Anatomic Shoulder TM Combined System
The Anatomical Shoulder Combined System brings together humeral stems, Bigliani/Flatow heads and glenoid components for conventional hemi or total shoulder arthroplasty. The range includes…
The Anatomical Shoulder Combined System brings together humeral stems, Bigliani/Flatow heads and glenoid components for conventional hemi or total shoulder arthroplasty. The range includes cemented, uncemented and fracture stems, polyethylene glenoids and Trabecular Metal glenoids.
An AS Bigliani/Flatow adaptor connects the Anatomical Shoulder stem to a Bigliani/Flatow humeral head. Its two taper interfaces match the stem and head systems, allowing those components to form the humeral assembly.
Materials and Fixation
Cemented humeral stems and heads are cobalt-chromium-molybdenum alloys. Uncemented and fracture stems and the adaptor are titanium alloy. Bigliani/Flatow glenoids are UHMWPE; Trabecular Metal glenoids combine that polymer with Trabecular Metal.
Standard cemented and revision stems use cement, standard uncemented stems use cementless fixation, and fracture stems permit either. The specified glenoid components are intended for cemented use.
6manufacturers in China registered for this device type
3catalogue numbers in this listing
8510(k) clearances naming this product code
20recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | KWT |
| Device type | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3650 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K103404 |
| Record published | 2018-03-26 |
| Record revised | 2019-04-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
| Sizes | Width 46 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SSI004358 | Sz 40 | In distribution |
| SSI004361 | Sz 52 | In distribution |
| 82-0180-119-46 | Width 46 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 336 |
| SMR Shoulder | Limacorporate | 289 |
| Tornier Perform Humeral System | Tornier Inc. | 119 |
| Bigliani/Flatow® | Zimmer, Inc. | 119 |
| Trabecular Metal® | Zimmer, Inc. | 115 |
| Jarvis Glenoid Rerverse Shoulder Prosthesis | Fournitures Hospitalieres Industrie | 103 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 86 |
| Alliance® | Zimmer, Inc. | 68 |
| Anatomical Shoulder™ | Zimmer, Inc. | 54 |
| Aetos Shoulder System | Smith & Nephew, Inc. | 53 |
| Perform™ Humeral System | Tornier Inc. | 47 |
| Bio-Modular® Shoulder System | Biomet Orthopedics | 43 |
Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150730 | 2015-06-16 |
| K121543 | 2012-10-11 |
| K110791 | 2011-09-02 |
| K103404 | 2011-03-15 |
| K050761 | 2005-04-11 |
| K041549 | 2004-09-01 |
| K982981 | 1998-12-17 |
| K790987 | 1979-06-22 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2012-05-12 | Class II | Mixed-up of materials/components | Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-00, lot 62071190. | 87 units | 2013-09-12 |
Recalls
9 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 |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 45 USA | 2014-04-16 |
| 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 | |
| 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 |
| 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 |
| 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 |
| 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 | |
| 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 |
| 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 | |
| 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 |
| 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 |
| 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.