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510(k) K081293

UNIVATION UNICONDYLAR KNEE SYSTEM by Aesculap Implant Systems, Inc. — Product Code HRY

K081293 is an FDA 510(k) premarket notification submitted by Aesculap Implant Systems, Inc. for the device "UNIVATION UNICONDYLAR KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 22, 2008. 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. Aesculap Implant Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2008
Date Received
May 7, 2008
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 Aesculap Implant Systems, Inc.

  • K213871 — Ennovate Cervical Spinal and Occiput System (July 1, 2022)
  • K210963 — ENNOVATE Spinal System (July 19, 2021)
  • K180433 — ENNOVATE® (April 26, 2018)
  • K162134 — ENNOVATE Spinal System (December 14, 2016)
  • K153700 — Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments (July 8, 2016)
  • K153629 — ArcadiusXP C Spinal System (May 25, 2016)
  • K153396 — Aesculap OrthoPilot Next Generation (May 16, 2016)
  • K151938 — S4 Cervical Spinal and Occiput Systems (October 21, 2015)
  • K151056 — Aesculap T-Space PEEK and XP Spinal System (August 13, 2015)
  • K150544 — Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System (May 29, 2015)

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