Panels › Orthopedic › Product code HSX · Class 2
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Regulation 888.3520
3510(k)s in 12 months (115 all time)
0recalls in 12 months (104 all time)
100recalls that name a 510(k)
Top companies in HSX
| Company | 510(k)s | Recalls |
|---|---|---|
| Smith & Nephew, Inc. | 13 | 54 |
| Linkbio Corp. | 0 | 32 |
| Conformis, Inc. | 8 | 3 |
| Zimmer, Inc. | 9 | 2 |
| Bodycad Laboratories, Inc. | 7 | 0 |
| Mako Surgical Corp. | 6 | 0 |
| Zimmer Biomet | 1 | 5 |
| Depuy, Inc. | 5 | 0 |
| Howmedica Corp. | 5 | 0 |
| Medacta International S.A. | 5 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2014 | Blue Belt Technologies MN Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis. Terminated |
HSX | K123380 |
| Oct 25, 2013 | Zimmer, Inc. Zimmer Unicompartmental Knee Femoral Component.
Indicated for patients with painful and/or disabling knee joint. Terminated |
HSX | K033363 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422242, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | None listed |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL BASEPLATE RIGHT MEDIAL/ LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422231, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | None listed |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933303, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933302, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933301, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933300, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933299, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933298, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933297, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933296, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422268, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422267, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422266, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422265, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422264, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422263, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422262, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422261, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422258, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422257, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422256, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422255, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422254, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422253, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422252, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422251, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422248, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422247, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422246, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422245, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422244, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422243, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422241, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 55 MM, M/L 32 MM, REF 71422236, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422235, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 49 MM, M/L 29 MM, REF 71422234, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422233, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 42 MM, M/L 25 MM, REF 71422232, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 55 MM, M/L 32 MM, REF 71422226, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422225, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 49 MM, M/L 29 MM, REF 71422224, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 46MM, M/L 27 MM, REF 71422223, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 42 MM, M/L 25 MM, REF 71422222, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Mar 3, 2010 | Smith & Nephew Inc JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDICAL/TIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422221, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 Terminated |
HSX | K052265 |
| Dec 22, 2009 | Zimmer Inc. Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01. Terminated |
HSX | K862632 |
| Nov 20, 2009 | Stelkast Co Stelkast Unicondylar Knee Femoral Component SC2462-1.
Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee impl Terminated |
HSX | K032824 |
| Jul 15, 2009 | Conformis Inc ConforMIS iUni ( Unicondylar Knee System iUni Right Lateral Implant Kit Product Code: M57220600040.
For cemented use only. System consists of femoral and tibial components. The femoral component is Terminated |
HSX | K043570 K063432 +1 |
| Jul 15, 2009 | Conformis Inc ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit Product Code : M57220600020.
For cemented use only. System consists of femoral and tibial components. The femoral component Terminated |
HSX | K043570 K063432 +1 |
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