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510(k) K132312

RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM by Renovis Surgical Technologies, LLC — Product Code LPH

K132312 is an FDA 510(k) premarket notification submitted by Renovis Surgical Technologies, LLC for the device "RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM". The FDA issued a decision of Substantially Equivalent on April 11, 2014. 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. Renovis Surgical Technologies, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2014
Date Received
July 25, 2013
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 Renovis Surgical Technologies, LLC

  • K190122 — Renovis A200 PS Knee System as part of the Renovis A200 Knee System (June 20, 2019)
  • K182007 — Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System (December 7, 2018)
  • K181655 — Renovis S180 Lateral Lumbar Interbody Fusion System (September 11, 2018)
  • K180502 — S128 Anterior Lumbar Interbody Fusion (ALIF) System (June 14, 2018)
  • K171543 — Renovis Surgical Hip Replacement System (November 16, 2017)
  • K170888 — Renovis S141 Lumbar Interbody Fusion System (August 8, 2017)
  • K153250 — Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System (March 16, 2016)
  • K152193 — Renovis Anterior Cervical Plate System (September 25, 2015)
  • K143647 — Renovis Surgical Hip Replacement System (May 11, 2015)
  • K143126 — Renovis S141 Lumbar Interbody Cage System (February 6, 2015)

Other clearances for product code LPH

  • K253630 — Mpact 3D Metal Foam (August 28, 2026)
  • K254043 — TRIVANCE™ Hip Stem (August 4, 2026)
  • 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)

FDA data resources