510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
KWAClass III

Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

21 CFR 888.3330 / Orthopedic
FDA source (opens on fda.gov)

KWA is the FDA product code for Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), a class III device type, regulated under 21 CFR 888.3330. As of , FDA records hold 114 510(k) clearances under this code, the most recent dated , and 203 recalls.

Classification record

Product code
KWA
Device name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation
21 CFR 888.3330
Device class
Class III
Review panel
Orthopedic
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
114
Ingested recalls
203

Clearances, product code KWA

By decision year
114 clearances under product code KWA with a decision year between 1978 and 2012, 1985 the highest year at 13.
Show the numbers
510(k) clearances under FDA product code KWA by decision year
YearClearances
19781
198513
19861
19876
19883
19892
19903
19931
19992
20006
20013
20022
20031
20046
20058
200611
20078
20089
20097
20106
201111
20124

Applicants with the most clearances

Product code KWA
Applicants holding the most 510(k) clearances under product code KWA
ApplicantClearances
Wrightmedicaltechnologyinc26
Zimmer GmbH20
Biomet Manufacturing Corp14
Depuy Orthopaedics Inc.12
Encore Medical, LP6
Protek, Inc.4
Advanced Biosearch Assn.3
Allo Pro Corp.3
Osteonics Corp.3
Sulzer Orthopedics, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 44 companies shown, in name order