Ringloc RX90-2 HIP System
38 catalogue numbers from 11-105978, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
38catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | 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 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MEH |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| 510(k) | K042989 |
| Record published | 2015-10-24 |
| 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 |
|---|---|---|
| 11-105978 | 32MM HEAD SIZE 48 LINER SIZE | In distribution |
| XL-129053 | 28mm Head Size 43 Liner Size | In distribution |
| 12-105962 | 22mm Head Size 42 Liner Size | In distribution |
| 11-105947 | 28mm Head Size 47 Liner Size | In distribution |
| 11-105952 | 28mm Head Size 42 Liner Size | In distribution |
| 12-105937 | 28MM HEAD SIZE 47 LINER SIZE | In distribution |
| XL-104944 | 28mm Head Size 44 Liner Size | In distribution |
| XL-129056 | 28MM HEAD SIZE 46 LINER SIZE | In distribution |
| 12-105948 | 32MM HEAD SIZE 48 LINER SIZE | In distribution |
| XL-129058 | 28mm Head Size 48 Liner Size | In distribution |
| 11-105823 | 22MM HEAD SIZE 43 LINER SIZE | In distribution |
| 12-105947 | 32MM HEAD SIZE 47 LINER SIZE | In distribution |
| 12-105963 | 22mm Head Size 43 Liner Size | In distribution |
| 11-105951 | 28mm Head Size 41 Liner Size | In distribution |
| 11-105956 | 28MM HEAD SIZE 46 LINER SIZE | In distribution |
| 11-105954 | 28mm Head Size 44 Liner Size | In distribution |
| XL-104948 | 28MM HEAD SIZE 48 LINER SIZE | In distribution |
| 11-105952 | 28MM HEAD SIZE 42 LINER SIZE | In distribution |
| XL-129053 | 28MM HEAD SIZE 43 LINER SIZE | In distribution |
| XL-129057 | 28mm Head Size 47 Liner Size | In distribution |
| 11-105965 | 32MM HEAD SIZE 45 LINER SIZE | In distribution |
| 10-129058 | 28MM HEAD SIZE 48 LINER SIZE | In distribution |
| 11-105943 | 28mm Head Size 43 Liner Size | In distribution |
| 11-105975 | 32MM HEAD SIZE 45 LINER SIZE | In distribution |
| 12-105937 | 28mm Head Size 47 Liner Size | In distribution |
| XL-104942 | 28mm Head Size 42 Liner Size | In distribution |
| 12-105963 | 22MM HEAD SIZE 43 LINER SIZE | In distribution |
| 11-105973 | 32mm Head Size 43 Liner Size | In distribution |
| XL-104946 | 28mm Head Size 46 Liner Size | In distribution |
| 10-129055 | 28MM HEAD SIZE 45 LINER SIZE | In distribution |
| 12-105938 | 28mm Head Size 48 Liner Size | In distribution |
| 10-129054 | 28MM HEAD SIZE 44 LINER SIZE | In distribution |
| XL-106952 | 28MM HEAD SIZE 42 LINER SIZE | In distribution |
| 11-105955 | 28mm Head Size 45 Liner Size | In distribution |
| XL-106953 | 28mm Head Size 43 Liner Size | In distribution |
| 11-105968 | 32mm Head Size 48 Liner Size | In distribution |
| XL-129052 | 28mm Head Size 42 Liner Size | In distribution |
| 11-105953 | 28MM HEAD SIZE 43 LINER SIZE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alteon | Exactech, Inc. | 326 |
| Novation | Exactech, Inc. | 317 |
| Pinnacle | Depuy Orthopaedics, Inc. | 305 |
| SP-CL Hip Stem | Waldemar Link GmbH & Co. KG | 219 |
| Emperion | Smith & Nephew, Inc. | 201 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 154 |
| Instrument | Howmedica Osteonics Corp | 145 |
| Restoration | Howmedica Osteonics Corp | 144 |
| Mfinity Femoral System | Medacta International SA | 138 |
| Echelon | Smith & Nephew, Inc. | 134 |
| Trinity Acetabular Hip System | Corin Limited | 128 |
| Redapt | Smith & Nephew, Inc. | 127 |
Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K021403 | 2002-05-31 |
| K020963 | 2002-04-16 |
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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2017-02-17 | Class II | Process design | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. | 28,253 in total | 2018-01-29 |
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.