R3 Acetabular
R3 HA Coated Acetabular Shell is a hip-replacement component placed in the pelvis to hold a compatible R3 liner. It is part of the R3 Acetabular System used with matched femoral heads and…
R3 HA Coated Acetabular Shell is a hip-replacement component placed in the pelvis to hold a compatible R3 liner. It is part of the R3 Acetabular System used with matched femoral heads and stems.
The shell combines an asymmetric StikTite porous surface with a hydroxyapatite coating. Its internal locking mechanism retains the selected acetabular insert.
Listed Item
R3 3 Hole HA Coated Acetabular Shell 48MM
Shell Options
No-hole, three-hole and multi-hole versions are available, including the listed 48 mm three-hole shell. Existing R3 liners and accessories are used with the shell. The selected hole pattern and component size form part of the surgeon’s fixation and bearing choices for primary or revision hip replacement.
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 | Smith & Nephew, Inc., 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 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K201701 |
| Record published | 2015-04-30 |
| Record revised | 2025-10-06 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71335568 | In distribution | |
| 71331868 | In distribution | |
| 71331948 | In distribution | |
| 71338742 | In distribution | |
| 71338744 | In distribution | |
| 71331968 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201701 | 2020-10-06 |
| K182535 | 2018-11-19 |
| K161233 | 2016-12-14 |
| K113848 | 2012-04-27 |
| K102370 | 2011-01-19 |
| K093363 | 2010-01-26 |
| K092386 | 2009-11-03 |
| K070756 | 2007-06-06 |
| K061253 | 2006-05-31 |
Recalls
9 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-04-22 | Class II | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells | 1766 devices | |
| 2020-04-22 | Class II | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells | 58 devices | |
| 2020-04-22 | Class II | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells | 6468 devices | |
| 2020-04-22 | Class II | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells | 4172 devices | |
| 2020-04-22 | Class II | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells | 1267 devices | |
| 2020-04-22 | Class II | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells | 1450 devices | |
| 2014-01-23 | Class II | Under Investigation by firm | Inner spherical radius of the shell is undersized. | 10 units | 2016-11-15 |
| 2013-05-29 | Class II | Packaging process control | One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner. | 53 units | 2016-03-22 |
| 2013-05-29 | Class II | Packaging process control | One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner. | 53 units | 2016-03-22 |
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.