ClearanceBrief
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)
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Top companies in KWY

DateFirm and productCodeLinked 510(k)
Nov 5, 2025Total 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
KWYK143113
Oct 14, 2025BioPro, 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
KWYK100761
Nov 7, 2024Smith & 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
KWYK023743
K211176 +1
Jun 28, 2024Exactech, 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
KWYK013211
Apr 3, 2020Biomet, Inc.
BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.
Terminated
KWYNone listed
Apr 3, 2020Biomet, Inc.
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
Terminated
KWYK052990
Apr 3, 2020Biomet, Inc.
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
Terminated
KWYK052990
Apr 3, 2020Biomet, Inc.
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
Terminated
KWYK052990
Apr 3, 2020Biomet, Inc.
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
Terminated
KWYK052990
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
Terminated
KWYK080979
K161166
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
Terminated
KWYK080979
K161166
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
Terminated
KWYK080979
K161166
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
Terminated
KWYK080979
K161166
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
Terminated
KWYK080979
K161166
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
Terminated
KWYK080979
K161166
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
Terminated
KWYK080979
K161166
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
Terminated
KWYK080979
K161166
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
Terminated
KWYK080979
K161166
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
Terminated
KWYK080979
K161166
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
Terminated
KWYK080979
K161166
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
Terminated
KWYK080979
K161166
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
Terminated
KWYK080979
K161166
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
Terminated
KWYK080979
K161166
Apr 3, 2020Biomet, Inc.
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
Terminated
KWYK080979
K161166
Aug 21, 2019Zimmer 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
KWYK062998
K112905
Sep 21, 2018Zimmer 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
KWYK052990
Nov 29, 2017Zimmer Biomet, Inc.
BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement
Terminated
KWYK833991
Aug 25, 2017Zimmer 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
KWYK150552
Aug 29, 2016Smith & 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
KWYK023743
Aug 29, 2016Smith & 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
KWYK023743
Mar 12, 2016Zimmer 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
KWYK833991
Feb 22, 2016Zimmer 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
KWYK833991
Aug 17, 2014Ortho 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
KWYK050966
Feb 20, 2014Zimmer, 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
KWYK833991
Oct 25, 2013Zimmer, Inc.
Multipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.
Terminated
KWYK833991
May 24, 2013Orthopedic 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
KWYK101670
Nov 20, 2012Zimmer, 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
KWYK833991
Nov 3, 2010Ortho Development Corporation
Distal Centralizer 10 mm
Terminated
KWYK962448
Oct 28, 2009Ortho Development Corporation
Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.
Terminated
KWYK050966
Sep 10, 2009Omni 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
KWYK082468
Sep 10, 2009Omni 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
KWYK082468
Sep 10, 2009Omni 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
KWYK082468
Sep 10, 2009Omni 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
KWYK082468
Sep 10, 2009Omni 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
KWYK082468
Sep 10, 2009Omni 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
KWYK082468
Sep 10, 2009Omni 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
KWYK082468
Sep 10, 2009Omni 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
KWYK082468
Sep 10, 2009Omni 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
KWYK082468
Sep 10, 2009Omni 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
KWYK082468
Sep 10, 2009Omni 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
KWYK082468

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