Company ยท US
Endotec, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2009. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
20recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NRA | Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing | 13 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 9 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 1 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 1 |
| MJT | Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 20, 2009 | K081400 | FANNING-PAPPAS MODULAR KNEE BEARING Endotec, Inc. | JWH |
| Jan 30, 2002 | K012702 | BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 Endotec, Inc. | JWH |
| Oct 15, 1999 | K992394 | BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT Endotec, Inc. | HSD |
| Apr 29, 1999 | K982418 | BUECHEL-PAPPAS MODULAR SALVAGE STEM Endotec, Inc. | MJT |
| Feb 12, 1997 | K963101 | B-P HEMISPHERICAL ACETABULAR COMPONENT Endotec, Inc. | LPH |
| Feb 12, 1997 | K963100 | TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP Endotec, Inc. | LPH |
| Oct 3, 1996 | K960425 | BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX Endotec, Inc. | JDI |
| Aug 26, 1996 | K960424 | BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD Endotec, Inc. | KWT |
| Jun 6, 1995 | K945254 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES Endotec, Inc. | GEI |
| Sep 28, 1994 | K944465 | CARRIER, LIGATURE (79 GEJ) Endotec, Inc. | GCJ |
| Sep 27, 1994 | K944414 | DEKALB Endotec, Inc. | GCJ |
| May 19, 1993 | K905262 | BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH Endotec, Inc. | JDI |
| May 23, 1991 | K904870 | MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON Endotec, Inc. | KXA |
| Jan 28, 1991 | K904880 | BUECHEL-PAPPAS HUMERAL STEM COMPONENT Endotec, Inc. | KWS |
| Jan 28, 1991 | K904879 | BEUCHEL-PAPPAS GLENOID COMPONENT Endotec, Inc. | KWS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Endotec, Inc. "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Terminated |
NRA | None listed |
| Jan 11, 2012 | Endotec, Inc. "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Terminated |
NRA | None listed |
| Jan 11, 2012 | Endotec, Inc. "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Terminated |
NRA | None listed |
| Jan 11, 2012 | Endotec, Inc. "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Terminated |
NRA | None listed |
| Jan 11, 2012 | Endotec, Inc. "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***"
SIZE 3-3X7.5 CAT 04-63 Terminated |
NRA | None listed |
| Jan 11, 2012 | Endotec, Inc. "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***"
SIZE 3-3X5 CAT 04-63-2 Terminated |
NRA | None listed |
| Jan 11, 2012 | Endotec, Inc. "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***"
SIZE 3-3X2.5 CAT 04-63 Terminated |
NRA | None listed |
| Jan 11, 2012 | Endotec, Inc. "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***"
SIZE 3-3X0 CAT 04-63-2 Terminated |
NRA | None listed |
| Jan 11, 2012 | Endotec, Inc. "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***"
SIZE 1 x 10mm CAT 04-33-0041;
SIZE 2 x 10mm C Terminated |
NRA | None listed |
| Jan 11, 2012 | Endotec, Inc. "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***"
SIZE 1 x 7.5mm CAT 04-33-0031;
SIZE 2 x 7.5mm Terminated |
NRA | None listed |
| Jan 11, 2012 | Endotec, Inc. "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***"
SIZE 1 x 5mm CAT 04-33-0021;
SIZE 2 x 5mm CAT Terminated |
NRA | None listed |
| Jan 11, 2012 | Endotec, Inc. "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***"
SIZE 1 x 2.5mm CAT 04-33-0011;
SIZE 2 x 2.5mm Terminated |
NRA | None listed |
| Jan 11, 2012 | Endotec, Inc. "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***"
SIZE 1 x 0mm CAT 04-33-0001;
SIZE 2 x 0mm CAT Terminated |
NRA | None listed |
| May 20, 2010 | Endotec, Inc. Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System.
BP Ankle System, B-P Type II Talar Ankle Component:
Size 1 B-P Type II Talar Ankle Component Catalog: 05-01-0101,
Size 2 B-P Ty Terminated |
JWH | K842234 K904870 +1 |
| May 20, 2010 | Endotec, Inc. TMJ Components:
Right Ramus Component - DelCristo Catalog: 09-11-0215,
TMJ - Shah Catalog: 09-42-0217, 09-11-0217.
Left Fossa Component - DelCristo Catalog 09-42-0216,
Left Ramus Component - DelCrist Terminated |
JWH | None listed |
| May 20, 2010 | Endotec, Inc. Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System.
BP Ankle System, F-P Type III Ankle Bearing Component:
2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532,
2x7mm F-P Type III Terminated |
JWH | K842234 K904870 +1 |
| May 20, 2010 | Endotec, Inc. Endotec Prothesis Ankle, Titanium Alloy, Sterilized.
BP Ankle System, Talar Ankle Component:
Size 2 Talar Component Catalog: 05-01-0002,
Size 3 Talar Component Catalog: 05-01-0003,
Size 4 Talar Com Terminated |
JWH | K842234 K904870 +1 |
| May 20, 2010 | Endotec, Inc. Endotec Prothesis Hip, Titanium Alloy, Sterilized.
Acetabular Bearing, BP Hip System Component:
32x54 Acetabular Bearing, Catalog: 01-02-3254,
32x56 Acetabular Bearing, Catalog: 01-02-3256,
Femora Terminated |
JWH | K963101 |
| May 20, 2010 | Endotec, Inc. Endotec Prosthesis Shoulder, Titanium Alloy, Sterilized
Modular Femoral Stem BP Shoulder Component:
12mm Modular Femoral Stem, Catalog: 02-21-0103, Lot 02-21-0103ANN374. Terminated |
JWH | K904880 |
| May 20, 2010 | Endotec, Inc. Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, Titanium Alloy, Sterilized, (Beuchel-Pappas (BP))
The B-P Knee Replacement System is composed of sev Terminated |
JWH | K012702 |