Trabecular Metal®
90 catalogue numbers from 00-4349-012-13, listed by Zimmer, Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
90catalogue numbers in this listing
1510(k) clearance
3recalls on this code
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K052906 |
| Record published | 2015-09-17 |
| Record revised | 2023-05-03 (version 6) |
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 | Length 15 to 200 mm; height 15 to 21 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-4349-012-13 | 12 mm Stem Diameter, 130 mm Stem Length | In distribution |
| 4342-106-13 | 6 mm Stem Diameter, 130 mm Stem Length, 42, Degrees | In distribution |
| 00-4309-036-00 | Plus 0 mm Offset, 36 mm Diameter | In distribution |
| 4342-112-17 | 12 mm Stem Diameter, 170 mm Stem Length, 42, Degrees | In distribution |
| 00-4312-014-17 | 14 mm Diameter | In distribution |
| 4309-51-18 | Height 18 mm | In distribution |
| 4342-111-13 | 11 mm Stem Diameter, 130 mm Stem Length, 42, Degrees | In distribution |
| 00-4309-045-20 | 7.5 mm Diameter | In distribution |
| 00-4309-065-03 | Plus (+) 3 mm Offset, 36 mm Diameter, 65 Degree Neck Angle | In distribution |
| 00-4309-047-15 | Length 15 mm | In distribution |
| 00-4350-017-13 | 17 mm, Stem, Diameter | In distribution |
| 00-4350-014-20 | 14 mm Stem Diameter, 200 mm Stem Length | In distribution |
| 00-4309-028-00 | 40 mm | In distribution |
| 00-4309-021-14 | 14 mm | In distribution |
| 4309-52-18 | Height 18 mm | In distribution |
| 4309-18-10 | 48 Degrees, 9/10 mm Diameter | In distribution |
| 4309-17 | In distribution | |
| 00-4312-008-02 | Length 200 mm | In distribution |
| 00-4349-020-00 | 20 mm Post Length | In distribution |
| 4348-114-13 | 14 mm Stem Diameter, 130 mm Stem Length, 48, Degrees | In distribution |
| 00-4349-040-03 | Plus 3 mm Offset, 40 mm, Diameter | In distribution |
| 00-4349-040-06 | Plus 6 mm Offset, 40 mm, Diameter | In distribution |
| 4309-01-16 | 16 mm Diameter | In distribution |
| 4342-115-13 | 15 mm Stem Diameter, 130 mm Stem Length, 42, Degrees | In distribution |
| 00-4312-007-00 | 7 mm Diameter | In distribution |
| 00-4349-010-13 | 10 mm Stem Diameter, 130 mm Stem Length | In distribution |
| 4342-110-13 | 10 mm Stem Diameter, 130 mm Stem Length, 42, Degrees | In distribution |
| 00-4309-040-03 | Plus 3 mm Offset, 40 mm Diameter | In distribution |
| 00-4312-008-17 | Length 170 mm | In distribution |
| 00-4349-066-03 | Plus 3 mm Offset, 65 Degree Neck Angle, 40 mm, Diameter | In distribution |
| 4309-52-15 | Height 15 mm | In distribution |
| 4309-06 | 48 Degrees | In distribution |
| 00-4309-040-01 | 40 mm Diameter | In distribution |
| 4348-111-13 | 11 mm Stem Diameter, 130 mm Stem Length, 48, Degrees | In distribution |
| 00-4309-066-00 | Plus (+) 0 mm Offset, 40 mm Diameter, 65 Degree Neck Angle | In distribution |
| 00-4312-018-02 | 18 mm Diameter | In distribution |
| 00-4312-018-00 | 18 mm Diameter | In distribution |
| 00-4312-009-02 | 9 mm Diameter | In distribution |
| 00-4309-045-02 | 7.5 mm Diameter | In distribution |
| 4348-110-13 | 10 mm Stem Diameter, 130 mm Stem Length, 48, Degrees | In distribution |
| 00-4309-021-18 | 18 mm Diameter | In distribution |
| 00-4350-015-13 | 15 mm Stem Diameter, 130 mm Stem Length | In distribution |
| 4342-110-17 | 10 mm Stem Diameter, 170 mm Stem Length, 42, Degrees | In distribution |
| 00-4312-013-13 | Length 130 mm | In distribution |
| 00-4309-045-30 | Length 30 mm | In distribution |
| 4309-01 | 42 Degrees | In distribution |
| 00-4309-026-00 | In distribution | |
| 4348-113-13 | 13 mm Stem Diameter, 130 mm Stem Length, 48, Degrees | In distribution |
| 4342-116-13 | 16 mm Stem Diameter, 130 mm Stem Length, 42, Degrees | In distribution |
| 4309-12-06 | Length 130 mm | In distribution |
| 00-4349-020-02 | 20 mm Post Length, +2 mm Lateral Offset | In distribution |
| 47-4309-046-01 | 2.5 mm Diameter | In distribution |
| 00-4309-023-10 | 10 mm | In distribution |
| 00-4312-006-00 | 6 mm Diameter | In distribution |
| 00-4349-066-00 | Plus 0 mm Offset, 65 Degree Neck Angle, 40 mm, Diameter | In distribution |
| 00-4309-047-00 | In distribution | |
| 00-4312-008-20 | 8 mm Diameter | In distribution |
| 47-4309-061-30 | Length 30 mm | In distribution |
| 00-4349-039-12 | Size 12 mm | In distribution |
| 00-4312-015-02 | Length 200 mm | In distribution |
| 4348-115-13 | 15 mm Stem Diameter, 130 mm Stem Length, 48, Degrees | In distribution |
| 00-4312-019-02 | Length 200 mm | In distribution |
| 00-4349-065-06 | Plus 6 mm Offset, 65 Degree Neck Angle, 36 mm, Diameter | In distribution |
| 00-4349-012-17 | 12 mm Stem Diameter, 170 mm Stem Length | In distribution |
| 00-4350-012-13 | 12 mm Stem Diameter, 130 mm Stem Length | In distribution |
| 4348-109-13 | 9 mm Stem Diameter, 130 mm Stem Length, 48, Degrees | In distribution |
| 00-4312-014-20 | Length 200 mm | In distribution |
| 00-4312-009-13 | Length 130 mm | In distribution |
| 00-4309-029-02 | In distribution | |
| 4309-51-15 | Height 15 mm | In distribution |
| 4309-18-06 | Length 130 mm | In distribution |
| 00-4312-010-20 | 10 mm Diameter | In distribution |
| 00-4309-042-01 | 40 mm | In distribution |
| 00-4350-018-20 | 18 mm, Stem, Diameter | In distribution |
| 4309-18-16 | 48 Degrees, 15/16 mm Diameter | In distribution |
| 00-4312-010-13 | 10 mm Diameter | In distribution |
| 00-4349-040-03 | Plus 3 mm Offset, 40 mm, Diameter | In distribution |
| 00-4312-016-20 | Length 200 mm | In distribution |
| 00-4309-023-14 | 14 mm | In distribution |
| 4309-51-21 | Height 21 mm | In distribution |
| 00-4349-016-13 | 16 mm Stem Diameter, 130 mm Stem Length | In distribution |
| 00-4349-040-00 | Plus 0 mm Offset, 40 mm, Diameter | In distribution |
| 4342-108-13 | 8 mm Stem Diameter, 130 mm Stem Length, 42, Degrees | In distribution |
| 00-4349-037-00 | In distribution | |
| 00-4350-006-13 | 6 mm Stem Diameter, 130 mm Stem Length | In distribution |
| 00-4309-036-03 | Plus 3 mm Offset, 36 mm Diameter | In distribution |
| 00-4349-015-00 | 15 mm Post Length | In distribution |
| 00-4349-025-02 | 25 mm Post Length, +2 mm Lateral Offset | In distribution |
| 4309-02 | 48 Degrees | In distribution |
| 00-4349-036-00 | Plus 0 mm Offset, 36 mm, Diameter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| FX V135 | Fx Shoulder Solutions SAS | 127 |
| Acumed | Acumed LLC | 112 |
| Promos | Smith & Nephew, Inc. | 104 |
| Bigliani/Flatow® | Zimmer, Inc. | 86 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 85 |
| Arthrex® | Arthrex, Inc. | 75 |
| SMR System | Limacorporate | 72 |
| DJO Surgical | Encore Medical, L.P. | 70 |
| Humeris Shoulder | Fx Solutions | 69 |
| Prima | Limacorporate | 67 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161620 | 2016-11-01 |
Recalls Naming This Product
18 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| Zimmer, Inc. | 510(k) number | 2017-05-22 | Class II | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | 2825 units | 2019-03-29 |
| Zimmer, Inc. | 510(k) number | 2014-01-10 | Class II | Nonconforming Material/Component | This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of the minimum required | 10 units | 2014-09-11 |
| Zimmer, Inc. | 510(k) number | 2013-12-10 | Class II | Labeling mix-ups | Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and | 25 | 2014-09-11 |
| Zimmer, Inc. | 510(k) number | 2013-10-17 | Class II | Device Design | As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Gl | 73,002 units | 2014-09-12 |
| Zimmer, Inc. | 510(k) number | 2013-08-01 | Class II | Device Design | Zimmer is initiating a lot specific recall of the Trabecular Metal” Reverse Glenosphere Distractor due to the potential of the device not functioning properly should it be utilized without proper lubrication. As a result, there is a potenti | 771 | 2015-03-02 |
| Zimmer, Inc. | 510(k) number | 2013-06-11 | Class II | Packaging process control | The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devi | 1 | 2014-01-30 |
| Zimmer, Inc. | 510(k) number | 2010-09-10 | Not classified | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, dela | 9,790 total distal pilots in distribution. | 2012-09-14 |
| Zimmer, Inc. | 510(k) number | 2010-09-10 | Not classified | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, dela | 9,790 total distal pilots in distribution. | 2012-09-14 |
| Zimmer, Inc. | 510(k) number | 2010-09-10 | Not classified | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, dela | 13,093 total reamers in distribution. | 2012-09-14 |
| Zimmer, Inc. | 510(k) number | 2010-09-10 | Not classified | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, dela | 2012-09-14 | |
| Zimmer, Inc. | 510(k) number | 2010-09-10 | Not classified | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, dela | 2012-09-14 | |
| Zimmer, Inc. | 510(k) number | 2010-09-10 | Not classified | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, dela | 2012-09-14 | |
| Zimmer, Inc. | 510(k) number | 2009-09-17 | Not classified | Other | Some of the devices may possess a taper which will not mate with the humeral head, as intended. | 12 | 2009-12-22 |
| Zimmer, Inc. | 510(k) number | 2009-09-17 | Not classified | Other | Some of the devices may possess a taper which will not mate with the humeral head, as intended. | 12 | 2009-12-22 |
| Zimmer, Inc. | 510(k) number | 2006-07-20 | Not classified | Other | Components may not lock together as intended. | 197 for all three recalls Z-1416-1418-06 | 2007-12-19 |
| Zimmer, Inc. | 510(k) number | 2006-07-20 | Not classified | Other | Components may not lock together as intended. | 197 for all three recalls Z-1416-1418-06 | 2007-12-19 |
| Zimmer, Inc. | 510(k) number | 2006-07-20 | Not classified | Other | Components may not lock together as intended. | 197 for all three recalls Z-1416-1418-06 | 2007-12-19 |
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.