AML
AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 13.5mm LARGE STATURE HIGH OFFSET 160mm LENGTH 52mm OFFSET
13manufacturers in China registered for this device type
12catalogue numbers in this listing
12510(k) clearances naming this product code
20recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| 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 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Depuy Orthopaedics, Inc., United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K012364 |
| Record published | 2015-09-24 |
| Record revised | 2024-11-25 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2020-12-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1554-03-135 | In distribution | |
| 1554-01-210 | In distribution | |
| 1554-02-195 | In distribution | |
| 1554-02-225 | In distribution | |
| 1554-03-165 | In distribution | |
| 1554-03-180 | In distribution | |
| 1554-01-150 | In distribution | |
| 1554-01-195 | In distribution | |
| 1554-02-135 | In distribution | |
| 1554-01-180 | In distribution | |
| 1554-02-105 | Withdrawn | |
| 1554-01-120 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093646 | 2009-12-17 |
| K090998 | 2009-06-12 |
| K082239 | 2008-08-29 |
| K042959 | 2004-12-22 |
| K023453 | 2002-11-13 |
| K013352 | 2001-12-17 |
| K013350 | 2001-11-07 |
| K011367 | 2001-06-15 |
| K003421 | 2000-12-01 |
| K983136 | 1998-11-25 |
| K982918 | 1998-10-05 |
| K980513 | 1998-04-14 |
Recalls
20 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 |
|---|---|---|---|---|---|
| 2021-05-07 | Class II | Employee error | Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product. | 50 units | 2023-03-09 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | 85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | Eighty-five (85) LUSTER Cemented Polished Femoral Hip Stems | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots | 2013-03-05 |
| 2012-05-16 | Class II | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a h | (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots | 2013-03-05 |
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.