510(k) · Cleared
Recalled · 2003Type 3 Femoral Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Dec 22, 1998 as substantially equivalent to K972893 (Howmedica Corp., 1997) and 2 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1994. 102 later devices descend from it. It has been recalled once.
- Decided
- Dec 22, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K921308 (1994). 7 ancestors in all. 102 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 1 generation backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- This deviceK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998
- Descendant · cites it directly · 101 of its ownK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- Descendant · 2 generations on · 54 of its ownK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- Descendant · 2 generations on · 53 of its ownK103479 Novel Tapered Hip StemStryker Corp. · 2011
- Descendant · 2 generations on · 46 of its ownK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
- Descendant · 2 generations on · 37 of its ownK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K0131062 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · cites it directly101descendants
- K022549Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · 2 generations on54descendants
- K103479Novel Tapered Hip StemStryker Corp. · 2011 · 2 generations on53descendants
- K120578Accolade II Hip StemHowmedica Osteonics · 2012 · 2 generations on46descendants
- K090757Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · 2 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −1 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| 0 (this device) | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | — |
| +1 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| +2 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| +2 | K103479 | Novel Tapered Hip Stem | Stryker Corp. | 2011 | — |
| +2 | K120578 | Accolade II Hip Stem | Howmedica Osteonics | 2012 | 1 |
| +2 | K090757 | Biomet Modular Femoral Revision System | Biomet, Inc. | 2009 | 18 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 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 |
|---|---|---|---|
| * | K972893 | Partnership Revision Femoral StemsSummary page 1…ts is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Howmedica's Partnership™ Revision Femoral Components (K972893) and Modular Replacement System (K954559), Intermedics Orthopedics’ Wagner Revision Stem (K960588) and Link’'s MP Reconstruction… | 1997 |
| * | K954559 | Howmedicca Modular Proximal Humerus Replacement SystemSummary page 1…use, materials, design, and relative indications and contraindications to Howmedica's Partnership™ Revision Femoral Components (K972893) and Modular Replacement System (K954559), Intermedics Orthopedics’ Wagner Revision Stem (K960588) and Link’'s MP Reconstruction Hip System. Testing has demonstrated tha… | 1996 |
| * | K960588 | Wagner Revision StemSummary page 1…traindications to Howmedica's Partnership™ Revision Femoral Components (K972893) and Modular Replacement System (K954559), Intermedics Orthopedics’ Wagner Revision Stem (K960588) and Link’'s MP Reconstruction Hip System. Testing has demonstrated that the fatigue load carrying capacity of the Type 3 Femora… | 1996 |
| * | — | MP Reconstruction Hip System Named without a submission number |
What descends from it? (102)
See all 1021 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013106 | 2 Piece Modular Hip Stem | 2002 | 101 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 30, 2003 | Not classified | Z-0571-04 | Other | Restoration T3 Revision Hip System distal stem has demonstrated fractures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K013106 (Howmedica Osteonics Corp., 2002) has gone furthest, with 101 descendants of its own.
- 4 other devices also cite its predicate K972893.
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
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?
The Type 3 Femoral Components are intended to be used in primary or revision total hip arthroplasty, specifically in the presence of severe proximal bone loss. These stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica 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/K983404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983404: Type 3 Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983404
Report an extraction error
Are you the manufacturer?
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