510(k) · Cleared
Recalled · Class II · 2023Zimmer Hip Joint Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Apr 10, 2020 as substantially equivalent to K191781 (Zimmer GmbH, 2019) and 4 other predicates after an 84-day review. Its family tree reaches back 9 generations to 1994. It has been recalled 2 times.
- Decided
- Apr 10, 2020
- Review
- 84 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 9 generations to K921308 (1994). 118 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 9 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 5 generations between
- 3 generations backK113556 Wagner Cone Prosthesis SystemZimmer GmbH · 2012 · Recalled
- 2 generations backK161192 Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH · 2016
- 1 generation backK191781 Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemZimmer GmbH · 2019
- This deviceK200112 Zimmer Hip Joint ReplacementZimmer GmbH · 2020
Show all 9 generations
- Root · 9 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 8 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 7 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 6 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 5 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- 4 generations backK032380 Wagner Cone ProsthesisCenterpulse Orthopedics, Inc. · 2003
- 3 generations backK113556 Wagner Cone Prosthesis SystemZimmer GmbH · 2012 · Recalled
- 2 generations backK161192 Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH · 2016
- 1 generation backK191781 Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemZimmer GmbH · 2019
- This deviceK200112 Zimmer Hip Joint ReplacementZimmer GmbH · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −8 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −7 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −6 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −5 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| −4 | K032380 | Wagner Cone Prosthesis | Centerpulse Orthopedics, Inc. | 2003 | — |
| −3 | K113556 | Wagner Cone Prosthesis System | Zimmer GmbH | 2012 | 1 |
| −2 | K161192 | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System | Zimmer GmbH | 2016 | — |
| −1 | K191781 | Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System | Zimmer GmbH | 2019 | — |
| 0 (this device) | K200112 | Zimmer Hip Joint Replacement | Zimmer GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 11 | 0 |
| 1995 | 10 | 0 |
| 1996 | 13 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2013 | 2 | 0 |
| 2019 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191781 | Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemSummary page 11…Calcium Phosphate (21 CFR §888.3353). Predicate Devices: Wagner SL Revision Stem Lateral, manufactured by Zimmer GmbH, K191781, cleared August 06, 2019 Wagner Cone Prosthesis System, manufactured by Zimmer GmbH… | 2019 |
| * | K192416 | BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemSummary page 11…GmbH, K191781, cleared August 06, 2019 Biolox Delta Ceramic Femoral Heads, manufactured by Zimmer GmbH, K192416, cleared October 01, 2019 Biolox Option Ceramic Femoral Head System, manufactured by… | 2019 |
| * | K192236 | Fitmore Hip StemSummary page 11…Head System, manufactured by Zimmer GmbH, K192416, cleared October 01, 2019 Fitmore® Hip Stem, manufactured by Zimmer GmbH, K192236, cleared November 5, 2019… | 2019 |
| * | K193030 | Avenir Muller Stem, Avenir Cemented Hip StemSummary page 12…K200112 Page 1 of 5 Avenir® Cemented Hip Stem, manufactured by Zimmer GmbH, K193030, cleared December 6, 2019 Avenir® Müller Stem, manufactured by Zimmer GmbH, K193030,… | 2019 |
| * | K193050 | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral StemSummary page 12…030, cleared December 6, 2019 Alloclassic® Zweymüller® SL Femoral Stem, manufactured by Zimmer GmbH, K193050, cleared December 26, 2019 Alloclassic® Zweymüller® SL Offset Femoral Stem, manufactured… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2023 | Class II | Z-0570-2024 | Under Investigation by firm | One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The… |
| Nov 2, 2023 | Class II | Z-0569-2024 | Under Investigation by firm | One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 35 of the 118 ancestors have a recall of any class.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (1JD), e.g., rheumatoid arthritis. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of: Advanced wear of the joint due to…
Read the full statement (507 words)
Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (1JD), e.g., rheumatoid arthritis.
Failed previous surgery where pain, deformity, or dysfunction persists.
Revision of previously failed hip arthroplasty
The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:
Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases
Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR)
Acute traumatic fracture of the femoral head or neck
Avascular necrosis of the femoral head.
Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists.
Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Acute traumatic fracture of the femoral head or neck.
Avascular necrosis of the femoral head.
Avenir® Miiller Stems are for cementless use only.
The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following:
Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity.
Patients with acute femoral neck fractures.
The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:
Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
Patients suffering from disability due to previous fusion.
Patients with previously failed endoprostheses and/or total hip components in the operative extremity.
Patients with acute neck fractures.
This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
Noninflammatory degenerative joint disease (NIDJD), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (1JD), e. g., rheumatoid arthritis.
Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.
Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.
This stem is for uncemented use only.
Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (1JD), e.g., rheumatoid arthritis.
Failed previous surgery where pain, deformity, or dysfunction persists.
Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Revision of previously failed hip arthroplasty
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200112: Zimmer Hip Joint Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200112
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026