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510(k) K120038

A200 KNEE SYSTEM by Renovis Surgical Technologies, LLC — Product Code OIY

K120038 is an FDA 510(k) premarket notification submitted by Renovis Surgical Technologies, LLC for the device "A200 KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 14, 2013. The device falls under product code OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive), a Class II device regulated under 21 CFR 888.3560. Renovis Surgical Technologies, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2013
Date Received
January 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented 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 OIY

  • K252887 — DePuy ATTUNE™ Knee System (May 22, 2026)
  • K242665 — DePuy ATTUNE™ Total Knee System (November 1, 2024)
  • K201347 — DePuy ATTUNE™ Total Knee System (June 18, 2020)
  • K121727 — MOVATION KNEE SYSTEM (August 15, 2012)
  • K113756 — HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELL (March 14, 2012)
  • K111433 — DEPUY STTUNE (TM) PS KNEE SYSTEM (August 30, 2011)
  • K103756 — DEPUY ATTUNE TOTAL KNEE SYSTEM (March 15, 2011)
  • K103223 — HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS (December 21, 2010)
  • K101433 — DEPUY ATTUNE KNEE SYSTEM (December 10, 2010)
  • K091956 — HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 (September 28, 2010)

FDA data resources