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510(k) K042896

SMITH & NEPHEW HYBRID KNEE FEMORAL by Smith & Nephew, Inc. — Product Code NPJ

K042896 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "SMITH & NEPHEW HYBRID KNEE FEMORAL". The FDA issued a decision of Substantially Equivalent on January 12, 2005. The device falls under product code NPJ (Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2005
Date Received
October 20, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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

The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.

Other clearances by Smith & Nephew, Inc.

  • K261462 — LANDMARK Total Knee System (September 8, 2026)
  • K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MI (July 9, 2026)
  • DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455) (July 6, 2026)
  • K254084 — AETOS Shoulder System - CONCELOC Glenoids (April 6, 2026)
  • K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0 (October 29, 2025)
  • K252129 — AETOS Shoulder System Stemless Humeral Prosthesis (October 3, 2025)
  • K251627 — BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPT (June 25, 2025)
  • K243608 — TRIGEN Stable Lock Nut & Washer (June 12, 2025)
  • K250677 — LEGION Total Knee System (April 2, 2025)
  • K250571 — CATALYSTEM Femoral Stems (March 28, 2025)

Other clearances for product code NPJ

  • K150307 — RESTORIS Multicompartmental Knee System (March 10, 2015)
  • K133039 — RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (December 10, 2013)
  • K093513 — IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM (December 16, 2009)
  • K093056 — SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM (December 15, 2009)
  • K090763 — RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM (June 17, 2009)
  • K070849 — DEPUY GCK FEMORAL AND TIBIAL COMPONENTS (June 26, 2007)
  • K061648 — DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) (September 11, 2006)
  • K061569 — SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS (July 6, 2006)
  • K053488 — CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM (March 9, 2006)
  • K052265 — SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL (December 27, 2005)

FDA data resources