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510(k) K925900

LACEY REVISION FEMORAL COMPONENT by Dow Corning Wright — Product Code JWH

K925900 is an FDA 510(k) premarket notification submitted by Dow Corning Wright for the device "LACEY REVISION FEMORAL COMPONENT". The FDA issued a decision of Substantially Equivalent on August 24, 1993. 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
SESE (Substantially Equivalent)
Decision Date
August 24, 1993
Date Received
November 20, 1992
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

  • K932210 — ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT (September 7, 1994)
  • 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)
  • 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