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510(k) K963100

TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP by Endotec, Inc. — Product Code LPH

K963100 is an FDA 510(k) premarket notification submitted by Endotec, Inc. for the device "TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP". The FDA issued a decision of Substantially Equivalent on February 12, 1997. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Endotec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1997
Date Received
August 9, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Endotec, Inc.

  • K081400 — FANNING-PAPPAS MODULAR KNEE BEARING (February 20, 2009)
  • K012702 — BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 (January 30, 2002)
  • K992394 — BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT (October 15, 1999)
  • K982418 — BUECHEL-PAPPAS MODULAR SALVAGE STEM (April 29, 1999)
  • K963101 — B-P HEMISPHERICAL ACETABULAR COMPONENT (February 12, 1997)
  • K960425 — BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX (October 3, 1996)
  • K960424 — BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD (August 26, 1996)
  • K945254 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES (June 6, 1995)
  • K944465 — CARRIER, LIGATURE (79 GEJ) (September 28, 1994)
  • K944414 — DEKALB (September 27, 1994)

Other clearances for product code LPH

  • K261624 — Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrain (July 10, 2026)
  • K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed C (June 5, 2026)
  • K251270 — Taperloc® Complete Hip Stem (May 19, 2026)
  • K252623 — G7® Revision Acetabular System (February 4, 2026)
  • K251043 — Mpact 3D Metal Implants Extension – DMLS Technology (January 28, 2026)
  • K252067 — Velora Acetabular System (December 5, 2025)
  • K252846 — TaperSet™ Hip System (November 20, 2025)
  • K251833 — EMPOWR Acetabular® Liner Extension (November 12, 2025)
  • K251718 — ArTT Augments and Buttresses and Bone Screws (August 29, 2025)
  • K250989 — Stryker and Serf hip devices (July 25, 2025)

FDA data resources