510(k) · Cleared
Recalled · Class II · 2018Linear Hip Stem, Size 5
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 Feb 24, 2012 as substantially equivalent to K991325 (Encore Orthopedics, Inc., 1999) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1999. 6 later devices descend from it. It has been recalled once.
- Decided
- Feb 24, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K991325 (1999). 2 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK991325 Modification of Encore Linear Porous Coated HipEncore Orthopedics, Inc. · 1999
- This deviceK120241 Linear Hip Stem, Size 5Encore Medical L.P. · 2012
- 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
- Descendant · cites it directly · 0 of its ownK223779 EMPOWR™ blade stemEncore Medical, LLC · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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
- K223779EMPOWR™ blade stemEncore Medical, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991325 | Modification of Encore Linear Porous Coated Hip | Encore Orthopedics, Inc. | 1999 | — |
| 0 (this device) | K120241 | Linear Hip Stem, Size 5 | Encore Medical L.P. | 2012 | — |
| +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 | — |
| +1 | K223779 | EMPOWR™ blade stem | Encore Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991325 | Modification of Encore Linear Porous Coated HipSummary page 1…femur with head involvement, which is unmanageable using other techniques. This stem is to be press-fit. Predicate Devices: DJO Surgical Linear Hip Stem, Size 5 - K991325 DJO Surgical Porous Coated Hip Stems - KO081679 Comparable Features to Predicate Device(s): Features comparable to predicate… | 1999 |
| * | K081679 | Revelation Hip Stem, Models, 427-01, 427-02; Linear Hip Stem, Models 425-00, 425-05Summary page 1…al Testing: Fatigue testing of the size 5 stem demonstrated the device's ability to perform under expected conditions. Prior testing of the alternate porous coating in K08 1679 included shear strength, tensile strength, shear fatigue strength, and rotating beam fatigue. Clinical Testing: None provide… | 2008 |
What descends from it? (6)
2 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 |
|---|---|---|---|---|
| Jul 10, 2018 | Class II | Z-1692-2020 | Process design | The retaining ring on the neck trials has a potential to fail interoperatively. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2012, 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?
The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. This stem is to be press-fit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120241 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120241: Linear Hip Stem, Size 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120241
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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