Company ยท US
Implex Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2005. Name variants (Inc, Corp, punctuation) are merged.
65510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 17 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 10 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 10 |
| MQP | Spinal Vertebral Body Replacement Device | 8 |
| EZX | Mesh, Surgical, Metal | 3 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 |
| FTM | Mesh, Surgical | 1 |
| HWC | Screw, Fixation, Bone | 1 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 1 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
| LZN | Cement Obturator | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 2005 | K051978 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT Implex Corp. | MQP |
| Jun 17, 2005 | K051196 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 Implex Corp. | MQP |
| Dec 21, 2004 | K040487 | TRABECULAR METAL KNEE SYSTEM AUGMENTS Implex Corp. | MBH |
| Sep 30, 2004 | K040630 | TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ Implex Corp. | JWH |
| Jul 14, 2004 | K040756 | THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX Implex Corp. | FTM |
| Jan 8, 2004 | K031962 | NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS Implex Corp. | JWH |
| Nov 19, 2003 | K033384 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ Implex Corp. | JDK |
| Oct 31, 2003 | K032527 | HEDROCEL VERTEBRAL BODY REPLACEMENT Implex Corp. | MQP |
| Oct 2, 2003 | K032344 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 Implex Corp. | EZX |
| Sep 23, 2003 | K031449 | MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION Implex Corp. | KWS |
| Aug 21, 2003 | K032282 | MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM Implex Corp. | EZX |
| Aug 6, 2003 | K031462 | THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS Implex Corp. | MBH |
| Jul 11, 2003 | K031823 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 Implex Corp. | MQP |
| Feb 19, 2003 | K023882 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM Implex Corp. | EZX |
| Jan 15, 2003 | K024161 | NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS Implex Corp. | JWH |
| Dec 10, 2002 | K022377 | THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 Implex Corp. | KWT |
| Oct 2, 2002 | K022966 | PROXILOCK HIP PROSTHESIS; SIZE 12/36 Implex Corp. | LWJ |
| Aug 30, 2002 | K022563 | HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 Implex Corp. | MQP |
| Jul 17, 2002 | K021967 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2 Implex Corp. | MQP |
| Jul 12, 2002 | K021970 | THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #) Implex Corp. | LPH |
| May 20, 2002 | K021025 | MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ Implex Corp. | MQP |
| Feb 12, 2002 | K020295 | NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0 Implex Corp. | JWH |
| Jan 28, 2002 | K010378 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ Implex Corp. | MQP |
| Sep 26, 2001 | K012866 | THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 Implex Corp. | JWH |
| Aug 30, 2001 | K012507 | THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX) Implex Corp. | LPH |
| Jul 26, 2001 | K012095 | THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX) Implex Corp. | JWH |
| Jul 19, 2001 | K011904 | NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) Implex Corp. | JWH |
| Jan 25, 2001 | K004013 | IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY Implex Corp. | JWH |
| Nov 7, 2000 | K003181 | IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ Implex Corp. | LPH |
| Aug 24, 2000 | K001759 | HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ Implex Corp. | JDI |
| Aug 7, 2000 | K001471 | THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ Implex Corp. | LWJ |
| Jun 15, 2000 | K001039 | THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP Implex Corp. | LPH |
| May 23, 2000 | K001307 | CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ Implex Corp. | JWH |
| Mar 1, 2000 | K990330 | CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ Implex Corp. | JDI |
| Feb 18, 2000 | K994076 | IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT 05-XXX-YYYYY Implex Corp. | JWH |
| Oct 8, 1999 | K992409 | THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ Implex Corp. | JDI |
| Jul 14, 1999 | K991869 | COBREX HIP STEM, MODEL 01-128-XXXXX Implex Corp. | JDI |
| Jul 1, 1999 | K983837 | HEDROCEL ACETABULAR CAGE SYSTEM Implex Corp. | LPH |
| Jun 11, 1999 | K990183 | IMPLEX ALUMINA FEMORAL HEAD Implex Corp. | LZO |
| Jun 1, 1999 | K984290 | IMPLEX RADIAL HEAD REPLACEMENT SYSTEM Implex Corp. | KWI |
| Mar 15, 1999 | K983835 | IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA Implex Corp. | JWH |
| Feb 1, 1999 | K984291 | CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT Implex Corp. | JWH |
| Feb 1, 1999 | K982751 | IMPLEX SCREW AND WASHER SYSTEM Implex Corp. | MBI |
| Dec 16, 1998 | K980637 | IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT Implex Corp. | JWH |
| Dec 3, 1998 | K983128 | IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY Implex Corp. | JDI |
| Jul 31, 1998 | K982302 | IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS Implex Corp. | JWH |
| Jun 8, 1998 | K981560 | IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM Implex Corp. | JWH |
| May 22, 1998 | K980781 | IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS Implex Corp. | JWH |
| Apr 14, 1998 | K980486 | IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM Implex Corp. | JDI |
| Aug 6, 1997 | K971705 | IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED Implex Corp. | JDI |
Newest 50 of 65.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||