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)
Jul 23, 2019OMNIlife science Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
Terminated
LZOK111572
Jul 23, 2019OMNIlife science Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
Terminated
LZOK111572
Dec 7, 2018Waldemar Link GmbH & Co. KG (Mfg Site)
LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK STEM with Microporous Surface MP Recons
Terminated
LZOK142187
Oct 31, 2018Zimmer GmbH
Avenir Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cemen
Terminated
LZOK123392
Mar 29, 2018Zimmer Biomet, Inc.
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss as
Terminated
LZOK101296
Feb 28, 2018Zimmer GmbH
Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
Terminated
LZOK123392
Feb 28, 2018Zimmer GmbH
Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
Terminated
LZOK123392
Dec 28, 2017IMPLANTCAST GMBH
2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 0242444
Terminated
LZONone listed
Nov 15, 2017Medacta Usa Inc
Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Terminated
LZOK170845
Aug 29, 2017Smith & Nephew, Inc.
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 75102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem im
Terminated
LZOK130728
Jun 30, 2017Zimmer Biomet, Inc.
JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty
Terminated
LZOK131684
Jun 30, 2017Zimmer Biomet, Inc.
DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty
Terminated
LZOK131684
Jun 5, 2017Zimmer Biomet, Inc.
CER BIOLOXD OPTION HD 32MM, model # 650-1056
Terminated
LZOK082996
Jun 5, 2017Zimmer Biomet, Inc.
CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
Terminated
LZOK082996
Mar 20, 2017Zimmer Biomet, Inc.
Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Specific Knee, Hip and Nail Implants
Terminated
LZOK081860
Jan 3, 2017MicroPort Orthopedics Inc.
PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for prep
Terminated
LZOK012091
Dec 1, 2016MicroPort Orthopedics Inc.
Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 26000027, 26000028 Conserve: 38013800, 38013804, 38013835, 38
Terminated
LZOK100866
Dec 1, 2016MicroPort Orthopedics Inc.
Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP, REF 38BF4652, REF 38BF4652SP, REF
Terminated
LZOK100866
Dec 1, 2016MicroPort Orthopedics Inc.
Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844,
Terminated
LZOK100866
Dec 1, 2016MicroPort Orthopedics Inc.
Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For use with the conserve metal head
Terminated
LZOK100866
Dec 1, 2016MicroPort Orthopedics Inc.
Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 For use with the conserve metal head
Terminated
LZOK100866
Dec 1, 2016MicroPort Orthopedics Inc.
Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DLCOGK56, For use with the conserve metal head
Terminated
LZOK100866
Dec 1, 2016MicroPort Orthopedics Inc.
Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head
Terminated
LZOK100866
Nov 7, 2016Exactech, Inc.
Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
Terminated
LZOK141821
Jul 26, 2016Zimmer Gmbh
Avenir Mller Stem 4 Standard Avenir Mller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to
Terminated
LZOK123392
May 26, 2016Exactech, Inc.
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip
Terminated
LZOK063279
May 26, 2016Exactech, Inc.
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary su
Terminated
LZOK063279
Jan 29, 2016Corin USA Limited
Trinity Acetabular Shell Product Usage Total Hip Replacement.
Terminated
LZOK123705
Jan 29, 2016Corin USA Limited
Trinity Acetabular Shell Product Usage: Total Hip Replacement.
Terminated
LZOK123705
Jan 29, 2016Corin USA Limited
Trinity Acetabular System Product Usage - Total Hip Replacement.
Terminated
LZOK123705
Jan 13, 2016Biomet, Inc.
Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
Terminated
LZOK942479
Jul 14, 2015Omnilife Science Inc.
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is
Terminated
LZOK090845
Feb 27, 2015Zimmer, Inc.
Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
Terminated
LZOK101296
Feb 20, 2015Zimmer Gmbh
Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck l
Terminated
LZOK071535
Dec 17, 2014DePuy Orthopaedics, Inc.
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip
Terminated
LZOK071830
Aug 15, 2014Omnilife Science Inc.
Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
Terminated
LZOK090845
Jul 21, 2014Exactech, Inc.
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
Terminated
LZOK042843
May 24, 2013Orthopedic Alliance LLC
Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball He
Terminated
LZOK112463
May 24, 2013Orthopedic Alliance LLC
Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller Type Stem SCS-Standard Sz 2 Zweimueller Type Stem SCS-Standard Sz
Terminated
LZOK110245
Feb 5, 2013Exactech, Inc.
Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
Terminated
LZOK070479
Feb 5, 2013Exactech, Inc.
Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
Terminated
LZOK070479
Nov 6, 2012Zimmer, Inc.
MS-30 Shaft, Sterile, Rx
Terminated
LZOK040803
Nov 6, 2012Zimmer, Inc.
CLS Stem
Terminated
LZOK042249
Nov 6, 2012Zimmer, Inc.
Wagner cone Prosthesis, uncemented, sterile, Rx
Terminated
LZOK113556
Nov 6, 2012Zimmer, Inc.
MS-30 Proximal positioner
Terminated
LZOK020713
Nov 6, 2012Zimmer, Inc.
MS-30 Distal centralizer, cemented, sterile, Rx
Terminated
LZONone listed
Nov 6, 2012Zimmer, Inc.
MS-30 Stem
Terminated
LZOK040803
Nov 6, 2012Zimmer, Inc.
Alloclassic SL-Offset Stem sterile, Rx
Terminated
LZOK033664
Nov 6, 2012Zimmer, Inc.
Wagner SL Revision Stem, uncemented Sterile
Terminated
LZOK871347
Nov 6, 2012Zimmer, Inc.
Biolox Option Ceramic Femoral Head System Rx, sterile
Terminated
LZOK073567

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