510(k) · Cleared
Recalled · 2005Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating
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 Feb 11, 1998 after a 336-day review. The FDA summary names its predicate without a number. 255 later devices descend from it. It has been recalled once.
- Decided
- Feb 11, 1998
- Review
- 336 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 0
255 later devices descend from it, 5 citing it directly.
- This deviceK971206 Meridian ST Femoral Stem and Vitalock Solid Back Shell W/…Howmedica Corp. · 1998
- Descendant · cites it directly · 216 of its ownK013475 Trident Porous Titanium Acetabular Component with Peri-Apatite CoatingHowmedica Osteonics Corp. · 2001
- Descendant · 2 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- Descendant · 3 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- Descendant · 3 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
Showing 5 of 255 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 255 · See all- K013475Trident Porous Titanium Acetabular Component with Peri-Apatite CoatingHowmedica Osteonics Corp. · 2001 · cites it directly216descendants
- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 2 generations on198descendants
- K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · 3 generations on90descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 3 generations on90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 3 generations on83descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971206 | Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating | Howmedica Corp. | 1998 | — |
| +1 | K013475 | Trident Porous Titanium Acetabular Component with Peri-Apatite Coating | Howmedica Osteonics Corp. | 2001 | — |
| +2 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +3 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| +3 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +3 | 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 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 12 | 0 |
| 2012 | 17 | 0 |
| 2013 | 14 | 0 |
| 2014 | 7 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 15 | 0 |
| 2018 | 10 | 0 |
| 2019 | 11 | 0 |
| 2020 | 12 | 0 |
| 2021 | 19 | 0 |
| 2022 | 19 | 0 |
| 2023 | 16 | 0 |
| 2024 | 17 | 0 |
| 2025 | 22 | 0 |
| 2026 | 21 | 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 24.3 · 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 |
|---|---|---|---|
| * | — | Meridian™ ST Femoral Stem Named without a submission number | |
| * | — | Vitalock® Solid Backed Acetabular Shell Named without a submission number | |
| * | — | Osteolock™ HA Femoral Stem Named without a submission number |
What descends from it? (255)
See all 2555 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013475 | Trident Porous Titanium Acetabular Component with Peri-Apatite Coating | 2001 | 216 |
| K023302 | Echelon Porous Plus HA Hip Stems | 2002 | 25 |
| K101072 | Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite | 2011 | 22 |
| K122158 | PBP Total Hip System | 2012 | 21 |
| K982248 | Howmedica Asymmetric Stem Vitalock Cluster & Spiked Shells, and Acetabular Shells with… | 1998 | 0 |
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-0107-06 | 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, K013475 (Howmedica Osteonics Corp., 2001) has gone furthest, with 216 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?
The Meridian™ ST Femoral Stem and Vitalock® Solid Back Acetabular Shell with Peri-Apatite™ Coating are intended to be used in the primary uncemented reconstruction of the proximal femur and acetabulum damaged as a result of non-inflammatory joint disease, avascular necrosis or trauma.
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/K971206 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971206: Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971206
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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