510(k) · Cleared
Recalled · Class II · 2026DJO Acetabular System
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 Jun 7, 2019 as substantially equivalent to K072888 (Encore Medical L.P., 2008) and 5 other predicates after a 147-day review. Its family tree reaches back 10 generations to 1981. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 7, 2019
- Review
- 147 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 5
- Predicates
- 6
Its longest line of descent runs back 10 generations to K810258 (1981). 122 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 6 generations between
- 3 generations backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
- 2 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- 1 generation backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- This deviceK190057 DJO Acetabular SystemEncore Medical L.P. · 2019
- Descendant · cites it directly · 0 of its ownK251833 EMPOWR Acetabular® Liner ExtensionEncore Medical L.P. · 2025
- Descendant · cites it directly · 0 of its ownK191708 Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral…Signature Orthopaedics Pty, Ltd. · 2020
Show all 10 generations
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 7 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 6 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 5 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 4 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 3 generations backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
- 2 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- 1 generation backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- This deviceK190057 DJO Acetabular SystemEncore Medical L.P. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −9 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −8 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −7 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −6 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −5 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −4 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −3 | K082996 | Biolox Delta Option Ceramic Heads | Biomet, Inc. | 2009 | 4 |
| −2 | K093549 | 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M… | Biomet Manufacturing Corp | 2009 | — |
| −1 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| 0 (this device) | K190057 | DJO Acetabular System | Encore Medical L.P. | 2019 | — |
| +1 | K251833 | EMPOWR Acetabular® Liner Extension | Encore Medical L.P. | 2025 | — |
| +1 | K191708 | Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head | Signature Orthopaedics Pty, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 17 | 0 |
| 1995 | 13 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 24.2 · 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? (6)
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 |
|---|---|---|---|
| * | K072888 | Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked, Hemispherical and…Summary page 4…em Name Manufacturer 510(k) Clearance FMP Hemispherical Acetabular Shells Encore Medical, L.P. K072888 FMP HXe+ Acetabular Liner Encore Medical, L.P. K130365 FMP HXe+ Extended Acetabular Liner… | 2008 |
| * | K130365 | X-Alt Highly Cross Linked VE Acetabular LinerSummary page 4…FMP Hemispherical Acetabular Shells Encore Medical, L.P. K072888 FMP HXe+ Acetabular Liner Encore Medical, L.P. K130365 FMP HXe+ Extended Acetabular Liner Encore Medical L.P. K172651 Cancellous Bone Screws… | 2013 |
| * | K172651 | FMP Extended LinersSummary page 4…FMP HXe+ Acetabular Liner Encore Medical, L.P. K130365 FMP HXe+ Extended Acetabular Liner Encore Medical L.P. K172651 Cancellous Bone Screws Encore Medical, L.P. K931665 G7 Acetabular System… | 2017 |
| * | K931665 | 6.5 MM Cancellous Bone ScrewSummary page 4…FMP HXe+ Extended Acetabular Liner Encore Medical L.P. K172651 Cancellous Bone Screws Encore Medical, L.P. K931665 G7 Acetabular System Biomet K121874 Trident Acetabular System… | 1994 |
| * | K121874 | G7 Acetabular SystemSummary page 4…Cancellous Bone Screws Encore Medical, L.P. K931665 G7 Acetabular System Biomet K121874 Trident Acetabular System Stryker K040412 Comparable Features to P… | 2012 |
| * | K040412 | Trident T Acetabular ShellsSummary page 4…G7 Acetabular System Biomet K121874 Trident Acetabular System Stryker K040412 Comparable Features to Predicate Device(s): K190057 p. 2/2 Acetabular Cup: Materials, size… | 2004 |
What descends from it? (2)
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 |
|---|---|---|---|---|
| Jan 5, 2026 | Class II | Z-1234-2026 | Labeling Change Control | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices… |
| Aug 22, 2023 | Class II | Z-0103-2024 | Labeling Change Control | Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs… |
| Aug 12, 2022 | Class II | Z-0125-2023 | Process control | Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery. |
| Sep 9, 2020 | Class II | Z-0135-2021 | Employee error | Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly. |
| Oct 22, 2019 | Class II | Z-1929-2020 | Device Design | The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 39 of the 122 ancestors have a recall of any class.
- Of its descendants, K251833 (Encore Medical L.P., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K072888.
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. 2019, 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.
This device is indicated for cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190057: DJO Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190057
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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