Echo® Bi-Metric® Hip System
18 catalogue numbers from 192521, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
18catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| 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 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MAY |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| 510(k) | K070274 |
| Record published | 2018-11-13 |
| Record revised | 2025-05-30 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 192521 | 21 Size 185 mm Type I Taper | In distribution |
| 192012 | 12 SIZE 140 MM TYPE I TAPER | In distribution |
| 192407 | 7 Size 115 mm Type I Taper | In distribution |
| 192117 | 17 Size 165 mm Type I Taper | In distribution |
| 192113 | 13 Size 145 mm Type I Taper | In distribution |
| 192518 | 18 SIZE 170 MM TYPE I TAPER | In distribution |
| 192108 | 8 SIZE 120 MM TYPE I TAPER | In distribution |
| 192009 | 9 Size 125 mm Type I Taper | In distribution |
| 192510 | 10 Size 130 mm Type I Taper | In distribution |
| 192515 | 15 SIZE 155 MM TYPE I TAPER | In distribution |
| 192116 | 16 Size 160 mm Type I Taper | In distribution |
| 192413 | 13 SIZE 145 MM TYPE I TAPER | In distribution |
| 192415 | 15 SIZE 155 MM TYPE I TAPER | In distribution |
| 192411 | 11 SIZE 135 MM TYPE I TAPER | In distribution |
| 192409 | 9 Size 125 mm Type I Taper | In distribution |
| 192516 | 16 SIZE 160 MM TYPE I TAPER | In distribution |
| 192021 | 21 Size 185 mm Type I Taper | In distribution |
| 192517 | 17 Size 165 mm Type I Taper | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument | Howmedica Osteonics Corp | 136 |
| Arcos Modular Revision System | Biomet Orthopedics | 48 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 40 |
| Ringloc HIP System | Biomet Orthopedics | 36 |
| Restoration | Howmedica Osteonics Corp | 29 |
| Arcos | Biomet Orthopedics | 19 |
| Trident | Howmedica Osteonics Corp | 12 |
| Arcos® STS™ Modular Revision System | Biomet Orthopedics | 10 |
| Ringloc Ranawat / Burstein HIP System | Biomet Orthopedics | 10 |
| OrthoMedFlex | Orthomedflex LLC | 10 |
| Taperloc Complete Rasp/Provisional | Biomet Orthopedics | 9 |
| Regenerex® Ringloc®+ Hip System | Biomet Orthopedics | 9 |
Showing 12 of 40. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2018-06-08 | Class II | Process control | Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component. | 12 | 2020-04-14 |
| Biomet, Inc. | 510(k) number | 2017-06-05 | Class II | Labeling False and Misleading | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. | 2018-03-06 | |
| Biomet, Inc. | 510(k) number | 2012-11-06 | Class II | Labeling Change Control | It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem. | 4 | 2013-08-28 |
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.