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510(k) K060635

CONSENSUS ACETABULAR SHELL SYSTEM by Hayes Medical, Inc. — Product Code LPH

K060635 is an FDA 510(k) premarket notification submitted by Hayes Medical, Inc. for the device "CONSENSUS ACETABULAR SHELL SYSTEM". The FDA issued a decision of Substantially Equivalent on April 28, 2006. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Hayes Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2006
Date Received
March 10, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
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)
  • 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)
  • K003649 — TRITON HIP SYSTEM (February 23, 2001)
  • 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 LPH

  • K261624 — Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrain (July 10, 2026)
  • K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed C (June 5, 2026)
  • K251270 — Taperloc® Complete Hip Stem (May 19, 2026)
  • K252623 — G7® Revision Acetabular System (February 4, 2026)
  • K251043 — Mpact 3D Metal Implants Extension – DMLS Technology (January 28, 2026)
  • K252067 — Velora Acetabular System (December 5, 2025)
  • K252846 — TaperSet™ Hip System (November 20, 2025)
  • K251833 — EMPOWR Acetabular® Liner Extension (November 12, 2025)
  • K251718 — ArTT Augments and Buttresses and Bone Screws (August 29, 2025)
  • K250989 — Stryker and Serf hip devices (July 25, 2025)

FDA data resources