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510(k) K112897

RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS by Renovis Surgical Technologies, LLC — Product Code OQG

K112897 is an FDA 510(k) premarket notification submitted by Renovis Surgical Technologies, LLC for the device "RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS". The FDA issued a decision of Substantially Equivalent on June 13, 2012. The device falls under product code OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, 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
June 13, 2012
Date Received
October 3, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.

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 OQG

  • K202705 — Prime and DYNASTY® Additive Manufacturing Shells (August 20, 2021)
  • K203472 — KMTI Hip Replacement System (April 2, 2021)
  • K201660 — KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shel (July 16, 2020)
  • K200328 — Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular C (March 11, 2020)
  • K172651 — FMP Extended Liners (December 13, 2017)
  • K171543 — Renovis Surgical Hip Replacement System (November 16, 2017)
  • K173104 — Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile (October 27, 2017)
  • K143647 — Renovis Surgical Hip Replacement System (May 11, 2015)
  • K140130 — X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE H (November 6, 2014)
  • K141972 — KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY (October 9, 2014)

FDA data resources