510(k) Report

FDA applicant

Endotec, Inc.

South Orange, NJ15 decisions1991–20096 recalls

FDA records 15 decisions for Endotec, Inc. (South Orange, NJ) from 1991 to 2009: 15 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and JDI (Prosthesis, Hip, Semi-Constrained…). 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Endotec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

6in 2009

2009: 6
2007high 6 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Endotec, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2decisions
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2decisions
  • KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2decisions
  • GCJLaparoscope, General & Plastic Surgery2decisions
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Also: MJT (1), HSD (1), KWT (1), KXA (1).

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K992394Buechel-Pappas Humeral Head Resurfacing ComponentEndotec, Inc. · 19992cite it
  • K012702Buechel-Pappas (B-P) Fixed Bearing New Jersey (NJ) Total Knee, Model 1Endotec, Inc. · 20021cites it
  • K904870Modified New Jersey Femoral Hip Resurfacing ComponEndotec, Inc. · 19911cites it

What has FDA decided for it lately?

  • K081400Fanning-Pappas Modular Knee BearingEndotec, Inc. · 2009
  • K012702Buechel-Pappas (B-P) Fixed Bearing New Jersey (NJ) Total Knee, Model 1Endotec, Inc. · 20021 recall
  • K992394Buechel-Pappas Humeral Head Resurfacing ComponentEndotec, Inc. · 1999
  • K982418Buechel-Pappas Modular Salvage StemEndotec, Inc. · 1999
  • K963100Tronzo Acetabular Fixation Component (1 99-02-00XX (Ace. Fixation Cup) XX=OD of Ace. CupEndotec, Inc. · 1997
  • K963101B-P Hemispherical Acetabular ComponentEndotec, Inc. · 19971 recall
  • K960425Buechel-Pappas Polyethlene Acetabular Component (01-42-Yyxx & 01-43-YyxxEndotec, Inc. · 19963 recalls
  • K960424Buechel-Pappas Polyethylene Glenoid Component (02-11-Yyxx) Note:YY=ID & XX=ODEndotec, Inc. · 1996

All 15 as Endotec, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K963101Endotec Prothesis Hip, Titanium Alloy, Sterilized. Acetabular Bearing, BP Hip System…Jun 5, 2009
  • K012702Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained, Cemented…Jun 5, 2009
  • K904880Endotec Prosthesis Shoulder, Titanium Alloy, Sterilized Modular Femoral Stem BP Shoulder…Jun 5, 2009
  • K842234Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System…Jun 5, 2009
  • K842234Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System…Jun 5, 2009
  • K842234Endotec Prothesis Ankle, Titanium Alloy, Sterilized. BP Ankle System, Talar Ankle…Jun 5, 2009