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

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

21 CFR 888.3110 / Orthopedic
FDA source (opens on fda.gov)

HSN is the FDA product code for Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer, a class II device type, regulated under 21 CFR 888.3110. As of , FDA records hold 68 510(k) clearances under this code, the most recent dated , and 47 recalls.

Classification record

Product code
HSN
Device name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3110
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
68
Ingested recalls
47

Clearances, product code HSN

By decision year
68 clearances under product code HSN with a decision year between 1976 and 2026, 2024 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code HSN by decision year
YearClearances
19762
19772
19801
19811
19921
20021
20051
20063
20091
20102
20111
20122
20134
20142
20153
20163
20174
20184
20192
20206
20214
20221
20236
20247
20253
20261

Applicants with the most clearances

Product code HSN
Applicants holding the most 510(k) clearances under product code HSN
ApplicantClearances
Wrightmedicaltechnologyinc21
Paragon 287
restor3d, Inc.5
Exactech, Inc.4
In2Bones SAS4
Wright Medical Technology, Inc. (Stryker)3
Ascension Orthopedics, Inc.2
Depuy Orthopaedics Inc.2
Depuy, Inc.2
Depuy, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 76 companies shown, in name order