510(k) · Cleared
ClearedRevelation Hip Stem, Models, 427-01, 427-02; Linear Hip Stem, Models 425-00, 425-05
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Aug 20, 2008 after a 64-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 8 later devices descend from it.
- Decided
- Aug 20, 2008
- Review
- 64 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
8 later devices descend from it, 3 citing it directly.
- This deviceK081679 Revelation Hip Stem, Models, 427-01, 427-02; Linear Hip Stem, Models…Encore Medical L.P. · 2008
- Descendant · cites it directly · 6 of its ownK120241 Linear Hip Stem, Size 5Encore Medical L.P. · 2012 · Recalled
- Descendant · cites it directly · 4 of its ownK130099 Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019Encore Medical L.P. · 2013
- Descendant · 2 generations on · 1 of its ownK223103 BethaLoc® stem cementless HAImplantcast GmbH · 2023
- Descendant · 2 generations on · 1 of its ownK161610 EXPRT Revision Hip SystemEncore Medical L.P. · 2016
- Descendant · 3 generations on · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K120241Linear Hip Stem, Size 5Encore Medical L.P. · 2012 · cites it directly6descendants
- K130099Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019Encore Medical L.P. · 2013 · cites it directly4descendants
- K223103BethaLoc® stem cementless HAImplantcast GmbH · 2023 · 2 generations on1descendant
- K161610EXPRT Revision Hip SystemEncore Medical L.P. · 2016 · 2 generations on1descendant
- K260037implantcast Packaging System UpdateImplantcast GmbH · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081679 | Revelation Hip Stem, Models, 427-01, 427-02; Linear Hip Stem, Models 425-00… | Encore Medical L.P. | 2008 | — |
| +1 | K120241 | Linear Hip Stem, Size 5 | Encore Medical L.P. | 2012 | 1 |
| +1 | K130099 | Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019 | Encore Medical L.P. | 2013 | — |
| +2 | K223103 | BethaLoc® stem cementless HA | Implantcast GmbH | 2023 | — |
| +2 | K161610 | EXPRT Revision Hip System | Encore Medical L.P. | 2016 | — |
| +3 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 1 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K073685 | FDA’s K073685 is Ota Collagen Biomaterial Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| Kept off the family tree | K074894 | Linear® Hip Stem Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (8)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K120241 (Encore Medical L.P., 2012) has gone furthest, with 6 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. 2008, this device’s year, is highlighted.
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?
Joint replacement is indicated for patients suffering from disability due to:
• noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
• rheumatoid arthritis;
• correction of functional deformity;
• femoral fracture
These devices may also be indicated in the salvage of previously failed surgical attempts.
Both the Revelation and Linear hip stems are designed for a cementless application.
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/K081679 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081679: Revelation Hip Stem, Models, 427-01, 427-02; Linear Hip Stem, Models 425-00, 425-05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081679
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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