Home / 510(k) Clearances / K930712

510(k) K930712

P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR by Johnson & Johnson Orthopaedics, Inc. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1993
Date Received
February 11, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
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 LZO

  • K252401 — implaFit® short stems (March 12, 2026)
  • K253171 — Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (January 15, 2026)
  • K250450 — Coated hip implants (September 19, 2025)
  • K243021 — Longboard Revision Hip Stem (August 7, 2025)
  • K251906 — Z1 Hip System (July 18, 2025)
  • K251292 — RECLAIM Monobloc Revision Femoral Stem (May 23, 2025)
  • K243927 — MobileLink Acetabular Cup System - inhouse coatings (May 16, 2025)
  • K250444 — NEXUS® Hip Stem (May 15, 2025)
  • K243043 — Origin™ Cemented Hip Stem (May 2, 2025)
  • K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter) (April 18, 2025)