Regenerex Ringloc + HIP System
12 catalogue numbers from PT-104066, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). 4 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 |
| 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MBL |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| 510(k) | K070369 |
| 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 |
|---|---|---|
| PT-104066 | 66 MM 26 LINER SIZE | In distribution |
| PT-106052 | 52 MM 23 LINER SIZE | In distribution |
| PT-116056 | 56 MM 24 LINER SIZE | In distribution |
| PT-106052 | 52 mm 23 Liner Size | In distribution |
| PT-104062 | 62 MM 25 LINER SIZE | In distribution |
| PT-104048 | 48 mm 22 Liner Size | In distribution |
| PT-106060 | 60 mm 25 Liner Size | In distribution |
| PT-106070 | 70 mm 27 Liner Size | In distribution |
| PT-106056 | 56 MM 24 LINER SIZE | In distribution |
| PT-116046 | 46 mm 21 Liner Size | In distribution |
| PT-116066 | 66 MM 26 LINER SIZE | In distribution |
| PT-104052 | 52 mm 23 Liner Size | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R3 | Smith & Nephew, Inc. | 177 |
| Instrument | Howmedica Osteonics Corp | 100 |
| Reflection | Smith & Nephew, Inc. | 89 |
| Profemur® | Microport Orthopedics Inc. | 53 |
| Delta | Limacorporate | 44 |
| Onvoy | Globus Medical, Inc. | 40 |
| Restoration | Howmedica Osteonics Corp | 39 |
| Dynasty | Microport Orthopedics Inc. | 28 |
| Delta Liners & Accessories | Limacorporate | 27 |
| R3, Stiktite | Smith & Nephew, Inc. | 26 |
| Biolox Delta | Limacorporate | 19 |
| Tri-plus | Ortho Development Corp. | 16 |
Showing 12 of 96. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
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.