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

Shoulder Prosthesis, Reverse Configuration

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

PHX is the FDA product code for Shoulder Prosthesis, Reverse Configuration, a class II device type, regulated under 21 CFR 888.3660. FDA's definition for this code reads: "Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint". As of , FDA records hold 205 510(k) clearances under this code, the most recent dated , and 68 recalls.

Classification record

Product code
PHX
Device name
Shoulder Prosthesis, Reverse Configuration
FDA definition
Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
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
205
Ingested recalls
68

Clearances, product code PHX

By decision year
205 clearances under product code PHX with a decision year between 2003 and 2026, 2021 the highest year at 21.
Show the numbers
510(k) clearances under FDA product code PHX by decision year
YearClearances
20031
20042
20056
20064
20075
20086
20091
20108
201112
201212
20138
201412
20154
20164
201711
201814
20199
202013
202121
20229
20239
20249
20259
202616

Applicants with the most clearances

Product code PHX
Applicants holding the most 510(k) clearances under product code PHX
ApplicantClearances
Exactech, Inc.21
Encore Medical, LP18
TORNIER Inc.18
Biomet Manufacturing Corp15
Zimmer GmbH14
Medacta International SA13
Arthrex GmbH11
Lima Corporate S.p.A.11
Fx Shoulder USA, Inc.9
Depuy Ireland UC8

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 161 companies shown, in name order