R3 HA Coated Acetabular Shells
FDA 510(k) K201701 · Smith & Nephew, Inc.
510(k) numberK201701
Submission
- Device name
- R3 HA Coated Acetabular Shells
- Applicant
- Smith & Nephew, Inc.
Cordova, TN, US - Received
- June 22, 2020
- Decision date
- October 6, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBL – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201157 | Prime BIOFOAM® Multi-Hole ShellsMBL · Traditional | Microport Orthopedics, Inc. | 08/24/2021SE |
| K182535 | R3 Anteverted LinersMBL · Special | Smith & Nephew, Inc. | 11/19/2018SE |
| K161233 | OXINIUM DH Fermoral HeadsMBL · Traditional | Smith & Nephew, Inc. | 12/14/2016SE |
| K122382 | Dynasty Biofoam ShellMBL · Special | Wrightmedicaltechnologyinc | 10/22/2012SE |
| K113848 | R3 Xlpe LinersMBL · Traditional | Smith & Nephew, Inc. | 04/27/2012SE |
| K102370 | R3 Xlpe Anteverted LinersMBL · Abbreviated | Smith & Nephew, Inc. | 01/19/2011SE |
| K093363 | Cocr and Oxinium Femoral Heads and R3 Xlpe LinersMBL · Traditional | Smith & Nephew, Inc. | 01/26/2010SE |
| K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersMBL · Abbreviated | Smith & Nephew, Inc. | 11/03/2009SE |
| K070756 | Smith and Nephew Reflection 3 Acetabular SystemMBL · Special | Smith & Nephew, Inc. | 06/06/2007SE |
| K061253 | Reflection 3 Acetabular SystemMBL · Special | Smith & Nephew, Inc. | 05/31/2006SE |
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| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
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| K241666 | EVOS Pelvic and Acetabular SystemHRS · Traditional | 02/19/2025SE |
Questions and answers
When was R3 HA Coated Acetabular Shells cleared by the FDA?
R3 HA Coated Acetabular Shells (K201701) received a 510(k) decision of Substantially Equivalent on October 6, 2020, 106 days after the submission was received.
What is the product code of K201701?
The FDA product code is MBL – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous, a Class II (moderate risk) device regulated under 21 CFR 888.3358.