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510(k) K003649

TRITON HIP SYSTEM by Hayes Medical, Inc. — Product Code LWJ

K003649 is an FDA 510(k) premarket notification submitted by Hayes Medical, Inc. for the device "TRITON HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on February 23, 2001. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Hayes Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2001
Date Received
November 27, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Hayes Medical, Inc.

  • K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT (January 31, 2007)
  • K062383 — UNISYN HA PLASMA MODULAR HIP (December 21, 2006)
  • K060635 — CONSENSUS ACETABULAR SHELL SYSTEM (April 28, 2006)
  • K030151 — CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM (April 10, 2003)
  • K030205 — CONSENSUS UNIPOLAR HEAD, COCR (April 1, 2003)
  • K021466 — CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE (July 24, 2002)
  • K020153 — CONSENSUS ACETABLAR SHELL, TI COATED (April 15, 2002)
  • K001456 — CONSENSUS KNEE SYSTEM (August 7, 2000)
  • K983004 — CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI (November 25, 1998)
  • K964395 — PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT (January 27, 1997)

Other clearances for product code LWJ

  • K120595 — UNISYN PLUS HIP STEM (October 12, 2012)
  • K103518 — TRINITY ACETABULAR SYSTEM (March 9, 2011)
  • K090764 — NOVATION CFS PRESS-FIT AND CEMENTED STEMS (April 21, 2009)
  • K082146 — METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD (September 9, 2008)
  • K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT (January 31, 2007)
  • K062978 — U2 HIP STEM, TI PLASMA SPRAY (January 16, 2007)
  • K062383 — UNISYN HA PLASMA MODULAR HIP (December 21, 2006)
  • K061699 — EXCIA (August 18, 2006)
  • K051826 — BETACONE HIP PROSTHESIS SYSTEM (November 18, 2005)
  • K050262 — U2 ACETABULAR COMPONENT (August 15, 2005)

FDA data resources