510(k) · Cleared
ClearedOMNI Interface Acetabular System
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 Jan 26, 2015 as substantially equivalent to K112779 (Omnlife Science, 2011) and 2 other predicates after a 168-day review. Its family tree reaches back 9 generations to 1993. 1 later device descends from it.
- Decided
- Jan 26, 2015
- Review
- 168 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K930712 (1993). 98 ancestors in all, the oldest K810258 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 5 generations between
- 3 generations backK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
- 2 generations backK122512 CS2 Hip SystemConsensus Orthopedics, Inc. · 2012
- 1 generation backK123782 Paragon Hip SystemGlobal Manufacturing Technology · 2013
- This deviceK142201 OMNI Interface Acetabular SystemOmnlife Science · 2015
- Descendant · cites it directly · 0 of its ownK171156 OMNI Anseris Hip StemOmnilife Science · 2017
Show all 9 generations
- Root · 9 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 8 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 7 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 6 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 5 generations backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
- 4 generations backK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
- 3 generations backK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
- 2 generations backK122512 CS2 Hip SystemConsensus Orthopedics, Inc. · 2012
- 1 generation backK123782 Paragon Hip SystemGlobal Manufacturing Technology · 2013
- This deviceK142201 OMNI Interface Acetabular SystemOmnlife Science · 2015
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 |
|---|---|---|---|---|---|
| −9 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −8 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −7 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −6 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −5 | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| −4 | K060635 | Consensus Acetabular Shell System | Hayes Medical, Inc. | 2006 | — |
| −3 | K102399 | Consensus Taperset Hip System | Consensus Orthopedics, Inc. | 2010 | — |
| −2 | K122512 | CS2 Hip System | Consensus Orthopedics, Inc. | 2012 | — |
| −1 | K123782 | Paragon Hip System | Global Manufacturing Technology | 2013 | — |
| 0 (this device) | K142201 | OMNI Interface Acetabular System | Omnlife Science | 2015 | — |
| +1 | K171156 | OMNI Anseris Hip Stem | Omnilife Science | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 16 | 0 |
| 1995 | 7 | 0 |
| 1996 | 15 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K112779 | Apex Modular Acctabular Cup (Now Named Apex Interface Acetabular System)Summary page 4…3358 Hip joint metal/polymer/metal semi‐ constrained porous‐coated uncemented prosthesis. LPH Predicate Device K112779 Apex Interface Acetabular System K060635 Consensus Acetabular Shell System… | 2011 |
| * | K060635 | Consensus Acetabular Shell SystemSummary page 4…constrained porous‐coated uncemented prosthesis. LPH Predicate Device K112779 Apex Interface Acetabular System K060635 Consensus Acetabular Shell System K123782 Paragon Hip System… | 2006 |
| * | K123782 | Paragon Hip SystemSummary page 4…K112779 Apex Interface Acetabular System K060635 Consensus Acetabular Shell System K123782 Paragon Hip System Reference Predicates:… | 2013 |
| † | K031110 | Apex Modular Acetabular Cup | 2003 |
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 22 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 98 ancestors have a recall of any class.
- Of its descendants, K171156 (Omnilife Science, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112779.
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. 2015, 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 OMNI Interface™ Acetabular System is designed to be used in hip arthroplasty. The specific indications for use include -
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.
The OMNI Interface Acetabular System is intended for cementless and single use implantation only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142201: OMNI Interface Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142201
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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