Home › Device types › NPJ
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
FDA product code NPJ · Class 2 · Orthopedic
2,213
Registered devices
1,136
Adverse events
8
Recalls
12
510(k) clearances
Devices with this code
INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.RESTORIS ESYNTIAL — MAKO SURGICAL CORP.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.RESTORIS ESYNTIAL — MAKO SURGICAL CORP.RESTORIS — MAKO SURGICAL CORP.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.RESTORIS ESYNTIAL — MAKO SURGICAL CORP.RESTORIS ESYNTIAL — MAKO SURGICAL CORP.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.RESTORIS ESYNTIAL — MAKO SURGICAL CORP.INSTRUMENT — Howmedica Osteonics Corp.RESTORIS ESYNTIAL — MAKO SURGICAL CORP.INSTRUMENT — Howmedica Osteonics Corp.RESTORIS — MAKO SURGICAL CORP.SIGMA — DEPUY (IRELAND)
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-01-19 | Mako Surgical Corporation | Possible hinge pin disassociation from the Mako Onlay Insert Extractor. |
| 2016-01-15 | Mako Surgical Corporation | Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier. |
| 2015-08-31 | ConforMIS, Inc. | May contain small amounts of ethylene glycol residue |
| 2015-08-31 | ConforMIS, Inc. | May contain small amounts of ethylene glycol residue |
| 2015-08-31 | ConforMIS, Inc. | May contain small amounts of ethylene glycol residue |
| 2014-01-09 | Mako Surgical Corporation | The product may be mislabeled and could result in the incorrect implant being used. |
| 2011-08-17 | Stryker Howmedica Osteonics Corp. | Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices. |
| 2004-10-27 | Stryker Howmedica Osteonics Corp. | The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineate |
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