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510(k) K012762

MJS POSTERIOR STABILIZED KNEE SYSTEM by Osteoimplant Technology, Inc. — Product Code HRY

K012762 is an FDA 510(k) premarket notification submitted by Osteoimplant Technology, Inc. for the device "MJS POSTERIOR STABILIZED KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 11, 2001. The device falls under product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3530. Osteoimplant Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2001
Date Received
August 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3530
Review Panel
OR
Submission Type

Other clearances by Osteoimplant Technology, Inc.

  • K040685 — Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED (January 25, 2005)
  • K041443 — OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM (November 16, 2004)
  • K040225 — OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM (May 6, 2004)
  • K032729 — Z-SERIES MODULAR TOTAL HIP SYSTEM (December 3, 2003)
  • K030608 — OTI BONE CEMENT PLUG (June 12, 2003)
  • K022779 — OTI UNICONDULAR INTERPOSITIONAL SPACER (November 20, 2002)
  • K021822 — R120 MODULAR TOTAL HIP SYSTEM (July 23, 2002)
  • K011774 — R120 MODULAR TOTAL HIP SYSTEM (September 5, 2001)
  • K003316 — OTI CERAMIC FEMORAL HEAD SYSTEM (January 19, 2001)
  • K003199 — TRIAD II MODULAR TOTAL HIP SYSTEM (January 10, 2001)

Other clearances for product code HRY

  • K193549 — SIGMA High Performance (HP) Partial Knee System (April 16, 2020)
  • K190633 — NanoOrtho NanoKnee® System (December 20, 2019)
  • K152631 — MPO Total Knee Systems MR Labeling (March 23, 2016)
  • K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM (March 20, 2015)
  • K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) (March 28, 2014)
  • K131167 — UNIVATION (October 17, 2013)
  • K122277 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) (October 22, 2012)
  • K110415 — SIGNATURE PLANNER / SIGNATURE GUIDES (May 16, 2011)
  • K100973 — EVOLUTION UNICONDYLAR KNEE SYSTEM (August 10, 2010)
  • K082567 — STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION (October 3, 2008)

FDA data resources