510(k) · Cleared
ClearedApex Hcla Acetabular Cup Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnilife Science · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Aug 15, 2007 as substantially equivalent to K994415 (DePuy Orthopaedics, Inc., 2000) and 2 other predicates after a 355-day review. Its family tree reaches back 2 generations to 1997. 63 later devices descend from it.
- Decided
- Aug 15, 2007
- Review
- 355 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K972596 (1997). 4 ancestors in all. 63 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK972596 Depuy Duraloc Acetabular Cup SystemDepuy, Inc. · 1997
- 1 generation backK994415 Marathon Cross-Linked Polyethylene Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2000
- This deviceK062489 Apex Hcla Acetabular Cup LinersOmnilife Science · 2007
- Descendant · cites it directly · 62 of its ownK073150 Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008
- Descendant · 2 generations on · 34 of its ownK100555 Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc. · 2010 · Recalled
- Descendant · cites it directly · 25 of its ownK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- Descendant · 2 generations on · 24 of its ownK101575 Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models…Omnlife Science · 2010
- Descendant · 3 generations on · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008 · cites it directly62descendants
- K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc. · 2010 · 2 generations on34descendants
- K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010 · cites it directly25descendants
- K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science · 2010 · 2 generations on24descendants
- K103721Mpact Acetabular SystemMedacta International · 2011 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972596 | Depuy Duraloc Acetabular Cup System | Depuy, Inc. | 1997 | — |
| −1 | K994415 | Marathon Cross-Linked Polyethylene Acetabular Cup Liners | DePuy Orthopaedics, Inc. | 2000 | — |
| 0 (this device) | K062489 | Apex Hcla Acetabular Cup Liners | Omnilife Science | 2007 | — |
| +1 | K073150 | Apex-LNK Poly Acetabular Cup Liners | Omni Life Science, Inc. | 2008 | — |
| +2 | K100555 | Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK | Omni Life Science, Inc. | 2010 | 1 |
| +1 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| +2 | K101575 | Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810… | Omnlife Science | 2010 | — |
| +3 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 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? (3)
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 |
|---|---|---|---|
| * | K994415 | Marathon Cross-Linked Polyethylene Acetabular Cup LinersSummary page 2…510(K) SUMMARY 5. Predicate Device Comparison Substantial equivalence' is claimed to the DePuy MarathonTM Cross-Linked Polyethylene Acetabular Cup Liners (K994415, K010171, and K033273). The following table summarizes the similarities and differences between the subject Apex HCLATM Acetabula… | 2000 |
| * | K010171 | Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene LinerSummary page 2…510(K) SUMMARY 5. Predicate Device Comparison Substantial equivalence' is claimed to the DePuy MarathonTM Cross-Linked Polyethylene Acetabular Cup Liners (K994415, K010171, and K033273). The following table summarizes the similarities and differences between the subject Apex HCLATM Acetabular Cup Lin… | 2001 |
| * | K033273 | Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima…Summary page 2…MARY 5. Predicate Device Comparison Substantial equivalence' is claimed to the DePuy MarathonTM Cross-Linked Polyethylene Acetabular Cup Liners (K994415, K010171, and K033273). The following table summarizes the similarities and differences between the subject Apex HCLATM Acetabular Cup Liners and the p… | 2004 |
| † | K031110 | Apex Modular Acetabular Cup | 2003 |
What descends from it? (63)
See all 635 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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K073150 (Omni Life Science, Inc., 2008) has gone furthest, with 62 descendants of its own.
- 6 other devices also cite its predicate K994415.
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. 2007, 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 Apex HCLA Acetabular Cup Liners are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, or Apex K1 Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate: · Non-inflammatory…
Read the full statement (111 words)
The Apex HCLA Acetabular Cup Liners are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, or Apex K1 Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:
· Non-inflammatory degenerative joint disease, including osteoarthritis and
avascular necrosis;
* Rheumatoid arthritis;
* Correction of functional deformity;
• Congenital dislocation:
* Revision procedures where other treatments or devices have failed:
* Femnoral neck and trochanteric fractures of the proximal femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062489: Apex Hcla Acetabular Cup Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062489
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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