RingLoc Hip System
15 catalogue numbers from EP-108223, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | LWJ |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| 510(k) | K090103 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EP-108223 | 36MM HEAD SIZE 23 LINER SIZE | In distribution |
| EP-106988 | 38MM HEAD SIZE 28 LINER SIZE | In distribution |
| EP-105882 | 28MM HEAD SIZE 22 LINER SIZE | In distribution |
| EP-106996 | 38MM HEAD SIZE 26 LINER SIZE | In distribution |
| EP-109826 | 44MM HEAD SIZE 26 LINER SIZE | In distribution |
| 123741 | 3/8 – 24 THREAD | In distribution |
| EP-108322 | 32MM HEAD SIZE 22 LINER SIZE | In distribution |
| EP-107928 | 40MM HEAD SIZE 28 LINER SIZE | In distribution |
| EP-105817 | 28MM HEAD SIZE 27 LINER SIZE | In distribution |
| EP-105933 | 32MM HEAD SIZE 23 LINER SIZE | In distribution |
| EP-108321 | 28MM HEAD SIZE 21 LINER SIZE | In distribution |
| EP-195236 | 38MM HEAD SIZE 26 LINER SIZE | In distribution |
| 106022 | 22 SIZE | In distribution |
| EP-105790 | 36MM HEAD SIZE 23 LINER SIZE | In distribution |
| EP-105996 | 36MM HEAD SIZE 26 LINER SIZE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Iconacy i-Hip | Iconacy Orthopedic Implants, LLC | 154 |
| ZMR® | Zimmer, Inc. | 129 |
| Instrument | Howmedica Osteonics Corp | 120 |
| Restoration | Howmedica Osteonics Corp | 66 |
| U2 Hip Stem | United Orthopedic Corp. | 60 |
| Trinity Acetabular Hip System | Corin Limited | 58 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Exactech, Inc. | 51 |
| Omnifit | Howmedica Osteonics Corp | 48 |
| Novation | Exactech, Inc. | 48 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 46 |
| Trident | Howmedica Osteonics Corp | 43 |
| Kinectiv® | Zimmer, Inc. | 41 |
Showing 12 of 131. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Recalls Naming This Product
19 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 | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 15 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 7 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 16 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 16 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 8 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 15 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 16 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 1 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 14 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 7 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 8 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 8 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 8 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 16 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 31 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 8 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 7 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 28 | 2011-09-16 |
| Biomet, Inc. | 510(k) number | 2011-04-14 | Not classified | Employee error | The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot b | 16 | 2011-09-16 |
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.