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

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

21 CFR 888.3660 / Orthopedic
FDA source (opens on fda.gov)

KWS is the FDA product code for Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, a class II device type, regulated under 21 CFR 888.3660. As of , FDA records hold 191 510(k) clearances under this code, the most recent dated , and 152 recalls.

Classification record

Product code
KWS
Device name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Regulation
21 CFR 888.3660
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
191
Ingested recalls
153

Clearances, product code KWS

By decision year
191 clearances under product code KWS with a decision year between 1980 and 2026, 2013 the highest year at 12.
Show the numbers
510(k) clearances under FDA product code KWS by decision year
YearClearances
19801
19831
19852
19862
19871
19883
19892
19903
19912
19931
19941
19954
19966
19971
19982
19997
20008
20017
20022
20034
20046
20053
20066
20072
20084
20094
20107
201111
20127
201312
20147
20158
201610
20177
20184
20199
20203
20215
20225
20234
20242
20253
20262

Applicants with the most clearances

Product code KWS
Applicants holding the most 510(k) clearances under product code KWS
ApplicantClearances
TORNIER Inc.24
Arthrex GmbH15
Zimmer GmbH11
Smith & Nephew, Inc.11
Depuy Orthopaedics Inc.9
Encore Medical, LP9
Exactech, Inc.8
Lima Corporate S.p.A.8
Tornier S.A.S.8
Osteonics Corp.7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 185 companies shown, in name order