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510(k) K810230

CONDYLAR KNEE W/METAL ENCAPSULATED TIB by Hexcel Medical — Product Code HRY

K810230 is an FDA 510(k) premarket notification submitted by Hexcel Medical for the device "CONDYLAR KNEE W/METAL ENCAPSULATED TIB". The FDA issued a decision of Substantially Equivalent on March 6, 1981. 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. Hexcel Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1981
Date Received
January 27, 1981
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 Hexcel Medical

  • K840416 — HEXCELITE (March 23, 1984)
  • K820890 — URETHANE ORTHOPAEDIC CASTING TAPE (June 23, 1982)
  • K812669 — SEATTLE II TOTAL HIP SYSTEM (October 2, 1981)
  • K812687 — BRIGHAM II TOTAL HIP SYSTEM (October 2, 1981)
  • K812068 — PROPOSED CONTROLS FOR DOSIMETRIC RELEASE (September 8, 1981)
  • K811164 — URETHANE ORTHOPAEDIC CASTING TAPE (May 27, 1981)
  • K810956 — MARCOVE HUMERAL ROD (April 17, 1981)
  • K810957 — MARCOVE INTRAMEDULLARY ROD (April 17, 1981)
  • K800051 — HEXCEL FEMORAL COMPONENT HIP PROSTHESIS (January 28, 1980)
  • K800050 — ANITOMIC TOTAL HIP SYSTEM (January 24, 1980)

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