510(k) · Cleared
ClearedInterface Acetabular Cup Liners
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 Oct 23, 2009 as substantially equivalent to K031110 (Apex Surgical, LLC, 2003) and 5 other predicates after a 74-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it.
- Decided
- Oct 23, 2009
- Review
- 74 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K930712 (1993). 21 ancestors in all. 1 later device descends from it, 1 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 deviceK092443 Interface Acetabular Cup LinersOmni Life Science, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK171156 OMNI Anseris Hip StemOmnilife Science · 2017
Most influential descendants
Showing 1 of 1 · See all- K171156OMNI Anseris Hip StemOmnilife Science · 2017 · cites it directly0descendants
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) | K092443 | Interface Acetabular Cup Liners | Omni Life Science, Inc. | 2009 | — |
| +1 | K171156 | OMNI Anseris Hip Stem | Omnilife Science | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 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 |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K031110 | Apex Modular Acetabular CupSummary page 2…f 2 510(K) SummARY 5. Predicate Device Comparison Substantial equivalence is claimed to the InterfaceTM (K03 1110), the ApeX-LNK PolyTM (K062489 and K073150), and the Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup… | 2003 |
| * | K062489 | Apex Hcla Acetabular Cup LinersSummary page 2…510(K) SummARY 5. Predicate Device Comparison Substantial equivalence is claimed to the InterfaceTM (K03 1110), the ApeX-LNK PolyTM (K062489 and K073150), and the Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup liners. The following table su… | 2007 |
| * | K073150 | Apex-LNK Poly Acetabular Cup LinersSummary page 2…510(K) SummARY 5. Predicate Device Comparison Substantial equivalence is claimed to the InterfaceTM (K03 1110), the ApeX-LNK PolyTM (K062489 and K073150), and the Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup liners. The following table summarizes the… | 2008 |
| * | K934765 | Trilogy Acetabular SystemSummary page 2…evice Comparison Substantial equivalence is claimed to the InterfaceTM (K03 1110), the ApeX-LNK PolyTM (K062489 and K073150), and the Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup liners. The following table summarizes the similarities and differences between the subject Ape… | 1994 |
| * | K953490 | Trilogy Acetabular Shell & Liners 36MMSummary page 2…parison Substantial equivalence is claimed to the InterfaceTM (K03 1110), the ApeX-LNK PolyTM (K062489 and K073150), and the Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup liners. The following table summarizes the similarities and differences between the subject Apex Modular… | 1995 |
| * | K972774 | Gas Plasma SterilizationSummary page 2…tantial equivalence is claimed to the InterfaceTM (K03 1110), the ApeX-LNK PolyTM (K062489 and K073150), and the Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup liners. The following table summarizes the similarities and differences between the subject Apex Modular InterfaceTM… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 16 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K171156 (Omnilife Science, 2017) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K031110.
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. 2009, 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 InterfaceTM Acetabular Cup Liners are intended for use with the InterfaceTM Acetabular Cup, in combination with the Apex ModularTM, Apex K2TM, or Apex K1TM 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…
Read the full statement (108 words)
The InterfaceTM Acetabular Cup Liners are intended for use with the InterfaceTM Acetabular Cup, in combination with the Apex ModularTM, Apex K2TM, or Apex K1TM 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/K092443 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092443: Interface Acetabular Cup Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092443
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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