510(k) · Cleared
ClearedEncompass Hip Stem, Tri-Plus Acetabular Shell, Tri-Plus DCM Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Apr 11, 2005 after a 202-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 44 later devices descend from it.
- Decided
- Apr 11, 2005
- Review
- 202 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
44 later devices descend from it, 2 citing it directly.
- This deviceK042565 Encompass Hip Stem, Tri-Plus Acetabular Shell, Tri-Plus DCM LinerOrtho Development Corp. · 2005
- Descendant · cites it directly · 39 of its ownK072857 Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head +…Medacta International S.A. · 2008 · Recalled
- Descendant · 2 generations on · 22 of its ownK080885 Medacta Total Hip Prosthesis System - Line ExtensionMedacta International S.A. · 2008
- Descendant · 3 generations on · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
- Descendant · 4 generations on · 14 of its ownK122641 Mpact ExtensionMedacta International · 2012
- Descendant · 2 generations on · 12 of its ownK093944 Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra SMedacta International S.A. · 2010 · Recalled
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K072857Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + ApricotMedacta International S.A. · 2008 · cites it directly39descendants
- K080885Medacta Total Hip Prosthesis System - Line ExtensionMedacta International S.A. · 2008 · 2 generations on22descendants
- K103721Mpact Acetabular SystemMedacta International · 2011 · 3 generations on21descendants
- K122641Mpact ExtensionMedacta International · 2012 · 4 generations on14descendants
- K093944Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra SMedacta International S.A. · 2010 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042565 | Encompass Hip Stem, Tri-Plus Acetabular Shell, Tri-Plus DCM Liner | Ortho Development Corp. | 2005 | — |
| +1 | K072857 | Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot | Medacta International S.A. | 2008 | 1 |
| +2 | K080885 | Medacta Total Hip Prosthesis System - Line Extension | Medacta International S.A. | 2008 | — |
| +3 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| +4 | K122641 | Mpact Extension | Medacta International | 2012 | — |
| +2 | K093944 | Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra S | Medacta International S.A. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (44)
See all 442 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, K072857 (Medacta International S.A., 2008) has gone furthest, with 39 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 device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only.
1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
2. Previously failed surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042565 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042565: Encompass Hip Stem, Tri-Plus Acetabular Shell, Tri-Plus DCM Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042565
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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