Trabecular Metal®
48 catalogue numbers from 00-5450-017-31, listed by Zimmer Trabecular Metal Technology, Inc., United States, under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
48catalogue numbers in this listing
3510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Zimmer Trabecular Metal Technology, Inc., United States |
|---|---|
| FDA product code | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K103517 |
| Record published | 2015-09-24 |
| Record revised | 2023-02-03 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Height 15 to 35 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-5450-017-31 | Height 30 mm | In distribution |
| 00-5450-018-31 | Height 30 mm | In distribution |
| 00-5450-020-35 | Height 35 mm | In distribution |
| 00-5450-067-21 | SIZE: 67 mm LARGE | In distribution |
| 00-5452-013-40 | 67 MM | In distribution |
| 00-5450-017-30 | Height 30 mm | In distribution |
| 00-5452-013-34 | In distribution | |
| 00-5450-021-36 | Height 35 mm | In distribution |
| 00-5451-013-56 | 55 MM x 36 MM | In distribution |
| 00-5450-022-36 | SIZE LARGE – RIGHT | In distribution |
| 00-5451-021-36 | In distribution | |
| 00-5451-013-51 | 51 MM x 34 MM | In distribution |
| 00-5452-013-22 | In distribution | |
| 00-5451-013-60 | 60 MM x 36 MM | In distribution |
| 00-5450-013-31 | SIZE MEDIUM, 31 mm x 31 mm | In distribution |
| 00-5452-013-60 | 60 MM x 36 MM | In distribution |
| 00-5451-013-31 | 31 MM x 31 MM | In distribution |
| 00-5452-013-07 | SIZE 7 | In distribution |
| 00-5452-017-61 | In distribution | |
| 00-5450-022-35 | SIZE LARGE – LEFT | In distribution |
| 00-5452-013-56 | 55 MM x 36 MM | In distribution |
| 00-5451-013-61 | 60 MM x 36 MM | In distribution |
| 00-5452-013-67 | 67 MM x 38 MM | In distribution |
| 00-5451-018-30 | In distribution | |
| 00-5452-013-25 | In distribution | |
| 00-5452-013-75 | In distribution | |
| 00-5450-067-20 | Height 30 mm | In distribution |
| 00-5450-013-60 | Height 25 mm | In distribution |
| 00-5450-019-31 | Height 30 mm | In distribution |
| 00-5450-018-30 | SIZE MEDIUM – LEFT | In distribution |
| 00-5450-013-41 | SIZE MEDIUM, 41 mm x 34 mm | In distribution |
| 00-5451-013-46 | 46 MM x 34 MM | In distribution |
| 00-5452-013-02 | SIZE 2 | In distribution |
| 00-5451-013-67 | 67 MM x 38 MM | In distribution |
| 00-5451-020-36 | In distribution | |
| 00-5450-052-01 | SIZE: 52 mm SMALL | In distribution |
| 00-5451-018-31 | In distribution | |
| 00-5452-013-37 | 55 MM | In distribution |
| 00-5452-013-31 | 31 MM x 31 MM | In distribution |
| 00-5450-013-36 | SIZE MEDIUM, 36 mm x 31 mm | In distribution |
| 00-5452-013-68 | 67 MM x 38 MM | In distribution |
| 00-5451-013-41 | 41 MM x 34 MM | In distribution |
| 00-5450-013-52 | Height 25 mm | In distribution |
| 00-5451-019-30 | In distribution | |
| 00-5452-013-72 | In distribution | |
| 00-5451-002-00 | In distribution | |
| 00-5452-013-33 | In distribution | |
| 00-5452-013-51 | 51 MM x 34 MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| Attune | Depuy (Ireland) | 234 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120990 | 2012-06-29 |
| K103517 | 2011-02-15 |
| K102896 | 2010-12-13 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-04-15 | Class II | Unknown/Undetermined by firm | Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integ | 19,884 total | 2017-11-29 |
| 2016-04-15 | Class II | Unknown/Undetermined by firm | Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integ | 19,884 total | 2017-11-29 |
| 2016-04-15 | Class II | Unknown/Undetermined by firm | Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integ | 19,884 total | 2017-11-29 |
| 2016-04-15 | Class II | Unknown/Undetermined by firm | Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integ | 19,884 total | 2017-11-29 |
| 2015-02-04 | Class II | Error in labeling | One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed. | 1 unit | 2015-07-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.