Home / 510(k) Clearances / K914439

510(k) K914439

P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL by Johnson & Johnson Orthopaedics, Inc. — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1991
Date Received
October 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3520
Review Panel
OR
Submission Type

Other clearances by Johnson & Johnson Orthopaedics, Inc.

  • K931466 — PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI (December 6, 1994)
  • K935452 — P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT (October 6, 1994)
  • K940190 — ULTIMA UNIPOLAR MODULAR HEAD (September 29, 1994)
  • K933275 — P.F.C. CERAMIC HIP HEAD (September 28, 1994)
  • K932595 — ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR (September 20, 1994)
  • K931655 — P.F.C. BIPOLAR HIP SYSTEM (June 9, 1994)
  • K933867 — UNIVERSAL INSET PATELLA (June 6, 1994)
  • K935262 — P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA (June 3, 1994)
  • K931189 — P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET (February 9, 1994)
  • K931054 — TRICK MODULAR KNEE TIBIAL TRAY-POROUS (January 25, 1994)

Other clearances for product code HSX

  • K251771 — Cambridge Partial Knee (December 16, 2025)
  • K251834 — Persona Partial Knee (August 15, 2025)
  • K251618 — MOTO Partial Knee System Extension (July 24, 2025)
  • K251453 — Arthrex iBalance Partial Knee System (July 1, 2025)
  • K241260 — ACTIFY™ Unicondylar Knee System (December 6, 2024)
  • K242711 — JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (October 30, 2024)
  • K242746 — OvertureTi Knee Resurfacing SystemTM (October 7, 2024)
  • K232114 — TRIBRID® Unicompartmental Knee System (April 4, 2024)
  • K221292 — Uni Knee Resurfacing System (March 10, 2023)
  • K212870 — TLC Unicompartmental Knee System (June 16, 2022)