510(k) · Cleared
ClearedEMPOWR Acetabular® Liner Extension
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 Nov 12, 2025 as substantially equivalent to K190057 (Encore Medical L.P., 2019) and 4 other predicates after a 149-day review. Its family tree reaches back 13 generations to 1981.
- Decided
- Nov 12, 2025
- Review
- 149 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K810258 (1981). 168 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations between
- 3 generations backK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- 2 generations backK182099 Delta TT ProLima Corporate S.P.A. · 2018
- 1 generation backK191622 Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A. · 2019
- This deviceK251833 EMPOWR Acetabular® Liner ExtensionEncore Medical L.P. · 2025
Show all 13 generations
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 7 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 6 generations backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
- 5 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- 4 generations backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- 3 generations backK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- 2 generations backK182099 Delta TT ProLima Corporate S.P.A. · 2018
- 1 generation backK191622 Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A. · 2019
- This deviceK251833 EMPOWR Acetabular® Liner ExtensionEncore Medical L.P. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −12 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −11 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −10 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −9 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −8 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −7 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −6 | K082996 | Biolox Delta Option Ceramic Heads | Biomet, Inc. | 2009 | 4 |
| −5 | K093549 | 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M… | Biomet Manufacturing Corp | 2009 | — |
| −4 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| −3 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| −2 | K182099 | Delta TT Pro | Lima Corporate S.P.A. | 2018 | — |
| −1 | K191622 | Delta Multihole TT Pro Acetabular System | Lima Corporate S.P.A. | 2019 | — |
| 0 (this device) | K251833 | EMPOWR Acetabular® Liner Extension | Encore Medical L.P. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 5 | 0 |
| 1994 | 20 | 0 |
| 1995 | 15 | 0 |
| 1996 | 9 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 6 | 0 |
| 2000 | 15 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K190057 | DJO Acetabular SystemSummary page 5…Number: 21 CFR 888.3358 Regulatory Class: II Primary Product Code: LPH Secondary Product Code: OQG III. PREDICATE DEVICE Primary Predicate: EMPOWR Acetabular® System (K190057) Additional Predicates: FMP Extended Liners (K172651); Delta Multihole TT Pro Acetabular System (K191622); ceramys™ femoral head… | 2019 |
| * | K172651 | FMP Extended LinersSummary page 5…Product Code: LPH Secondary Product Code: OQG III. PREDICATE DEVICE Primary Predicate: EMPOWR Acetabular® System (K190057) Additional Predicates: FMP Extended Liners (K172651); Delta Multihole TT Pro Acetabular System (K191622); ceramys™ femoral head system (K241483); Trident Large Diameter Acetabular I… | 2017 |
| * | K191622 | Delta Multihole TT Pro Acetabular SystemSummary page 5…. PREDICATE DEVICE Primary Predicate: EMPOWR Acetabular® System (K190057) Additional Predicates: FMP Extended Liners (K172651); Delta Multihole TT Pro Acetabular System (K191622); ceramys™ femoral head system (K241483); Trident Large Diameter Acetabular Inserts (K062419). IV. DEVICE DESCRIPTION The subje… | 2019 |
| * | K241483 | ceramys™ femoral head systemSummary page 5…POWR Acetabular® System (K190057) Additional Predicates: FMP Extended Liners (K172651); Delta Multihole TT Pro Acetabular System (K191622); ceramys™ femoral head system (K241483); Trident Large Diameter Acetabular Inserts (K062419). IV. DEVICE DESCRIPTION The subject device is a family of highly crosslin… | 2025 |
| * | K062419 | Trident Large Diameter Acetabular InsertsSummary page 5…es: FMP Extended Liners (K172651); Delta Multihole TT Pro Acetabular System (K191622); ceramys™ femoral head system (K241483); Trident Large Diameter Acetabular Inserts (K062419). IV. DEVICE DESCRIPTION The subject device is a family of highly crosslinked (HXL), ultra-high molecular weight polyethylene (… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 44 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 51 of the 168 ancestors have a recall of any class.
- 1 other device also cites its predicate K190057.
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. 2025, 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. This device may also be indicated in the salvage of previously failed surgical attempts. The EMPOWR Dual Mobility™ system has the additional indication of joint replacement due…
Read the full statement (114 words)
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.
This device may also be indicated in the salvage of previously failed surgical attempts.
The EMPOWR Dual Mobility™ system has the additional indication of joint replacement due to dislocation risks.
The constrained acetabular component is indicated for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for who all other options to constrained acetabular components have been considered.
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/K251833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251833: EMPOWR Acetabular® Liner Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251833
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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