Panels › Orthopedic › Product code KWY · Class 2
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Regulation 888.3390
1510(k)s in 12 months (99 all time)
1recalls in 12 months (88 all time)
86recalls that name a 510(k)
Top companies in KWY
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet, Inc. | 5 | 20 |
| Omni Life Science, Inc. | 1 | 23 |
| Encore Medical, Lp | 0 | 18 |
| Johnson & Johnson Professionals, Inc. | 9 | 0 |
| Ortho Development Corp. | 5 | 3 |
| Zimmer | 5 | 3 |
| Wright Medical Technology Inc | 0 | 7 |
| Zimmer Biomet, Inc. | 0 | 5 |
| 3M Company | 4 | 0 |
| Exactech, Inc. | 3 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2025 | Total Joint Orthopedics, Inc. Brand Name: Klassic BiPolar Head
Model/Catalog Number:
3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head;
3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head;
3205.43.022 Klassic BiPolar Hea Open, Classified |
KWY | K143113 |
| Oct 14, 2025 | BioPro, Inc. BioPro Bipolar Head
Product ID/Description
18130 BIPOLAR HEAD 38MM
18131 BIPOLAR HEAD 39MM
18132 BIPOLAR HEAD 40MM
18133 BIPOLAR HEAD 41MM
18134 BIPOLAR HEAD 42MM
18135 BIPOLAR HEAD 43MM
18136 BIPOLA Open, Classified |
KWY | K100761 |
| Nov 7, 2024 | Smith & Nephew, Inc. Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System. Open, Classified |
KWY | K023743 K211176 +1 |
| Jun 28, 2024 | Exactech, Inc. Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers:
a) 100-22-19, SZ. L;
b) 100-22-20, SZ. M;
c) 100-22-21, SZ. N;
d) 100-22-22, SZ. P;
e) 100-22-23, SZ. R;
f) 1 Open, Classified |
KWY | K013211 |
| Apr 3, 2020 | Biomet, Inc. BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972. Terminated |
KWY | None listed |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217. Terminated |
KWY | K052990 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213. Terminated |
KWY | K052990 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209. Terminated |
KWY | K052990 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207. Terminated |
KWY | K052990 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199. Terminated |
KWY | K080979 K161166 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198. Terminated |
KWY | K080979 K161166 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197. Terminated |
KWY | K080979 K161166 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196. Terminated |
KWY | K080979 K161166 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195. Terminated |
KWY | K080979 K161166 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194. Terminated |
KWY | K080979 K161166 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193. Terminated |
KWY | K080979 K161166 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192. Terminated |
KWY | K080979 K161166 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191. Terminated |
KWY | K080979 K161166 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190. Terminated |
KWY | K080979 K161166 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185. Terminated |
KWY | K080979 K161166 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184. Terminated |
KWY | K080979 K161166 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183. Terminated |
KWY | K080979 K161166 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182. Terminated |
KWY | K080979 K161166 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181. Terminated |
KWY | K080979 K161166 |
| Aug 21, 2019 | Zimmer Biomet, Inc. Compress, Mini Compress; Item Nos. 178350
178351
178352
178353
178354
178355
178356
178357
178358
178359
178360
178361
178362
178363
178364
178365
178366
178367
178368
178369
178370
178371
178372
1783 Terminated |
KWY | K062998 K112905 |
| Sep 21, 2018 | Zimmer Biomet, Inc. StageOne Hip, Models 431207 & 431209Usage:
Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. T Terminated |
KWY | K052990 |
| Nov 29, 2017 | Zimmer Biomet, Inc. BIPOLAR METAL SHELL 48 MM OD
Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement Terminated |
KWY | K833991 |
| Aug 25, 2017 | Zimmer Biomet, Inc. G7 DUAL MOBILITY LINER 44MM F
Product Usage:
Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The resu Terminated |
KWY | K150552 |
| Aug 29, 2016 | Smith & Nephew, Inc. TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR,
REF NUMBERS:
71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 7132 Terminated |
KWY | K023743 |
| Aug 29, 2016 | Smith & Nephew, Inc. TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR,
REF NUMBERS:
71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, Terminated |
KWY | K023743 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 16 consists of all product under poduct code: KWY and same usage:
Item no:
500103822 BIPOLAR LINER 38MM OD X 2
500103922 BIPOLAR LINER 39MM OD X 2
500104022 BIPOLAR LINER 40/41MM OD
50010402 Terminated |
KWY | K833991 |
| Feb 22, 2016 | Zimmer Biomet, Inc. Bipolar Shell
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
various sizes
Use of the MultiPolar Bipolar Cup is indicated in: Fracture dislocation of th Terminated |
KWY | K833991 |
| Aug 17, 2014 | Ortho Development Corporation Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY
Product Usage:
Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum Terminated |
KWY | K050966 |
| Feb 20, 2014 | Zimmer, Inc. Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several OD Terminated |
KWY | K833991 |
| Oct 25, 2013 | Zimmer, Inc. Multipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD.
Indicated in fracture dislocation of the hip. Terminated |
KWY | K833991 |
| May 24, 2013 | Orthopedic Alliance LLC Bipolar Cap, ID26mm, OD42mm
Bipolar Cap, ID28mm, OD44mm
Bipolar Cap, ID28mm, OD46mm
Bipolar Cap, ID28mm, OD48mm
Bipolar Cap, ID28mm, OD50mm
Bipolar Cap, ID28mm, OD52mm
Bipolar Cap, ID28mm, OD54mm
Bipo Terminated |
KWY | K101670 |
| Nov 20, 2012 | Zimmer, Inc. Multipolar Bipolar Cup Liner 22 mm LD.;
Item 00-5001-040-22
Product Usage:
The liner snaps into the Multipolar Bipolar Cup and serves as the articulation surface for the femoral head. The split poly Terminated |
KWY | K833991 |
| Nov 3, 2010 | Ortho Development Corporation Distal Centralizer 10 mm Terminated |
KWY | K962448 |
| Oct 28, 2009 | Ortho Development Corporation Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head. Terminated |
KWY | K050966 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 60 mm OD
Product Code: H3-82860.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 59 mm OD
Product Code: H3-82859.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 58 mm OD
Product Code: H3-82858.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 57 mm OD
Product Code: H3-82857.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 56 mm OD
Product Code: H3-82856.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 55 mm OD
Product Code: H3-82855.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 54 mm OD
Product Code: H3-82854.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 53 mm OD
Product Code: H3-82853.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 52 mm OD
Product Code: H3-82852.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 51 mm OD
Product Code: H3-82851.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 50 mm OD
Product Code: H3-82850.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
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