Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
The semi-constrained uncemented porous metal/polymer hip prosthesis is an orthopedic implant used to replace the hip joint in patients with hip disease, utilizing a porous surface coating to allow bone ingrowth for cementless fixation. It is classified as FDA Class II under 21 CFR 888.3358 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MBL and it carries an implant flag. Full GMP compliance is required and the device does not sustain life.
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Basic Information
- Product Code
- MBL
- Device Class
- FDA class 2
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K201157 | Prime BIOFOAM® Multi-Hole Shells | Aug 24, 2021 | Substantially Equivalent | Microport Orthopedics, Inc. |
| K201701 | R3 HA Coated Acetabular Shells | Oct 06, 2020 | Substantially Equivalent | Smith & Nephew, Inc. |
| K182535 | R3 Anteverted Liners | Nov 19, 2018 | Substantially Equivalent | Smith & Nephew, Inc. |
| K161233 | OXINIUM DH Fermoral Heads | Dec 14, 2016 | Substantially Equivalent | Smith & Nephew, Inc. |
| K122382 | DYNASTY BIOFOAM SHELL | Oct 22, 2012 | Substantially Equivalent | Wrightmedicaltechnologyinc |
| K113848 | R3 XLPE LINERS | Apr 27, 2012 | Substantially Equivalent | Smith & Nephew, Inc. |
| K102370 | R3 XLPE ANTEVERTED LINERS | Jan 19, 2011 | Substantially Equivalent | Smith & Nephew, Inc. |
| K093363 | COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS | Jan 26, 2010 | Substantially Equivalent | Smith & Nephew, Inc. |
| K092386 | R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS | Nov 03, 2009 | Substantially Equivalent | Smith & Nephew, Inc. |
| K070756 | SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM | Jun 06, 2007 | Substantially Equivalent | Smith & Nephew, Inc. |
| K061253 | REFLECTION 3 ACETABULAR SYSTEM | May 31, 2006 | Substantially Equivalent | Smith & Nephew, Inc. |
| K960094 | REFLECTION DUAL DIMENSION SHELL | Mar 27, 1996 | Substantially Equivalent | Smith & Nephew Richards, Inc. |
| K931107 | LOGYK ACETABULAR COMPONENT SYSTEM | Mar 28, 1994 | Substantially Equivalent | Arthronics, Inc. |
FEI Numbers
This FDA classification entry is associated with 116 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 116 registration numbers. Click on an entry to view related FDA registrations.