Ringloc HIP System
99 catalogue numbers from 106280, 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
99catalogue 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) | K050124 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 5) |
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 |
|---|---|---|
| 106280 | 80 MM 28 LINER SIZE | In distribution |
| 14-103664 | 64 MM 26 LINER SIZE | In distribution |
| 12-105951 | 28MM HEAD SIZE 21 LINER SIZE | In distribution |
| 11-103554 | 54 MM 24 LINER SIZE | In distribution |
| 105864 | 28MM HEAD SIZE 24 LINER SIZE | In distribution |
| 105422 | 22 SIZE | In distribution |
| 105426 | 26 SIZE | In distribution |
| 11-165306 | 66 SIZE 53/57MM SHELL SIZE | In distribution |
| 12-105882 | 28MM HEAD SIZE 22 LINER SIZE | In distribution |
| 106250 | 50 MM 23 LINER SIZE | In distribution |
| 11-103570 | 70 MM 26 LINER SIZE | In distribution |
| 11-165303 | 63 SIZE 46/47MM SHELL SIZE | In distribution |
| 14-104060 | 60 MM 25 LINER SIZE | In distribution |
| 11-103558 | 58 MM 23 LINER SIZE | In distribution |
| 105867 | 28MM HEAD SIZE 27 LINER SIZE | In distribution |
| 135264 | 64 MM 26 LINER SIZE | In distribution |
| 12-105904 | 28MM HEAD SIZE 24 LINER SIZE | In distribution |
| 106240 | 40 MM 20 LINER SIZE | In distribution |
| 11-103540 | 40 MM 20 LINER SIZE | In distribution |
| 106021 | 21 SIZE | In distribution |
| 106268 | 68 MM 27 LINER SIZE | In distribution |
| 14-104052 | 52 MM 23 LINER SIZE | In distribution |
| 12-105911 | 26MM HEAD SIZE 21 LINER SIZE | In distribution |
| 106252 | 52 MM 23 LINER SIZE | In distribution |
| 11-165305 | 65 SIZE 51/52MM SHELL SIZE | In distribution |
| 14-103656 | 56 MM 24 LINER SIZE | In distribution |
| 14-103654 | 54 MM 24 LINER SIZE | In distribution |
| 105421 | 21 SIZE | In distribution |
| 14-103670 | 70 MM 27 LINER SIZE | In distribution |
| 12-105905 | 28MM HEAD SIZE 25 LINER SIZE | In distribution |
| 14-103564 | 64 MM 26 LINER SIZE | In distribution |
| 106256 | 56 MM 24 LINER SIZE | In distribution |
| RD115943 | 28 MM 260 LINER SIZE | In distribution |
| RD115620 | 200 SIZE | In distribution |
| 12-105954 | 28MM HEAD SIZE 24 LINER SIZE | In distribution |
| 135244 | 44 MM 21 LINER SIZE | In distribution |
| 14-103660 | 60 MM 25 LINER SIZE | In distribution |
| 12-105898 | 32MM HEAD SIZE 28 LINER SIZE | In distribution |
| 105425 | 25 SIZE | In distribution |
| 12-105906 | 28MM HEAD SIZE 26 LINER SIZE | In distribution |
| 14-103648 | 48 MM 22 LINER SIZE | In distribution |
| 11-103566 | 66 MM 25 LINER SIZE | In distribution |
| RD115624 | 240 SIZE | In distribution |
| RD115902 | 28 MM 230 LINER SIZE | In distribution |
| 14-103668 | 68 MM 27 LINER SIZE | In distribution |
| 14-103644 | 44 MM 21 LINER SIZE | In distribution |
| 11-103564 | 64 MM 24 LINER SIZE | In distribution |
| 11-103552 | 52 MM 23 LINER SIZE | In distribution |
| 14-103580 | 80 MM 28 LINER SIZE | In distribution |
| 11-103550 | 50 MM 23 LINER SIZE | In distribution |
| RD115910 | 22MM INNER Ø 20 LINER SIZE | In distribution |
| 106246 | 46 MM 22 LINER SIZE | In distribution |
| 14-103544 | 44 MM 21 LINER SIZE | In distribution |
| 14-103646 | 46 MM 22 LINER SIZE | In distribution |
| 12-105928 | 22MM HEAD SIZE 28 LINER SIZE | In distribution |
| 12-105907 | 28MM HEAD SIZE 27 LINER SIZE | In distribution |
| 11-103568 | 68 MM 25 LINER SIZE | In distribution |
| 12-105916 | 26MM HEAD SIZE 26 LINER SIZE | In distribution |
| 11-165301 | 61 SIZE 42MM SHELL SIZE | In distribution |
| 14-104042 | 42 MM 20 LINER SIZE | In distribution |
| 14-103674 | 74 MM 28 LINER SIZE | In distribution |
| 14-103558 | 58 MM 25 LINER SIZE | In distribution |
| 12-105921 | 22MM HEAD SIZE 21 LINER SIZE | In distribution |
| RD115985 | 28 MM 230 LINER SIZE | In distribution |
| RD115984 | 28 MM 220 LINER SIZE | In distribution |
| RD115990 | 32 MM 270 LINER SIZE | In distribution |
| 11-103542 | 42 MM 20 LINER SIZE | In distribution |
| 14-103652 | 52 MM 23 LINER SIZE | In distribution |
| 11-165300 | 60 SIZE 41MM SHELL SIZE | In distribution |
| 11-103548 | 48 MM 22 LINER SIZE | In distribution |
| 14-103640 | 40 MM 20 LINER SIZE | In distribution |
| 105424 | 24 SIZE | In distribution |
| 12-105896 | 32MM HEAD SIZE 26 LINER SIZE | In distribution |
| 105423 | 23 SIZE | In distribution |
| 12-105908 | 28MM HEAD SIZE 28 LINER SIZE | In distribution |
| 135260 | 60 MM 25 LINER SIZE | In distribution |
| RD115930 | 32 MM 230 LINER SIZE | In distribution |
| RD115903 | 28 MM 240 LINER SIZE | In distribution |
| 14-104078 | 78 MM 28 LINER SIZE | In distribution |
| 14-103658 | 58 MM 25 LINER SIZE | In distribution |
| 14-103562 | 62 MM 26 LINER SIZE | In distribution |
| 14-103568 | 68 MM 27 LINER SIZE | In distribution |
| 135246 | 46 MM 22 LINER SIZE | In distribution |
| 14-103578 | 78 MM 28 LINER SIZE | In distribution |
| RD115913 | 22MM INNER Ø 22 LINER SIZE | In distribution |
| 11-103560 | 60 MM 23 LINER SIZE | In distribution |
| 135252 | 52 MM 23 LINER SIZE | In distribution |
| RD115941 | 28 MM 230 LINER SIZE | In distribution |
| 14-103666 | 66 MM 27 LINER SIZE | In distribution |
| 14-103570 | 70 MM 27 LINER SIZE | In distribution |
| 14-103542 | 42 MM 20 LINER SIZE | In distribution |
| 11-105826 | 22MM HEAD SIZE 43 LINER SIZE | In distribution |
| 14-103540 | 40 MM 20 LINER SIZE | In distribution |
| 11-103562 | 62 MM 24 LINER SIZE | In distribution |
| 11-103578 | 78 MM 28 LINER SIZE | In distribution |
| 11-103574 | 74 MM 27 LINER SIZE | In distribution |
| 12-105925 | 22MM HEAD SIZE 25 LINER SIZE | In distribution |
| 14-103546 | 46 MM 22 LINER SIZE | In distribution |
| 135266 | 66 MM 27 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
26 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 | 2024-05-17 | Class II | Labeling mix-ups | 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention | 12 units | |
| Biomet, Inc. | 510(k) number | 2020-11-25 | Class II | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. | 7428 | 2024-05-08 |
| Biomet, Inc. | 510(k) number | 2020-09-03 | Class II | Process control | Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or | 48 devices | 2022-12-20 |
| Biomet, Inc. | 510(k) number | 2019-08-21 | Class II | Environmental control | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 219988 units (total) | 2021-07-21 |
| 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 |
| Biomet, Inc. | 510(k) number | 2015-04-16 | Class III | Labeling mix-ups | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. | 1315 | 2016-05-16 |
| Biomet, Inc. | 510(k) number | 2015-01-09 | Class II | Packaging process control | Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two. | 17 | 2015-10-22 |
| 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.