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510(k) K932210

ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT by Dow Corning Wright — Product Code JWH

K932210 is an FDA 510(k) premarket notification submitted by Dow Corning Wright for the device "ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT". The FDA issued a decision of SN on September 7, 1994. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Dow Corning Wright has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
September 7, 1994
Date Received
May 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Dow Corning Wright

  • K932911 — ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT (June 30, 1994)
  • K934354 — LACEY ALL POLYETHYLENE TIBIAL COMPONENT (June 3, 1994)
  • K932222 — SLT FEMORAL HEAD (May 27, 1994)
  • K932858 — ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT (February 16, 1994)
  • K930228 — ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE (November 30, 1993)
  • K925900 — LACEY REVISION FEMORAL COMPONENT (August 24, 1993)
  • K930189 — ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP (August 6, 1993)
  • K930188 — ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT (August 3, 1993)
  • K930190 — ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP (August 2, 1993)
  • K926257 — ORTHOLOC ADVANTIM THICK TIBIAL BASE COMPONENT (May 18, 1993)

Other clearances for product code JWH

  • K262057 — GMK Extension (September 15, 2026)
  • K260063 — GSPE Spacer (September 11, 2026)
  • K262293 — EVOLUTION MPX™ Total Knee System (September 10, 2026)
  • K262341 — b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensio (September 8, 2026)
  • K262130 — ATTUNE Revision Knee System (September 4, 2026)
  • K253961 — SK Knee System (September 1, 2026)
  • K261563 — Freedom Total Knee System (E-Poly Tibial Liners) (August 7, 2026)
  • K262251 — ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert (July 31, 2026)
  • K261734 — Klassic Infection Spacer System (July 23, 2026)
  • K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System (June 25, 2026)

FDA data resources