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

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

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

PKC is the FDA product code for Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained, a class II device type, regulated under 21 CFR 888.3660. FDA's definition for this code reads: "Replacement of the humeral head for total anatomic shoulder arthroplasty". As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
PKC
Device name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
FDA definition
Replacement of the humeral head for total anatomic shoulder arthroplasty
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
20
Ingested recalls
3

Clearances, product code PKC

By decision year
20 clearances under product code PKC with a decision year between 2015 and 2026, 2020 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code PKC by decision year
YearClearances
20151
20171
20181
20191
20204
20212
20223
20231
20243
20251
20262

Applicants with the most clearances

Product code PKC
Applicants holding the most 510(k) clearances under product code PKC
ApplicantClearances
Arthrex GmbH2
Exactech, Inc.2
Smith & Nephew, Inc.2
TORNIER Inc.2
Zimmer GmbH2
Biomet Manufacturing Corp1
Depuy Ireland UC1
Depuy (Ireland)1
Encore Medical, LP1
Fx Shoulder Solutions Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 60 companies shown, in name order