ClearanceBrief
Panels › Orthopedic › Product code LZO · Class 2

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Regulation 888.3353

9510(k)s in 12 months (535 all time)
0recalls in 12 months (177 all time)
168recalls that name a 510(k)
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Top companies in LZO

DateFirm and productCodeLinked 510(k)
Oct 14, 2025BioPro, Inc.
BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32
Open, Classified
LZOK912641
Apr 21, 2025Zimmer, Inc.
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Open, Classified
LZOK181171
Apr 21, 2025Zimmer, Inc.
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Open, Classified
LZOK181171
Apr 21, 2025Zimmer, Inc.
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Open, Classified
LZOK181171
Apr 21, 2025Zimmer, Inc.
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Open, Classified
LZOK181171
Apr 21, 2025Zimmer, Inc.
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Open, Classified
LZOK181171
Mar 24, 2025Zimmer, Inc.
Z1 Femoral Hip System, Product Number 611777612
Open, Classified
LZOK233476
Dec 26, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision
Open, Classified
LZOK142187
Sep 12, 2024Zimmer GmbH
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064
Open, Classified
LZOK082996
Sep 12, 2024Zimmer GmbH
Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066
Open, Classified
LZOK082996
May 24, 2024Smith & Nephew Inc
smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
Open, Classified
LZOK021673
K022958
Feb 29, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number:
Open, Classified
LZOK190535
Dec 18, 2023Biomet, Inc.
Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
Open, Classified
LZOK200112
Dec 18, 2023Biomet, Inc.
Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
Open, Classified
LZOK200112
Sep 19, 2023Encore Medical, LP
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
Open, Classified
LZOK082844
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-24/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-121/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-120/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-119/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-118/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-117/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-115/00
Open, Classified
LZOK183141
Aug 4, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00
Open, Classified
LZOK183141
Dec 19, 2022Corin Ltd
Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
Open, Classified
LZONone listed
Dec 19, 2022Corin Ltd
Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
Open, Classified
LZONone listed
Aug 11, 2022Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CU
Open, Classified
LZOK121392
Aug 11, 2022Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2
Open, Classified
LZOK070479
Jan 14, 2022Howmedica Osteonics Corp.
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Open, Classified
LZOK052718
Jan 14, 2022Howmedica Osteonics Corp.
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
Open, Classified
LZOK052718
Aug 12, 2021Exactech, Inc.
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Completed
LZOK060107
Aug 12, 2021Exactech, Inc.
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Completed
LZOK050398
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethyle
Open, Classified
LZOK070479
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant component.
Open, Classified
LZOK121392
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized, 36mm. Orthopedic hip implant component.
Open, Classified
LZOK070479
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant component.
Open, Classified
LZOK070479
Jul 22, 2021Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner, +5mm Lateralized, G0
Open, Classified
LZOK070479
Jul 9, 2021IMPLANTCAST GMBH
EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200
Terminated
LZOK163577
Dec 21, 2020OMNIlife science Inc.
SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
Terminated
LZOK111572
Dec 21, 2020OMNIlife science Inc.
SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728
Terminated
LZOK111572
Dec 21, 2020OMNIlife science Inc.
SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128
Terminated
LZOK111572
Jul 22, 2020Smith & Nephew Orthopaedics AG
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide
Terminated
LZOK143739
Apr 17, 2020Biomet, Inc.
Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc H
Terminated
LZOK051411
Oct 10, 2019Zimmer Biomet, Inc.
Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004
Terminated
LZOK071535
Oct 10, 2019Zimmer Biomet, Inc.
Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445
Terminated
LZONone listed
Oct 10, 2019Zimmer Biomet, Inc.
Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103 0100551104 0100551105 0100551106 0100551107 0100551108 0100551109 0100551110 0100551111 0100551112 0100551113 010055111
Terminated
LZOK071723
Oct 10, 2019Zimmer Biomet, Inc.
CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 0100296112 0100296125 0100296137 0100296150 0100296162 0100296175
Terminated
LZOK110836

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