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510(k) K020741

UNICONDYLAR KNEE by Encore Orthopedics, Inc. — Product Code HRY

K020741 is an FDA 510(k) premarket notification submitted by Encore Orthopedics, Inc. for the device "UNICONDYLAR KNEE". The FDA issued a decision of Substantially Equivalent on June 4, 2002. 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. Encore Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2002
Date Received
March 6, 2002
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 Encore Orthopedics, Inc.

  • K032905 — 3DKNEE POROUS COATED FEMORAL COMPONENT (July 6, 2004)
  • K020114 — 3D KNEE (July 12, 2002)
  • K020236 — MODIFICATION TO PASS SPINAL SYSTEM (February 14, 2002)
  • K020170 — KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP (February 11, 2002)
  • K013490 — CEMENTED CALCAR HIP SYSTEM (January 17, 2002)
  • K013442 — PASS SPINAL SYSTEM (January 15, 2002)
  • K003324 — PLASMA SPRAYED SHOULDER (December 6, 2001)
  • K013431 — PASS SPINAL SYSTEM (November 15, 2001)
  • K013191 — PASS SPINAL SYSTEM (October 24, 2001)
  • K011856 — RADIOGRAPHIC MARKERS (August 22, 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