510(k) K171543

Renovis Surgical Hip Replacement System by Renovis Surgical Technologies — Product Code OQG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 16, 2017
Date Received: May 26, 2017
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

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)
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)
K141676 — RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM (November 4, 2014)

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)
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)
K140701 — NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG (June 27, 2014)