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510(k) K983657

OSTEONICS SERIES 7000 AD TIBIAL TRAY by Osteonics Corp. — Product Code HRY

K983657 is an FDA 510(k) premarket notification submitted by Osteonics Corp. for the device "OSTEONICS SERIES 7000 AD TIBIAL TRAY". The FDA issued a decision of Substantially Equivalent on April 6, 2000. 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. Osteonics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2000
Date Received
October 19, 1998
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 Osteonics Corp.

  • K980070 — OSTEONICS HA-COATED DEVICES (July 23, 1999)
  • K984375 — OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY (April 30, 1999)
  • K982798 — OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM (March 25, 1999)
  • K984585 — OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE (February 24, 1999)
  • K990203 — OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS (February 18, 1999)
  • K990158 — OSTEONICS COMBINATION SCREW RING/BLOCKER (February 1, 1999)
  • K984302 — OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS (December 18, 1998)
  • K984353 — OSTEO 9MM IC TIBIAL NAIL (December 16, 1998)
  • K983502 — OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM (December 16, 1998)
  • K983382 — OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM (December 11, 1998)

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