510(k) · Cleared
Recalled · 2005Howmedica Asymmetric Stem Femoral Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Mar 22, 1996 after an 87-day review. The FDA summary names its predicate without a number. 241 later devices descend from it. It has been recalled once.
- Decided
- Mar 22, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 0
241 later devices descend from it, 3 citing it directly.
- This deviceK955871 Howmedica Asymmetric Stem Femoral ComponentHowmedica Corp. · 1996
- Descendant · cites it directly · 224 of its ownK993768 Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · Recalled
- Descendant · 2 generations on · 150 of its ownK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
- Descendant · 2 generations on · 101 of its ownK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- Descendant · 3 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- Descendant · 4 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
Showing 5 of 241 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 241 · See all- K993768Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · cites it directly224descendants
- K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000 · 2 generations on150descendants
- K0131062 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · 2 generations on101descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 3 generations on90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 4 generations on83descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955871 | Howmedica Asymmetric Stem Femoral Component | Howmedica Corp. | 1996 | — |
| +1 | K993768 | Citation TMZF HA Stem | Howmedica Osteonics Corp. | 2000 | 12 |
| +2 | K001448 | Trident Acetabular Shells: PS-HA | Howmedica Osteonics Corp. | 2000 | — |
| +2 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| +3 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +4 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 10 | 0 |
| 2013 | 9 | 0 |
| 2014 | 8 | 0 |
| 2015 | 11 | 0 |
| 2016 | 14 | 0 |
| 2017 | 19 | 0 |
| 2018 | 10 | 0 |
| 2019 | 18 | 0 |
| 2020 | 14 | 0 |
| 2021 | 13 | 0 |
| 2022 | 15 | 0 |
| 2023 | 13 | 0 |
| 2024 | 14 | 0 |
| 2025 | 23 | 0 |
| 2026 | 12 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | P.C.A.® E-Series Hip System Named without a submission number | |
| * | — | Straight Stem Femoral Component Named without a submission number | |
| * | — | Anatomic Hip Named without a submission number |
What descends from it? (241)
See all 2413 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 |
|---|---|---|---|---|
| Aug 24, 2005 | Not classified | Z-0109-06 | Other | The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993768 (Howmedica Osteonics Corp., 2000) has gone furthest, with 224 descendants of its own.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
All of the named devices are intended for use in the primary and secondary reconstruction of the head and neck portion of the femur. For the specific indication of primary non~inflammatory degenerative joint disease, the Howmedica® Asymmetric Stem Femoral Component is substantially equivalent to the P.C.A.® E-Series Hip and the Howmedica® Straight Stem Femoral Component.
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/K955871 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955871: Howmedica Asymmetric Stem Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955871
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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