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510(k) K120595

UNISYN PLUS HIP STEM by Consensus Orthopedics, Inc. — Product Code LWJ

K120595 is an FDA 510(k) premarket notification submitted by Consensus Orthopedics, Inc. for the device "UNISYN PLUS HIP STEM". The FDA issued a decision of Substantially Equivalent on October 12, 2012. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Consensus Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2012
Date Received
February 28, 2012
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 Consensus Orthopedics, Inc.

  • K170344 — Tahoe Uni Knee System (October 5, 2017)
  • K163167 — CKS Plus Knee System (August 9, 2017)
  • K160515 — PS2 Knee System (December 19, 2016)
  • K143725 — Consensus Knee System Modular Tibial Baseplate (March 4, 2015)
  • K133919 — CONSENSUS VITALITE TIBIAL INSERT (July 14, 2014)
  • K141043 — CS2 MULTI-HOLE ACETABULAR SHELL (May 19, 2014)
  • K130652 — VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT (December 17, 2013)
  • K122512 — CS2 HIP SYSTEM (November 5, 2012)
  • K121935 — TAPERSET HIP SMALL STEMS (September 10, 2012)
  • K121263 — TAPER SET HIP SYSTEM RDP STEM (May 22, 2012)

Other clearances for product code LWJ

  • 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)
  • K042344 — EXCIA TOTAL HIP SYSTEM (March 16, 2005)

FDA data resources