Anatomical Shoulder™
A.S. Humeral stem Rev. 12 cemented
8manufacturers in China registered for this device type
52catalogue 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) | K062029 |
| Record published | 2017-11-30 |
| Record revised | 2023-06-28 (version 9) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 6 to 52 mm; length 70 to 200 mm; height 15 to 19 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01.04223.024 | 4.5-24 | In distribution |
| 01.04227.488 | Ø48 r=26.7mm | In distribution |
| 01.04201.183 | Ø18-120 | In distribution |
| 01.04235.186 | In distribution | |
| 01.04201.073 | Ø7-90 | In distribution |
| 01.04227.440 | Left | In distribution |
| 01.04215.073 | Outer Diameter 7 mm | In distribution |
| 01.04227.485 | Right | In distribution |
| 01.04215.122 | 12 | In distribution |
| 01.04211.143 | Outer Diameter 14 mm | In distribution |
| 01.04201.142 | 14 | In distribution |
| 01.04235.185 | In distribution | |
| 72.11.20-06 | In distribution | |
| 01.04227.408 | Ø40 r=22.8mm | In distribution |
| 01.04217.132 | Length 200 mm | In distribution |
| 01.04201.103 | Ø10.5-100 | In distribution |
| 01.04211.072 | 7 | In distribution |
| 01.04211.092 | 9 | In distribution |
| 01.04211.093 | Ø9-100 | In distribution |
| 01.04207.073 | Ø7-110 | In distribution |
| 01.04207.123 | Ø12-110 | In distribution |
| 01.04211.142 | 14 | In distribution |
| 01.04558.013 | In distribution | |
| 01.04212.420 | Height 15 mm | In distribution |
| 01.04201.143 | Length 100 mm | In distribution |
| 01.04201.063 | Length 70 mm | In distribution |
| 01.04212.520 | Outer Diameter 52 mm | In distribution |
| 01.04227.445 | Right | In distribution |
| 01.04237.190 | In distribution | |
| 01.04215.093 | Outer Diameter 9 mm | In distribution |
| 01.04207.142 | Length 130 mm | In distribution |
| 01.04227.369 | Ø36 r=19.8mm | In distribution |
| 01.04217.153 | Ø15-200 | In distribution |
| 01.04227.405 | Outer Diameter 40 mm | In distribution |
| 01.04237.180 | In distribution | |
| 01.04215.123 | Ø12-200 | In distribution |
| 01.04212.440 | Height 16 mm | In distribution |
| 01.04558.022 | In distribution | |
| 01.04217.072 | Length 140 mm | In distribution |
| 01.04237.200 | In distribution | |
| 01.04215.093 | Ø9-200 | In distribution |
| 01.04237.610 | In distribution | |
| 01.04207.163 | Ø16-130 | In distribution |
| 01.04215.163 | Ø16-200 | In distribution |
| 01.04207.092 | Outer Diameter 9 mm | In distribution |
| 01.04227.102 | In distribution | |
| 01.04236.115 | In distribution | |
| 01.04215.093 | Outer Diameter 9 mm | In distribution |
| 01.04215.103 | Ø10.5-200 | In distribution |
| 01.04207.072 | Outer Diameter 7 mm | In distribution |
| 01.04207.093 | Ø9-110 | In distribution |
| 01.04211.122 | 12 | 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 |
| Trabecular Metal® | Zimmer, Inc. | 90 |
| 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 |
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
8 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 | 2016-05-17 | Class II | Device Design | In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the | 177 | 2016-10-31 |
| Zimmer, Inc. | 510(k) number | 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 | 260 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 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 Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 139 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 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 | 224 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 | 54 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 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 Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 26 | 2014-04-16 |
| 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
1 of these is 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 |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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.