510(k) · Cleared
ClearedApex Modular Acetabular Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex Surgical, LLC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on May 22, 2003 as substantially equivalent to K000306 (DePuy Orthopaedics, Inc., 2000) and 2 other predicates after a 44-day review. Its family tree reaches back 4 generations to 1993. 217 later devices descend from it.
- Decided
- May 22, 2003
- Review
- 44 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K930712 (1993). 9 ancestors in all. 217 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 3 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 2 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 1 generation backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- This deviceK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
- Descendant · cites it directly · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
- Descendant · 2 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- Descendant · cites it directly · 69 of its ownK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
- Descendant · 3 generations on · 62 of its ownK111911 Corin Optimom Modular HeadCorin USA · 2011
- Descendant · cites it directly · 62 of its ownK073150 Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008
Showing 5 of 217 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 217 · See all- K093472Trinity Acetabular SystemCorin USA · 2010 · cites it directly117descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 2 generations on109descendants
- K060635Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006 · cites it directly69descendants
- K111911Corin Optimom Modular HeadCorin USA · 2011 · 3 generations on62descendants
- K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008 · cites it directly62descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −3 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −2 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −1 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| 0 (this device) | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| +1 | K093472 | Trinity Acetabular System | Corin USA | 2010 | 1 |
| +2 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| +1 | K060635 | Consensus Acetabular Shell System | Hayes Medical, Inc. | 2006 | — |
| +3 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
| +1 | K073150 | Apex-LNK Poly Acetabular Cup Liners | Omni Life Science, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 15 | 0 |
| 2013 | 19 | 0 |
| 2014 | 7 | 0 |
| 2015 | 9 | 0 |
| 2016 | 8 | 0 |
| 2017 | 12 | 0 |
| 2018 | 13 | 0 |
| 2019 | 15 | 0 |
| 2020 | 12 | 0 |
| 2021 | 11 | 0 |
| 2022 | 16 | 0 |
| 2023 | 18 | 0 |
| 2024 | 10 | 0 |
| 2025 | 20 | 0 |
| 2026 | 14 | 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 |
|---|---|---|---|
| * | K000306 | Pinnacle Acetabular SystemSummary page 2…PinnacleTM Lineage Acetabular Cup Acetabular Cup (K000306and (K002149) KO01 534) INTENDED USE Primary and revision… | 2000 |
| * | K001534 | Pinnacle Acetabular System | 2000 |
| * | K002149 | Lineage Acetabular SystemSummary page 2…Lineage Acetabular Cup Acetabular Cup (K000306and (K002149) KO01 534) INTENDED USE Primary and revision Yes, cementless… | 2000 |
What descends from it? (217)
See all 2178 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093472 | Trinity Acetabular System | 2010 | 117 |
| K060635 | Consensus Acetabular Shell System | 2006 | 69 |
| K073150 | Apex-LNK Poly Acetabular Cup Liners | 2008 | 62 |
| K100445 | Klassic HD Hip System | 2010 | 25 |
| K112779 | Apex Modular Acctabular Cup (Now Named Apex Interface Acetabular System) | 2011 | 2 |
| K101976 | Interface Acetabular System, Acetabular Insert +4 Offset | 2010 | 1 |
| K092443 | Interface Acetabular Cup Liners | 2009 | 1 |
| K171156 | OMNI Anseris Hip Stem | 2017 | 0 |
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 4 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K093472 (Corin USA, 2010) has gone furthest, with 117 descendants of its own.
- 17 other devices also cite its predicate K000306.
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 Apex ModularTM Acetabular Cup is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is 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;
Femoral neck and trochanteric fractures of the proximal femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031110: Apex Modular Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031110
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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