Panels › Orthopedic › Product code MBL · Class 2
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Regulation 888.3358
0510(k)s in 12 months (13 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in MBL
| Company | 510(k)s | Recalls |
|---|---|---|
| Smith & Nephew, Inc. | 9 | 9 |
| Microport Orthopedics, Inc. | 1 | 1 |
| Ortho Development Corporation | 0 | 2 |
| Arthronics, Inc. | 1 | 0 |
| Smith & Nephew Richards, Inc. | 1 | 0 |
| Wrightmedicaltechnologyinc | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2020 | Smith & Nephew, Inc. smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Size REF/product number
48MM 71338733
50MM 71338734
52MM 71338735
54MM 71338736
56MM 7133 Open, Classified |
MBL | K070756 |
| Apr 22, 2020 | Smith & Nephew, Inc. smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Sizes REF/product number
48MM 71338663
50MM 71338664
52MM 71338665
54MM 71338666
56MM 71338667
58MM Open, Classified |
MBL | K070756 |
| Apr 22, 2020 | Smith & Nephew, Inc. smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Size REF/product number
42MM 71331942
46MM 71331946
48MM 71331948
50MM 71331950
52MM 7133 Open, Classified |
MBL | K070756 |
| Apr 22, 2020 | Smith & Nephew, Inc. smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Size REF/product number
40MM 71335540
42MM 71335542
44MM 71335544
46MM 71335546
48MM 71335548
50MM Open, Classified |
MBL | K070756 |
| Apr 22, 2020 | Smith & Nephew, Inc. smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Size REF/product number
42MM 71332242
46MM 71332246
48MM 71332248
50MM 71332250
52MM 71332 Open, Classified |
MBL | K070756 |
| Apr 22, 2020 | Smith & Nephew, Inc. smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Size REF/product number
42MM 71331842
48MM 71331848
50MM 71331850
52MM 71331852
54MM 71331854
56MM 71 Open, Classified |
MBL | K070756 |
| Sep 28, 2015 | MicroPort Orthopedics, Inc. PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper.
Orthopedic hip prosthesis component. Terminated |
MBL | K091423 K100866 |
| Feb 21, 2014 | Smith & Nephew Inc Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc.
Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; Terminated |
MBL | K960094 |
| Aug 8, 2013 | Smith & Nephew Inc R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760.
Orthopaedic. Terminated |
MBL | K113848 |
| Aug 8, 2013 | Smith & Nephew Inc R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762.
Orthopaedic. Terminated |
MBL | K113848 |
| Jun 20, 2011 | Ortho Development Corporation Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho Development, Draper, Utah 84020.
Intended for use in total hip arthroscopy. Device fixation is achieved by an o Terminated |
MBL | K053293 |
| Jun 20, 2011 | Ortho Development Corporation Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R, Ortho Development, Draper, Utah 84020.
Intended for use in total hip arthroscopy. Device fixation is achieved by an o Terminated |
MBL | K053293 |
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