Biocore9 Acetabular Bearing System
Biocore9 acetabular bearing component is a liner used within the matching acetabular shell during total hip replacement. The system is intended for primary or revision surgery in skeletally…
Biocore9 acetabular bearing component is a liner used within the matching acetabular shell during total hip replacement. The system is intended for primary or revision surgery in skeletally mature patients and includes compatible components for cemented or cementless arthroplasty.
The liner forms the socket-side bearing surface that articulates with an appropriately sized femoral head. Ten flexible lip tabs lock it into the acetabular shell, and three tabs resist rotation. It is used with compatible BioPro PSL hip components.
Listed Item
Acetabular Bearing Component – 49 mm I.D. x 62 mm O.D.
Bearing Material
The liner is made from highly crosslinked ultra-high-molecular-weight polyethylene. Bearing sizes range from 39 to 52 millimetres in internal diameter. It is a single-use implant.
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 10 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Record
| Listed by | BIOCORE9 LLC, United States |
|---|---|
| FDA product code | LPH |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Manufacturer |
| 510(k) | K212761 |
| Record published | 2026-06-26 |
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, manufacturing date |
| Storage | Handling environment temperature 5 to 40 °C; Storage environment temperature 5 to 40 °C |
| Sizes | Lumen/inner diameter 39 to 52.5 mm; outer diameter 50 to 66 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Acetabular Bearing Component – 49 mm I.D. x 62 mm O.D. | Lumen/Inner Diameter 49 mm | In distribution |
| Acetabular Bearing Component – 50 mm I.D. x 64 mm O.D. | Lumen/Inner Diameter 50 mm | In distribution |
| Acetabular Bearing Component – 43 mm I.D. x 56 mm O.D. | Lumen/Inner Diameter 43 mm | In distribution |
| Acetabular Bearing Component – 48 mm I.D. x 62 mm O.D. | Lumen/Inner Diameter 48 mm | In distribution |
| Acetabular Bearing Component – 51 mm I.D. x 64 mm O.D. | Lumen/Inner Diameter 51 mm | In distribution |
| Acetabular Bearing Component – 47 mm I.D. x 60 mm O.D. | Lumen/Inner Diameter 47 mm | In distribution |
| Acetabular Bearing Component – 45 mm I.D. x 58 mm O.D. | Lumen/Inner Diameter 45 mm | In distribution |
| Acetabular Bearing Component – 39 mm I.D. x 50 mm O.D. | Lumen/Inner Diameter 39 mm | In distribution |
| Acetabular Bearing Component – 44 mm I.D. x 56 mm O.D. | Lumen/Inner Diameter 44 mm | In distribution |
| Acetabular Bearing Component – 46 mm I.D. x 60 mm O.D. | Lumen/Inner Diameter 46 mm | In distribution |
| Acetabular Bearing Component – 42 mm I.D. x 54 mm O.D. | Lumen/Inner Diameter 42 mm | In distribution |
| Acetabular Bearing Component – 52 mm I.D. x 66 mm O.D. | Lumen/Inner Diameter 52.5 mm | In distribution |
| Acetabular Bearing Component – 40 mm I.D. x 52 mm O.D. | Lumen/Inner Diameter 40 mm | In distribution |
| Acetabular Bearing Component – 41 mm I.D. x 52 mm O.D. | Lumen/Inner Diameter 41 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Initia Total Hip System | Kyocera Medical Technologies, Inc. | 1,000 |
| DJO Surgical | Encore Medical, L.P. | 624 |
| Pinnacle | Depuy Orthopaedics, Inc. | 613 |
| Trilogy® Longevity® | Zimmer, Inc. | 564 |
| Instrument | Howmedica Osteonics Corp | 369 |
| InSitu Hip System | Nextstep Arthropedix | 368 |
| Trilogy® | Zimmer, Inc. | 359 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 298 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Zimmer, Inc. | 286 |
| Bencox Hip System | Corentec Co., Ltd. | 286 |
| OrthoMedFlex | Orthomedflex LLC | 257 |
| Sterizo Total Hip System | CPM Medical Consultants, LLC. | 240 |
Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212761 | 2022-05-17 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P880025 | 1991-12-04 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy Intl., Ltd. |
| P880076 | 1991-06-17 | WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS | Dow Corning Wright |
| P850061 | 1991-03-08 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. |
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.