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) |
|---|---|---|---|
| Jul 23, 2019 | OMNIlife science Inc. OMNIlife science, Inc.
ApeX acetabular liner
hip prosthesis component
Serf Dual Mobility Cup Insert Liner 51-28;
Product code: H6-25128 Terminated |
LZO | K111572 |
| Jul 23, 2019 | OMNIlife science Inc. OMNIlife science, Inc.
ApeX acetabular liner
hip prosthesis component
Serf Dual Mobility Cup Liner 53-28;
Product code: H6-25328 Terminated |
LZO | K111572 |
| Dec 7, 2018 | Waldemar 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 |
LZO | K142187 |
| Oct 31, 2018 | Zimmer 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 |
LZO | K123392 |
| Mar 29, 2018 | Zimmer 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 |
LZO | K101296 |
| Feb 28, 2018 | Zimmer GmbH Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496 Terminated |
LZO | K123392 |
| Feb 28, 2018 | Zimmer GmbH Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368 Terminated |
LZO | K123392 |
| Dec 28, 2017 | IMPLANTCAST 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 |
LZO | None listed |
| Nov 15, 2017 | Medacta 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 |
LZO | K170845 |
| Aug 29, 2017 | Smith & 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 |
LZO | K130728 |
| Jun 30, 2017 | Zimmer Biomet, Inc. JUGGERKNOT 2.9MM 2 #2 MB
Product Usage:
For use in hip arthroplasty Terminated |
LZO | K131684 |
| Jun 30, 2017 | Zimmer Biomet, Inc. DELTA CER FEM HD 32/0MM T1
Product Usage:
For use in hip arthroplasty Terminated |
LZO | K131684 |
| Jun 5, 2017 | Zimmer Biomet, Inc. CER BIOLOXD OPTION HD 32MM, model # 650-1056 Terminated |
LZO | K082996 |
| Jun 5, 2017 | Zimmer Biomet, Inc. CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064 Terminated |
LZO | K082996 |
| Mar 20, 2017 | Zimmer 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 |
LZO | K081860 |
| Jan 3, 2017 | MicroPort 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 |
LZO | K012091 |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Cobalt Chromium Heads
Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 26000027, 26000028
Conserve:
38013800, 38013804, 38013835, 38 Terminated |
LZO | K100866 |
| Dec 1, 2016 | MicroPort 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 |
LZO | K100866 |
| Dec 1, 2016 | MicroPort 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 |
LZO | K100866 |
| Dec 1, 2016 | MicroPort 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 |
LZO | K100866 |
| Dec 1, 2016 | MicroPort 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 |
LZO | K100866 |
| Dec 1, 2016 | MicroPort 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 |
LZO | K100866 |
| Dec 1, 2016 | MicroPort 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 |
LZO | K100866 |
| Nov 7, 2016 | Exactech, Inc. Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6 Terminated |
LZO | K141821 |
| Jul 26, 2016 | Zimmer 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 |
LZO | K123392 |
| May 26, 2016 | Exactech, 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 |
LZO | K063279 |
| May 26, 2016 | Exactech, 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 |
LZO | K063279 |
| Jan 29, 2016 | Corin USA Limited Trinity Acetabular Shell
Product Usage Total Hip Replacement. Terminated |
LZO | K123705 |
| Jan 29, 2016 | Corin USA Limited Trinity Acetabular Shell
Product Usage: Total Hip Replacement. Terminated |
LZO | K123705 |
| Jan 29, 2016 | Corin USA Limited Trinity Acetabular System
Product Usage - Total Hip Replacement. Terminated |
LZO | K123705 |
| Jan 13, 2016 | Biomet, Inc. Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo),
9mm, 11mm, 13mm, 15mm, and 17mm Terminated |
LZO | K942479 |
| Jul 14, 2015 | Omnilife 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 |
LZO | K090845 |
| Feb 27, 2015 | Zimmer, 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 |
LZO | K101296 |
| Feb 20, 2015 | Zimmer 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 |
LZO | K071535 |
| Dec 17, 2014 | DePuy 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 |
LZO | K071830 |
| Aug 15, 2014 | Omnilife Science Inc. Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA Terminated |
LZO | K090845 |
| Jul 21, 2014 | Exactech, 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 |
LZO | K042843 |
| May 24, 2013 | Orthopedic 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 |
LZO | K112463 |
| May 24, 2013 | Orthopedic 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 |
LZO | K110245 |
| Feb 5, 2013 | Exactech, 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 |
LZO | K070479 |
| Feb 5, 2013 | Exactech, 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 |
LZO | K070479 |
| Nov 6, 2012 | Zimmer, Inc. MS-30 Shaft, Sterile, Rx Terminated |
LZO | K040803 |
| Nov 6, 2012 | Zimmer, Inc. CLS Stem Terminated |
LZO | K042249 |
| Nov 6, 2012 | Zimmer, Inc. Wagner cone Prosthesis, uncemented, sterile, Rx Terminated |
LZO | K113556 |
| Nov 6, 2012 | Zimmer, Inc. MS-30 Proximal positioner Terminated |
LZO | K020713 |
| Nov 6, 2012 | Zimmer, Inc. MS-30 Distal centralizer, cemented, sterile, Rx Terminated |
LZO | None listed |
| Nov 6, 2012 | Zimmer, Inc. MS-30 Stem Terminated |
LZO | K040803 |
| Nov 6, 2012 | Zimmer, Inc. Alloclassic SL-Offset Stem
sterile, Rx Terminated |
LZO | K033664 |
| Nov 6, 2012 | Zimmer, Inc. Wagner SL Revision Stem, uncemented
Sterile Terminated |
LZO | K871347 |
| Nov 6, 2012 | Zimmer, Inc. Biolox Option Ceramic Femoral Head System
Rx, sterile Terminated |
LZO | K073567 |
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