510(k) · Cleared
Recalled · Class II · 2019Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omni Life Science, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Mar 29, 2010 as substantially equivalent to K073150 (Omni Life Science, Inc., 2008) and 1 other predicate after a 28-day review. Its family tree reaches back 6 generations to 1993. 34 later devices descend from it. It has been recalled once.
- Decided
- Mar 29, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K930712 (1993). 23 ancestors in all, the oldest K913231 (1991). 34 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 5 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 4 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 3 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 2 generations backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
- 1 generation backK073150 Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008
- This deviceK100555 Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc. · 2010
- Descendant · cites it directly · 24 of its ownK101575 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
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science · 2010 · cites it directly24descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −5 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −4 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −3 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| −1 | K073150 | Apex-LNK Poly Acetabular Cup Liners | Omni Life Science, Inc. | 2008 | — |
| 0 (this device) | K100555 | Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK | Omni Life Science, Inc. | 2010 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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? (2)
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 |
|---|---|---|---|
| * | K073150 | Apex-LNK Poly Acetabular Cup LinersSummary page 2…X-LNK ApeX-LNK _________________________ (subject device) (K(073150) Modular liner in metal shell, Yes, cementless Yes, ce… | 2008 |
| * | K000788 | Apex Modular Hip StemSummary page 2…moral Apex Modular Femoral Heads _______________________ Heads (subject device) (K(000788) Inten'ded Use' cc- t§ d¼C.- -Yc… | 2000 |
What descends from it? (34)
See all 345 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101575 | Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810… | 2010 | 24 |
| K103721 | Mpact Acetabular System | 2011 | 21 |
| K101451 | Apex Module Hip System Biolox Delta Femoral Head | 2010 | 4 |
| K142675 | CI../..X liner for NOVAE Dual Mobility Acetabular Cup | 2015 | 3 |
| K101976 | Interface Acetabular System, Acetabular Insert +4 Offset | 2010 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 23, 2019 | Class II | Z-2481-2019 | Nonconforming Material/Component | Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K101575 (Omnlife Science, 2010) has gone furthest, with 24 descendants of its own.
- 6 other devices also cite its predicate K073150.
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 and revision total hip replacement. The femoral hip stem and acetabular cup are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup Liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2 or Apex K1 Hip in total hip replacement procedures. The acetabular cup liners are intended to articulate…
Read the full statement (140 words)
The Apex Hip System is intended for primary and revision total hip replacement. The femoral hip stem and acetabular cup are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup Liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2 or Apex K1 Hip in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for total hip arthroplasty to treat 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/K100555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100555: Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100555
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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