Home / 510(k) Clearances / K122512

510(k) K122512

CS2 HIP SYSTEM by Consensus Orthopedics, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2012
Date Received
August 17, 2012
Clearance Type
Traditional
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 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)
  • K120595 — UNISYN PLUS HIP STEM (October 12, 2012)
  • K121935 — TAPERSET HIP SMALL STEMS (September 10, 2012)
  • K121263 — TAPER SET HIP SYSTEM RDP STEM (May 22, 2012)

Other clearances for product code LPH

  • 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)
  • K243456 — ONVOY™ Acetabular System (June 6, 2025)
  • K242744 — Trinity EVO Acetabular Shell (June 5, 2025)
  • K242232 — Mpact 3D Metal Augments II (April 23, 2025)