.15
Encore Medical, LP13

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 223 companies shown, in name order