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)
Top companies in LZO
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer GmbH | 34 | 35 |
| Stryker Howmedica Osteonics | 0 | 51 |
| Medacta International | 38 | 0 |
| Exactech, Inc. | 21 | 15 |
| Corin U.S.A. Limited | 27 | 5 |
| Biomet, Inc. | 21 | 8 |
| Howmedica Osteonics | 24 | 2 |
| Smith & Nephew, Inc. | 24 | 2 |
| Microport Orthopedics, Inc. | 13 | 8 |
| Howmedica Corp. | 19 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2025 | BioPro, 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 |
LZO | K912641 |
| Apr 21, 2025 | Zimmer, 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 |
LZO | K181171 |
| Apr 21, 2025 | Zimmer, 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 |
LZO | K181171 |
| Apr 21, 2025 | Zimmer, 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 |
LZO | K181171 |
| Apr 21, 2025 | Zimmer, 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 |
LZO | K181171 |
| Apr 21, 2025 | Zimmer, 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 |
LZO | K181171 |
| Mar 24, 2025 | Zimmer, Inc. Z1 Femoral Hip System, Product Number 611777612 Open, Classified |
LZO | K233476 |
| Dec 26, 2024 | Waldemar 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 |
LZO | K142187 |
| Sep 12, 2024 | Zimmer 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 |
LZO | K082996 |
| Sep 12, 2024 | Zimmer 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 |
LZO | K082996 |
| May 24, 2024 | Smith & 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 |
LZO | K021673 K022958 |
| Feb 29, 2024 | Waldemar 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 |
LZO | K190535 |
| Dec 18, 2023 | Biomet, Inc. Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02 Open, Classified |
LZO | K200112 |
| Dec 18, 2023 | Biomet, Inc. Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 Open, Classified |
LZO | K200112 |
| Sep 19, 2023 | Encore Medical, LP DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443 Open, Classified |
LZO | K082844 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Aug 4, 2023 | Waldemar 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 |
LZO | K183141 |
| Dec 19, 2022 | Corin Ltd Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615 Open, Classified |
LZO | None listed |
| Dec 19, 2022 | Corin Ltd Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 Open, Classified |
LZO | None listed |
| Aug 11, 2022 | Exactech, 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 |
LZO | K121392 |
| Aug 11, 2022 | Exactech, 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 |
LZO | K070479 |
| Jan 14, 2022 | Howmedica Osteonics Corp. Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm
Catalog Number: 6570-0-232 Open, Classified |
LZO | K052718 |
| Jan 14, 2022 | Howmedica Osteonics Corp. Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm
Catalog Number: 6570-0-032 Open, Classified |
LZO | K052718 |
| Aug 12, 2021 | Exactech, Inc. Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component. Completed |
LZO | K060107 |
| Aug 12, 2021 | Exactech, Inc. Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component. Completed |
LZO | K050398 |
| Jul 22, 2021 | Exactech, 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 |
LZO | K070479 |
| Jul 22, 2021 | Exactech, 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 |
LZO | K121392 |
| Jul 22, 2021 | Exactech, 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 |
LZO | K070479 |
| Jul 22, 2021 | Exactech, 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 |
LZO | K070479 |
| Jul 22, 2021 | Exactech, 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 |
LZO | K070479 |
| Jul 9, 2021 | IMPLANTCAST 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 |
LZO | K163577 |
| Dec 21, 2020 | OMNIlife 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 |
LZO | K111572 |
| Dec 21, 2020 | OMNIlife 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 |
LZO | K111572 |
| Dec 21, 2020 | OMNIlife 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 |
LZO | K111572 |
| Jul 22, 2020 | Smith & 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 |
LZO | K143739 |
| Apr 17, 2020 | Biomet, 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 |
LZO | K051411 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Ceramic Femoral Heads, various sizes, Item Nos. 00877504001
00877504002
00877504003
00877504004 Terminated |
LZO | K071535 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011
00585001201
00585001202
00585001301
00585001302
00585003038
00585003214
00585003217
00585003219
00585003238
00585003246
00585004445 Terminated |
LZO | None listed |
| Oct 10, 2019 | Zimmer 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 |
LZO | K071723 |
| Oct 10, 2019 | Zimmer 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 |
LZO | K110836 |
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