510(k) · Cleared
ClearedApex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810, 303210,303610,304010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnlife Science · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jun 30, 2010 as substantially equivalent to K000788 (Apex Surgical, LLC, 2000) and 2 other predicates after a 23-day review. Its family tree reaches back 7 generations to 1993. 24 later devices descend from it.
- Decided
- Jun 30, 2010
- Review
- 23 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K930712 (1993). 24 ancestors in all, the oldest K913231 (1991). 24 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 6 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 5 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 4 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 3 generations backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
- 2 generations backK073150 Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008
- 1 generation backK100555 Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc. · 2010 · Recalled
- This deviceK101575 Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models…Omnlife Science · 2010
- Descendant · cites it directly · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
- Descendant · 2 generations on · 14 of its ownK122641 Mpact ExtensionMedacta International · 2012
- Descendant · 2 generations on · 11 of its ownK132879 Mpact ExtensionMedacta International · 2014
- Descendant · 2 generations on · 4 of its ownK183582 MPACT ExtensionMedacta International S.A. · 2019
- Descendant · 2 generations on · 3 of its ownK230011 Mpact ExtensionMedacta International S.A. · 2023
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K103721Mpact Acetabular SystemMedacta International · 2011 · cites it directly21descendants
- K122641Mpact ExtensionMedacta International · 2012 · 2 generations on14descendants
- K132879Mpact ExtensionMedacta International · 2014 · 2 generations on11descendants
- K183582MPACT ExtensionMedacta International S.A. · 2019 · 2 generations on4descendants
- K230011Mpact ExtensionMedacta International S.A. · 2023 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −6 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −5 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −4 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| −2 | K073150 | Apex-LNK Poly Acetabular Cup Liners | Omni Life Science, Inc. | 2008 | — |
| −1 | K100555 | Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK | Omni Life Science, Inc. | 2010 | 1 |
| 0 (this device) | K101575 | Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810… | Omnlife Science | 2010 | — |
| +1 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| +2 | K122641 | Mpact Extension | Medacta International | 2012 | — |
| +2 | K132879 | Mpact Extension | Medacta International | 2014 | — |
| +2 | K183582 | MPACT Extension | Medacta International S.A. | 2019 | — |
| +2 | K230011 | Mpact Extension | Medacta International S.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K000788 | Apex Modular Hip StemSummary page 1…rous-coated uncemented ation Name prosthesis Regulatory Class Class II per 21 CFR §888.3358 Product Code LPH Legally Marketed * K000788 Apex Modular Hip Stem, 28 and 32 mm heads, August 02.2000 Predicate * K073150 ApeX-LNK Poly'T Acetabular Cup Line… | 2000 |
| * | K073150 | Apex-LNK Poly Acetabular Cup LinersSummary page 1…21 CFR §888.3358 Product Code LPH Legally Marketed * K000788 Apex Modular Hip Stem, 28 and 32 mm heads, August 02.2000 Predicate * K073150 ApeX-LNK Poly'T Acetabular Cup Liners and 36 mm Heads, February Device(s) 27, 2008)… | 2008 |
| * | K100555 | Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKSummary page 1…000 Predicate * K073150 ApeX-LNK Poly'T Acetabular Cup Liners and 36 mm Heads, February Device(s) 27, 2008) K100555 ApeX-INK Poly Acetabular Liners and Apex Modular Head, 40mm, March 29, 2010) Device… | 2010 |
What descends from it? (24)
See all 243 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 17 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K103721 (Medacta International, 2011) has gone furthest, with 21 descendants of its own.
- 7 other devices also cite its predicate K000788.
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. 2010, 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 Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetaboular cup are intended for uncemented fixation and single use implantation. These prostheses may be used for the following conditions, as appropriate:
* Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
* Rheumatoid arthritis;
* Cortection of functional deformity;
* Congenital dislocation;
* Revision procedures where other treatments or devices have tailed;
* Femoral neck and trochanteric fractures of the proximal femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101575: Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810, 303210,303610,304010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101575
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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