Home / 510(k) Clearances / K922561

510(k) K922561

CONSENSUS(TM) TOTAL HIP SYSTEM by U.S. Medical Products, Inc. — Product Code JDL

K922561 is an FDA 510(k) premarket notification submitted by U.S. Medical Products, Inc. for the device "CONSENSUS(TM) TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on July 21, 1993. The device falls under product code JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3320. U.S. Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1993
Date Received
June 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3320
Review Panel
OR
Submission Type

Other clearances by U.S. Medical Products, Inc.

  • K962215 — CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER (August 15, 1996)
  • K954818 — CONSENSUS POSTERIOR STABILIZED KNEE (May 22, 1996)
  • K953443 — CONSENSUS PCL SUBSITUTING TIBIAL INSERT (April 26, 1996)
  • K960302 — CONSENSUS ACETABULAR SHELL, ALL UHMWPE (April 1, 1996)
  • K952943 — CONSENSUS ALL POLY TIBIA (April 1, 1996)
  • K960340 — CONSENSUS APEX DOME HOLE PLUG (March 15, 1996)
  • K960339 — CONSENSUS 22MM COCRMO FEMORAL HEAD (February 21, 1996)
  • K960151 — CONSENSUS 26MM COCRMO FEMORAL HEAD (February 21, 1996)
  • K960156 — CONSENSUS 32MM COCRMO FEMORAL HEAD (February 21, 1996)
  • K955386 — CONSENSUS ZIRCONIA FEMORAL HEAD (February 20, 1996)

Other clearances for product code JDL

  • K073499 — VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES (August 7, 2008)
  • K070785 — DYNASTY ACETABULAR SYSTEM (July 11, 2007)
  • K061844 — DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER (December 6, 2006)
  • K051995 — PROFEMUR RENAISSANCE HIP STEM (August 22, 2005)
  • K051348 — CONSERVE TOTAL FEMORAL HEAD (August 19, 2005)
  • K042841 — M2A/C2A ACETABULAR SYSTEM (December 21, 2004)
  • K041586 — PROFEMUR S HIP STEM (July 9, 2004)
  • K041114 — PROFEMUR TAPERED HIP STEM (May 28, 2004)
  • K004043 — METAL TRANSCEND ARTICULATION SYSTEM (July 13, 2001)
  • K950542 — METAL BACKED ACETABULAR COMPONENT (May 25, 1995)

FDA data resources