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510(k) K940190

ULTIMA UNIPOLAR MODULAR HEAD by Johnson & Johnson Orthopaedics, Inc. — Product Code KWL

K940190 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Orthopaedics, Inc. for the device "ULTIMA UNIPOLAR MODULAR HEAD". The FDA issued a decision of Substantially Equivalent on September 29, 1994. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Johnson & Johnson Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1994
Date Received
January 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
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)
  • 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)
  • K924340 — P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT (January 25, 1994)

Other clearances for product code KWL

  • K260536 — Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement (May 15, 2026)
  • K253675 — OsteoRemedies Hip Spacer System (December 23, 2025)
  • K252326 — InterSpace GV Hip Spacer (August 6, 2025)
  • K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (June 12, 2025)
  • K234028 — COPAL® exchange G hip spacer; COPAL® G+V (February 15, 2024)
  • K222632 — UHR Bipolar Implants, Restoration GAP II Implants (October 21, 2022)
  • K192995 — OsteoRemedies Hip Spacer System (January 10, 2020)
  • K191981 — REMEDY Acetabular Cup (August 23, 2019)
  • K172906 — REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (August 29, 2018)
  • K173967 — Remedy Acetabular Cup (February 22, 2018)

FDA data resources