Panels › Orthopedic › Product code HSN · Class 2
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Regulation 888.3110
2510(k)s in 12 months (69 all time)
0recalls in 12 months (47 all time)
47recalls that name a 510(k)
Top companies in HSN
| Company | 510(k)s | Recalls |
|---|---|---|
| Integra LifeSciences Corporation | 1 | 28 |
| Wrightmedicaltechnologyinc | 21 | 0 |
| Exactech, Inc. | 4 | 5 |
| Wright Medical Technology Inc | 0 | 9 |
| Paragon 28, Inc. | 8 | 0 |
| Restor3D | 5 | 0 |
| Depuy, Inc. | 4 | 0 |
| In2bones Sas | 4 | 0 |
| Zimmer, Inc. | 1 | 3 |
| Tornier | 2 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 4, 2013 | K123059 | INBONE ( I AND II) TOTAL ANKLE SYSTEMS Wrightmedicaltechnologyinc | HSN |
| Oct 31, 2012 | K122395 | DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS DePuy Orthopaedics, Inc. | HSN |
| Aug 24, 2012 | K120906 | ZIMMER TRABECULAR METAL TOTAL ANKLE Zimmer, Inc. | HSN |
| Dec 16, 2011 | K110360 | PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES Wrightmedicaltechnologyinc | HSN |
| Dec 14, 2010 | K103374 | INBONE TOTAL ANKLE SYSTEM MODEL 200347902 Wrightmedicaltechnologyinc | HSN |
| Aug 26, 2010 | K100886 | INBONE II TOTAL ANKLE REPLACEMENT Wrightmedicaltechnologyinc | HSN |
| Mar 17, 2009 | K090076 | SALTO TALARIS TOTAL ANKLE PROSTHESIS Tornier, FR | HSN |
| Nov 22, 2006 | K061749 | ECLIPSE TOTAL ANKLE IMPLANT Kinetikos Medical, Inc. | HSN |
| Nov 13, 2006 | K060544 | SALTO TALARIS TOTAL ANKLE PROSTHESIS Tornier, FR | HSN |
| Mar 31, 2006 | K053569 | AGILITY LP TOTAL ANKLE PROSTHESIS DePuy Orthopaedics, Inc. | HSN |
| Nov 15, 2005 | K051023 | TOPEZ TOTAL ANKLE REPLACEMENT Topez Orthopedics, Inc. | HSN |
| May 20, 2002 | K020541 | AGILITY ANKLE REVISION PROSTHESIS Depuy, Inc. | HSN |
| Dec 17, 1992 | K920802 | ALVINE TOTAL ANKLE Depuy, Inc. | HSN |
| Feb 19, 1981 | K803167 | BRIGHAM TOTAL ANKLE PROSTHESIS Howmedica Corp. | HSN |
| Apr 2, 1980 | K800530 | SCHLEIN TRI-SURFACE ANKLE Orthopedic Equipment Co., Inc. | HSN |
| Mar 14, 1977 | K770421 | COMPONENTS, ANKLE, TRIAL, CON-AXIAL Depuy, Inc. | HSN |
| Mar 14, 1977 | K770420 | FORCEPS, ANKLE INSERTING, CON-AXIAL Depuy, Inc. | HSN |
| Nov 23, 1976 | K761021 | ANKLE INSTRUMENTS (FREEMAN-SWANSON) Medishield, Inc. | HSN |
| Nov 23, 1976 | K761020 | ANKLE (FREEMAN-SWANSON) Medishield, Inc. | HSN |
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