Ringloc HIP System
139 catalogue numbers from 11-105868, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
139catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| 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 |
| 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 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| 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 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| 510(k) | K023357 |
| 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 |
|---|---|---|
| 11-105868 | 28MM HEAD SIZE 28 LINER SIZE | In distribution |
| 14-104056 | 56 MM 24 LINER SIZE | In distribution |
| XL-105934 | 32MM HEAD SIZE 24 LINER SIZE | In distribution |
| 105877 | 32MM HEAD SIZE 27 LINER SIZE | In distribution |
| RD115917 | 22MM INNER Ø 24 LINER SIZE | In distribution |
| EP-105995 | 36MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-105811 | 28MM HEAD SIZE 21 LINER SIZE | In distribution |
| XL-105926 | 32MM HEAD SIZE 26 LINER SIZE | In distribution |
| 135258 | 58 MM 25 LINER SIZE | In distribution |
| XL-155232 | 32MM HEAD SIZE 22 LINER SIZE | In distribution |
| 103537 | 6.5 mm x 50 mm | In distribution |
| 105904 | 28MM HEAD SIZE 24 LINER SIZE | In distribution |
| 105927 | 32MM HEAD SIZE 27 LINER SIZE | In distribution |
| 11-105913 | 28MM HEAD SIZE 23 LINER SIZE | In distribution |
| 105420 | 20 SIZE | In distribution |
| 12-105953 | 28MM HEAD SIZE 23 LINER SIZE | In distribution |
| 12-105918 | 26MM HEAD SIZE 28 LINER SIZE | In distribution |
| 12-105997 | 36MM HEAD SIZE 27 LINER SIZE | In distribution |
| 105993 | 26MM HEAD SIZE 23 LINER SIZE | In distribution |
| 105992 | 26MM HEAD SIZE 22 LINER SIZE | In distribution |
| EP-105780 | 32MM HEAD SIZE 22 LINER SIZE | In distribution |
| 12-105901 | 28MM HEAD SIZE 21 LINER SIZE | In distribution |
| 14-104074 | 74 MM 28 LINER SIZE | In distribution |
| 11-105906 | 28MM HEAD SIZE 26 LINER SIZE | In distribution |
| 105427 | 27 SIZE | In distribution |
| 105875 | 32MM HEAD SIZE 25 LINER SIZE | In distribution |
| 11-105840 | 22MM HEAD SIZE 20 LINER SIZE | In distribution |
| 11-105904 | 28MM HEAD SIZE 24 LINER SIZE | In distribution |
| XL-105894 | 36MM HEAD SIZE 24 LINER SIZE | In distribution |
| XL-108527 | 40MM HEAD SIZE 27 LINER SIZE | In distribution |
| 12-105996 | 36MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-155236 | 32MM HEAD SIZE 26 LINER SIZE | In distribution |
| 12-105995 | 36MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-105998 | 36MM HEAD SIZE 28 LINER SIZE | In distribution |
| EP-108526 | 40MM HEAD SIZE 26 LINER SIZE | In distribution |
| 105997 | 26MM HEAD SIZE 27 LINER SIZE | In distribution |
| 12-105917 | 26MM HEAD SIZE 27 LINER SIZE | In distribution |
| 11-105858 | 26MM HEAD SIZE 28 LINER SIZE | In distribution |
| 12-105883 | 28MM HEAD SIZE 23 LINER SIZE | In distribution |
| RD115915 | 22MM INNER Ø 23 LINER SIZE | In distribution |
| 105915 | 28MM HEAD SIZE 25 LINER SIZE | In distribution |
| EP-108527 | 40MM HEAD SIZE 27 LINER SIZE | In distribution |
| 135250 | 50 MM 23 LINER SIZE | In distribution |
| XL-105903 | 28MM HEAD SIZE 23 LINER SIZE | In distribution |
| 11-105866 | 28MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-105835 | 32MM HEAD SIZE 25 LINER SIZE | In distribution |
| 12-105922 | 22MM HEAD SIZE 22 LINER SIZE | In distribution |
| EP-195237 | 38MM HEAD SIZE 27 LINER SIZE | In distribution |
| XL-108426 | 40MM HEAD SIZE 26 LINER SIZE | In distribution |
| 11-105912 | 28MM HEAD SIZE 22 LINER SIZE | In distribution |
| EP-196235 | 40MM HEAD SIZE 25 LINER SIZE | In distribution |
| 105917 | 28MM HEAD SIZE 27 LINER SIZE | In distribution |
| XL-105994 | 36MM HEAD SIZE 24 LINER SIZE | In distribution |
| EP-105934 | 32MM HEAD SIZE 24 LINER SIZE | In distribution |
| EP-105937 | 32MM HEAD SIZE 27 LINER SIZE | In distribution |
| 12-105913 | 26MM HEAD SIZE 23 LINER SIZE | In distribution |
| EP-105916 | 36MM HEAD SIZE 26 LINER SIZE | In distribution |
| 11-105908 | 28MM HEAD SIZE 28 LINER SIZE | In distribution |
| 105905 | 28MM HEAD SIZE 25 LINER SIZE | In distribution |
| 12-105958 | 28MM HEAD SIZE 28 LINER SIZE | In distribution |
| EP-106986 | 38MM HEAD SIZE 26 LINER SIZE | In distribution |
| 11-105935 | 32MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-105817 | 28MM HEAD SIZE 27 LINER SIZE | In distribution |
| 11-105905 | 28MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-105924 | 32MM HEAD SIZE 24 LINER SIZE | In distribution |
| 105934 | 32MM HEAD SIZE 24 LINER SIZE | In distribution |
| EP-105917 | 36MM HEAD SIZE 27 LINER SIZE | In distribution |
| 12-105894 | 32MM HEAD SIZE 24 LINER SIZE | In distribution |
| 12-105926 | 22MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-105837 | 32MM HEAD SIZE 27 LINER SIZE | In distribution |
| 105911 | 28MM HEAD SIZE 21 LINER SIZE | In distribution |
| XL-108424 | 40MM HEAD SIZE 24 LINER SIZE | In distribution |
| XL-108322 | 32MM HEAD SIZE 22 LINER SIZE | In distribution |
| XL-105923 | 32MM HEAD SIZE 23 LINER SIZE | In distribution |
| 106272 | 72 MM 28 LINER SIZE | In distribution |
| 105914 | 28MM HEAD SIZE 24 LINER SIZE | In distribution |
| 11-105878 | 32MM HEAD SIZE 28 LINER SIZE | In distribution |
| 12-105888 | 28MM HEAD SIZE 28 LINER SIZE | In distribution |
| XL-156235 | 36MM HEAD SIZE 25 LINER SIZE | In distribution |
| 105861 | 28MM HEAD SIZE 21 LINER SIZE | In distribution |
| XL-105935 | 32MM HEAD SIZE 25 LINER SIZE | In distribution |
| 105916 | 28MM HEAD SIZE 26 LINER SIZE | In distribution |
| 11-105851 | 26MM HEAD SIZE 21 LINER SIZE | In distribution |
| XL-105833 | 32MM HEAD SIZE 23 LINER SIZE | In distribution |
| 11-105996 | 26MM HEAD SIZE 26 LINER SIZE | In distribution |
| 12-105914 | 26MM HEAD SIZE 24 LINER SIZE | In distribution |
| 11-105842 | 22MM HEAD SIZE 22 LINER SIZE | In distribution |
| 12-105955 | 28MM HEAD SIZE 25 LINER SIZE | In distribution |
| EP-106887 | 38MM HEAD SIZE 27 LINER SIZE | In distribution |
| 11-105936 | 32MM HEAD SIZE 26 LINER SIZE | In distribution |
| 105907 | 28MM HEAD SIZE 27 LINER SIZE | In distribution |
| 12-105895 | 32MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-105952 | 28MM HEAD SIZE 22 LINER SIZE | In distribution |
| 105874 | 32MM HEAD SIZE 24 LINER SIZE | In distribution |
| 135262 | 62 MM 26 LINER SIZE | In distribution |
| 11-105874 | 32MM HEAD SIZE 24 LINER SIZE | In distribution |
| 135256 | 56 MM 24 LINER SIZE | In distribution |
| 14-104062 | 62 MM 26 LINER SIZE | In distribution |
| 11-105985 | 22MM HEAD SIZE 25 LINER SIZE | In distribution |
| XL-105953 | 28MM HEAD SIZE 23 LINER SIZE | In distribution |
| 12-105887 | 28MM HEAD SIZE 27 LINER SIZE | In distribution |
| 11-105937 | 32MM HEAD SIZE 27 LINER SIZE | In distribution |
| 12-105885 | 28MM HEAD SIZE 25 LINER SIZE | In distribution |
| 14-104044 | 44 MM 21 LINER SIZE | In distribution |
| XL-105955 | 28MM HEAD SIZE 25 LINER SIZE | In distribution |
| 105863 | 28MM HEAD SIZE 23 LINER SIZE | In distribution |
| EP-105927 | 32MM HEAD SIZE 27 LINER SIZE | In distribution |
| XL-105816 | 28MM HEAD SIZE 26 LINER SIZE | In distribution |
| EP-105898 | 36MM HEAD SIZE 28 LINER SIZE | In distribution |
| 105902 | 28MM HEAD SIZE 22 LINER SIZE | In distribution |
| 14-104070 | 70 MM 27 LINER SIZE | In distribution |
| XL-105896 | 36MM HEAD SIZE 26 LINER SIZE | In distribution |
| 11-105926 | 32MM HEAD SIZE 26 LINER SIZE | In distribution |
| 11-105911 | 28MM HEAD SIZE 21 LINER SIZE | In distribution |
| 11-105853 | 26MM HEAD SIZE 23 LINER SIZE | In distribution |
| XL-105908 | 28MM HEAD SIZE 28 LINER SIZE | In distribution |
| EP-108222 | 32MM HEAD SIZE 22 LINER SIZE | In distribution |
| 105862 | 28MM HEAD SIZE 22 LINER SIZE | In distribution |
| 11-105900 | 22mm Head Size 20 Liner Size | In distribution |
| XL-108427 | 40MM HEAD SIZE 27 LINER SIZE | In distribution |
| 11-105982 | 22MM HEAD SIZE 22 LINER SIZE | In distribution |
| 103533 | 6.5 mm x 30 mm | In distribution |
| RD115950 | 28 MM 22 LINER SIZE | In distribution |
| XL-105898 | 36MM HEAD SIZE 28 LINER SIZE | In distribution |
| 11-105914 | 28MM HEAD SIZE 24 LINER SIZE | In distribution |
| 106248 | 48 MM 22 LINER SIZE | In distribution |
| XL-105938 | 32MM HEAD SIZE 28 LINER SIZE | In distribution |
| 11-105916 | 28MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-155237 | 32MM HEAD SIZE 27 LINER SIZE | In distribution |
| 11-105846 | 22MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-105951 | 28MM HEAD SIZE 21 LINER SIZE | In distribution |
| 105903 | 28MM HEAD SIZE 23 LINER SIZE | In distribution |
| XL-155233 | 32MM HEAD SIZE 23 LINER SIZE | In distribution |
| EP-176236 | 40MM HEAD SIZE 26 LINER SIZE | In distribution |
| XL-105881 | 28mm Head Size 21 Liner Size | In distribution |
| 12-105915 | 26MM HEAD SIZE 25 LINER SIZE | In distribution |
| 105926 | 32MM HEAD SIZE 26 LINER SIZE | In distribution |
| 106260 | 60 MM 25 LINER SIZE | In distribution |
| 12-105994 | 36MM HEAD SIZE 24 LINER SIZE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Profemur | Microport Orthopedics Inc. | 113 |
| OSS™ Orthopedic Salvage System | Biomet Orthopedics | 98 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253515 | 2026-08-24 |
| K023085 | 2002-10-17 |
| K020076 | 2002-01-30 |
Recalls Naming This Product
13 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 | 2020-04-17 | Class II | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit | 58 units | 2021-06-25 |
| 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 | 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 | 2018-04-02 | Class II | Nonconforming Material/Component | Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head. | 18 | 2020-05-12 |
| Biomet, Inc. | 510(k) number | 2017-09-15 | Class II | Error in labeling | One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being | 23 | 2018-08-20 |
| 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 | 2012-02-07 | Not classified | Employee error | Biomet initiated this action after complaints were received where OOS AVL Bushing Sets were opened during OSS knee replacement procedures, and were found to contain two tabbed bushings. | 27 units distributed US and foreign | 2013-02-06 |
| Biomet, Inc. | 510(k) number | 2011-09-13 | Not classified | Nonconforming Material/Component | Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification. | 5 devices | 2013-02-21 |
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.