510(k) · Cleared
Recalled · Class II · 20122 Piece Modular Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Apr 3, 2002 as substantially equivalent to K983404 (Howmedica Corp., 1998) and 3 other predicates after a 198-day review. Its family tree reaches back 3 generations to 1994. 101 later devices descend from it. It has been recalled 37 times.
- Decided
- Apr 3, 2002
- Review
- 198 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 37
- Predicates
- 4
Its longest line of descent runs back 3 generations to K921308 (1994). 13 ancestors in all. 101 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 2 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 1 generation backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- This deviceK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002
- Descendant · cites it directly · 54 of its ownK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- Descendant · cites it directly · 53 of its ownK103479 Novel Tapered Hip StemStryker Corp. · 2011
- Descendant · cites it directly · 46 of its ownK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
- Descendant · cites it directly · 37 of its ownK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 30 of its ownK123604 Abg Iii Monolithic Hip StemHowmedica Osteonics Corp. · 2013 · Recalled
Showing 5 of 101 descendants. See all descendants
Descendants cleared per year
2002high 12 (2025) · low 0 (2004)2026
Most influential descendants
Showing 5 of 101 · See all- K022549Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · cites it directly54descendants
- K103479Novel Tapered Hip StemStryker Corp. · 2011 · cites it directly53descendants
- K120578Accolade II Hip StemHowmedica Osteonics · 2012 · cites it directly46descendants
- K090757Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · cites it directly37descendants
- K123604Abg Iii Monolithic Hip StemHowmedica Osteonics Corp. · 2013 · 2 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −2 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −1 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| 0 (this device) | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | — |
| +1 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| +1 | K103479 | Novel Tapered Hip Stem | Stryker Corp. | 2011 | — |
| +1 | K120578 | Accolade II Hip Stem | Howmedica Osteonics | 2012 | 1 |
| +1 | K090757 | Biomet Modular Femoral Revision System | Biomet, Inc. | 2009 | 18 |
| +2 | K123604 | Abg Iii Monolithic Hip Stem | Howmedica Osteonics Corp. | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 8 | 0 |
| 2017 | 9 | 0 |
| 2018 | 3 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 12 | 0 |
| 2026 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K983404 | Type 3 Femoral ComponentsSummary page 2…ar Stem is based upon equivalence in intended use, materials, design, and operational principles to the following Howmedica Osteonics devices: Type 3 Femoral Components (K983404); Partnership Revision Femoral Component (K972893); Meridian Titanium Femoral Stems (K972228); and the Citation TMZF HA Femoral S… | 1998 |
| * | K972893 | Partnership Revision Femoral StemsSummary page 2…materials, design, and operational principles to the following Howmedica Osteonics devices: Type 3 Femoral Components (K983404); Partnership Revision Femoral Component (K972893); Meridian Titanium Femoral Stems (K972228); and the Citation TMZF HA Femoral Stem (K993768). TOTAL P.@3 HEALTR… | 1997 |
| * | K972228 | Meridian Titanium Femoral StemsSummary page 2…les to the following Howmedica Osteonics devices: Type 3 Femoral Components (K983404); Partnership Revision Femoral Component (K972893); Meridian Titanium Femoral Stems (K972228); and the Citation TMZF HA Femoral Stem (K993768). TOTAL P.@3 HEALTR s %4, SERVICEg, # % (C DEPARTMENT OF HEAL… | 1997 |
| * | K993768 | Citation TMZF HA StemSummary page 2…Type 3 Femoral Components (K983404); Partnership Revision Femoral Component (K972893); Meridian Titanium Femoral Stems (K972228); and the Citation TMZF HA Femoral Stem (K993768). TOTAL P.@3 HEALTR s %4, SERVICEg, # % (C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Heaith Service (2 &… | 2000 |
What descends from it? (101)
See all 1016 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2012 | Class II | Z-2487-2012 | Device Design | Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and 0.037 mm squared in cross section. |
| Dec 30, 2009 | Not classified | Z-1102-2010 | Process control | The Restoration Modular Hip Stem may have two different package labels. The 14 mm diameter stem may be labeled with both a size 14 mm diameter and a 26 mm diameter. |
| Jun 26, 2009 | Not classified | Z-2174-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2164-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2172-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2148-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2156-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2169-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2159-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2145-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2161-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2178-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2173-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2157-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2175-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2154-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2153-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2149-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2160-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2170-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2162-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2171-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2155-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2168-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2147-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2163-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2152-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2158-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2165-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2166-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2150-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2167-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2177-2009 | Nonconforming Material/Component | Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants. |
| Jun 26, 2009 | Not classified | Z-2151-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Jun 26, 2009 | Not classified | Z-2146-2009 | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by… |
| Apr 2, 2009 | Not classified | Z-1642-2009 | Process control | Packaging burst test values for the Restoration Modular Cone Body family were found to be incorrectly transferred from the finalized validation to the work specification. Testing showed that burst test results for recalled products fell… |
| Dec 30, 2003 | Not classified | Z-0571-04 | Other | Restoration T3 Revision Hip System distal stem has demonstrated fractures. |
The 5 latest of 37 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 7 of the 13 ancestors have a recall of any class.
- Of its descendants, K022549 (Howmedica Osteonics Corp., 2002) has gone furthest, with 54 descendants of its own.
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.
FDA decisions per year · LZO
14in 2025
2007high 28 (2019) · low 7 (2009)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
2007high 279 (2022) · low 63 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
2007high 42 (2009) · low 0 (2010)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
2007high 3,244 (2025) · low 125 (2008)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?
The 2 Piece Modular Revision Stem Components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.
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/K013106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013106: 2 Piece Modular Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013106
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026