Company ยท US
Zimmer Trabecular Metal Technology, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2014. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 8 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 |
| MQP | Spinal Vertebral Body Replacement Device | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 |
| HXB | Probe | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 7, 2014 | K133784 | VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION Zimmer Trabecular Metal Technology | ODP |
| Mar 1, 2013 | K123602 | TM ARDIS INTERBODY SYSTEM INSERTER Zimmer Trabecular Metal Technology | MAX |
| Jun 29, 2012 | K120990 | NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL Zimmer Trabecular Metal Technology | MBH |
| Jun 15, 2012 | K120203 | TM-400 DEVICE Zimmer Trabecular Metal Technology, Inc. | MAX |
| May 29, 2012 | K113561 | TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION Zimmer Trabecular Metal Technology | MAX |
| Nov 18, 2011 | K111983 | VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX Zimmer Trabecular Metal Technology | ODP |
| Feb 15, 2011 | K103517 | TRABECULAR METAL FEMORAL CONE AUGMENTS Zimmer Trabecular Metal Technology, Inc. | MBH |
| Jan 10, 2011 | K103033 | TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX Zimmer Trabecular Metal Technology | ODP |
| Dec 13, 2010 | K102896 | TRABECULAR METAL TIBIAL CONE AUGMENTS Zimmer Trabecular Metal Technology | MBH |
| Mar 4, 2010 | K093127 | TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET Zimmer Trabecular Metal Technology | MQP |
| Aug 31, 2007 | K070754 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 Zimmer Trabecular Metal Technology | MQP |
| Jun 29, 2007 | K071090 | TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION Zimmer Trabecular Metal Technology | KWS |
| May 30, 2007 | K070382 | VISTA -S DEVICE Zimmer Trabecular Metal Technology | MQP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2019 | Zimmer Trabecular Metal Technology, Inc. NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws
Item Number: 00544800436
Product Usage:
The Trabecular Metal Tibial Cone Augments are inten Terminated |
JWH | K024161 |
| Feb 1, 2019 | Zimmer Trabecular Metal Technology, Inc. NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws
Item Number: 00544800426
Product Usage:
The Trabecular Metal Tibial Cone Augments are inten Terminated |
JWH | K024161 |
| Jul 7, 2016 | Zimmer Trabecular Metal Technology, Inc. The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and Terminated |
MAX | K113561 |
| Apr 15, 2016 | Zimmer Trabecular Metal Technology, Inc. 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM
00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM
00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM
00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM
00720505228 ACETAB.CUPW/SH,0 Terminated |
LPH | K964509 K980486 |
| Apr 15, 2016 | Zimmer Trabecular Metal Technology, Inc. REV. SHELL LINER 0D 28X48 00700504828
REV. SHELL LINER 10D 28X50 00701005028
REV. SHELL LINER 10D 28X52 00701005228
REV. SHELL LINER 10D 28X54 00701005428
REV. SHELL LINER 10D 28X56 00701005628 Terminated |
JDI | K980486 K983128 |
| Apr 15, 2016 | Zimmer Trabecular Metal Technology, Inc. TM MONO TIB STR GRN SZ 5 - 00588606510
TM MONO TIB STR GRN SZ 5 12MM - 00588606512
TM MONO TIB STR GRN SZ 5 14MM - 00588606514
TM MONO TIB STR GRN SZ 5 17MM - 00588606517
TM MONO TIB STR GRN SZ 6 10 Terminated |
MBH | K031462 |
| Apr 15, 2016 | Zimmer Trabecular Metal Technology, Inc. TM LPS TIB SZ 3 C/D, 10MM - 00588605310
TM LPS TIB SZ 3 C/D, 12MM - 00588605312
TM LPS TIB SZ 3 C/D, 14MM - 00588605314
TM LPS TIB SZ 3 C/D, 17MM - 00588605317
TM LPS TIB SZ 4 C/D, 10MM - 00588605 Terminated |
MBH | K031462 |
| Apr 15, 2016 | Zimmer Trabecular Metal Technology, Inc. TM CR TIB SZ 3 C-H, 10MM- 00588604310
TM CR TIB SZ 3 C-H, 12 mm - 00588604312
TM CR TIB SZ 3 C-H, 14MM - 00588604314
TM CR TIB SZ 3 C-H, 17MM - 00588604317
TM CR TIB SZ 4 C-H 10 MM - 00588604410
Terminated |
MBH | K031462 |
| Apr 15, 2016 | Zimmer Trabecular Metal Technology, Inc. POROUS PATELLA 32MM X 10MM - 00587806532
POROUS PATELLA 35MM X 10MM- 00587806535
POROUS PATELLA 38MM X 10MM - 00587806538
POROUS PATELLA 41MM X 10MM - 00587806541 Terminated |
MBH | K031462 |
| Mar 26, 2015 | Zimmer Trabecular Metal Technology, Inc. NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only.
Product Usage:
Intended for use where severe degeneration, trauma, or other pathology of the knee j Terminated |
MBH | K040487 |
| Dec 23, 2014 | Zimmer Trabecular Metal Technology, Inc. NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH
Zimmer U.K. Ltd., SN3 4FP, UK
Zimmer Trabecular Metal Technology, Inc
10 Pomeroy Road, Pa Terminated |
HXB | None listed |