RingLoc+ Hip System
21 catalogue numbers from 16-104162, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component). 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 | KWA |
| Device type | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) |
| Device class | Class 3 |
| Regulation | 21 CFR 888.3330 |
| 510(k) | K093235 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16-104162 | 62MM SHELL SIZE 26 LINER SIZE | In distribution |
| 16-116068 | 68MM SHELL SIZE 27 LINER SIZE | In distribution |
| 16-116078 | 78MM SHELL SIZE 28 LINER SIZE | In distribution |
| 16-104164 | 64MM SHELL SIZE 26 LINER SIZE | In distribution |
| 16-116062 | 62MM SHELL SIZE 26 LINER SIZE | In distribution |
| 16-116052 | 52MM SHELL SIZE 23 LINER SIZE | In distribution |
| 16-116044 | 44MM SHELL SIZE 21 LINER SIZE | In distribution |
| 16-104140 | 40MM SHELL SIZE 20 LINER SIZE | In distribution |
| 16-116054 | 54MM SHELL SIZE 24 LINER SIZE | In distribution |
| 16-104168 | 68MM SHELL SIZE 27 LINER SIZE | In distribution |
| 16-116066 | 66MM SHELL SIZE 27 LINER SIZE | In distribution |
| 16-116064 | 64MM SHELL SIZE 26 LINER SIZE | In distribution |
| 16-104156 | 56MM SHELL SIZE 24 LINER SIZE | In distribution |
| 16-116056 | 56MM SHELL SIZE 24 LINER SIZE | In distribution |
| 16-104158 | 58MM SHELL SIZE 25 LINER SIZE | In distribution |
| 103531 | 6.5 mm x 20 mm | In distribution |
| 16-104142 | 42MM SHELL SIZE 20 LINER SIZE | In distribution |
| 103538 | 6.5 mm x 60 mm | In distribution |
| 16-116046 | 46MM SHELL SIZE 22 LINER SIZE | In distribution |
| 16-116070 | 70MM SHELL SIZE 28 LINER SIZE | In distribution |
| 16-116080 | 80MM SHELL SIZE 28 LINER SIZE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 48 |
| Conserve® | Microport Orthopedics Inc. | 24 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | Zimmer, Inc. | 17 |
| Fitmore® Hip Stem | Zimmer, Inc. | 17 |
| Dynasty | Microport Orthopedics Inc. | 12 |
| Asphere | Depuy (Ireland) | 10 |
| Taperloc Complete Micro Primary Femoral | Biomet Orthopedics | 9 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 7 |
| Kinectiv® | Zimmer, Inc. | 7 |
| M2A – Modular Head HIP System | Biomet Orthopedics | 6 |
| Transcend® | Microport Orthopedics Inc. | 5 |
| Biolox Delta | Depuy Orthopaedics, Inc. | 4 |
Showing 12 of 20. All products under Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Recalls Naming This Product
34 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 | 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 | 2020-11-25 | 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 | 2019-03-01 | Class II | Packaging process control | Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa. | 809 total | 2020-05-27 |
| Biomet, Inc. | 510(k) number | 2019-03-01 | Class II | Packaging process control | Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa. | 809 units total | 2020-05-27 |
| Biomet, Inc. | 510(k) number | 2017-06-29 | Class II | Employee error | Device was distributed with the etching missing from the product. | 15 units | 2018-03-07 |
| Biomet, Inc. | 510(k) number | 2015-07-28 | Class II | Under Investigation by firm | The device was assembled without screw hole plugs. | 5 | 2016-05-17 |
| 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 | 10 | 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 | 49 units | 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 | 762 all products | 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 | 103 | 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 | 149 | 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 | 146 | 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 | 64 | 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 | 55 | 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 | 17 | 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 | 10 | 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 | 42 | 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 | 22 | 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 | 30 | 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 | 22 | 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 | 48 | 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 | 42 | 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 | 23 | 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 | 51 | 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 | 37 | 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 | 32 | 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 | 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 | 8 | 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.