510(k) · Cleared
Recalled · Class II · 2018Interface Acetabular System, Acetabular Insert +4 Offset
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 Sep 14, 2010 as substantially equivalent to K031110 (Apex Surgical, LLC, 2003) and 3 other predicates after a 63-day review. Its family tree reaches back 7 generations to 1993. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 14, 2010
- Review
- 63 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 7 generations to K930712 (1993). 24 ancestors in all, the oldest K913231 (1991). 1 later device descends from it, 1 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 deviceK101976 Interface Acetabular System, Acetabular Insert +4 OffsetOmni Life Science, Inc. · 2010
- 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 |
|---|---|---|---|---|---|
| −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) | K101976 | Interface Acetabular System, Acetabular Insert +4 Offset | Omni Life Science, Inc. | 2010 | — |
| +1 | K171156 | OMNI Anseris Hip Stem | Omnilife Science | 2017 | — |
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 |
|---|---|---|
| 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? (4)
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 1…uncemented prosthesis Regulatory Class Class II per 21 CFR §888.3358 Product Code LPH Legally Marketed a K031110 Apex Modular Acetabular Cup, May 22, 2003 Predicate * K(062489 Apex HCLA Acetabular Cup Liners August 1… | 2003 |
| * | K062489 | Apex Hcla Acetabular Cup LinersSummary page 2…UHMWPE UHMWPE (K031110) (K062489, _____________K073150,K1100555)… | 2007 |
| * | K073150 | Apex-LNK Poly Acetabular Cup LinersSummary page 1…Modular Acetabular Cup, May 22, 2003 Predicate * K(062489 Apex HCLA Acetabular Cup Liners August 15, 2007 Device(s) * K073150 ApeX-INK Poly"T Acetabular Cup Liners 1(K100555 ApeX-LNK PolyT~A Acetabular Cup Liners, Mar… | 2008 |
| * | K100555 | Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKSummary page 1…ex HCLA Acetabular Cup Liners August 15, 2007 Device(s) * K073150 ApeX-INK Poly"T Acetabular Cup Liners 1(K100555 ApeX-LNK PolyT~A Acetabular Cup Liners, March 29, 2010 Device Non hooded (0 deg neutral) and Hooded (10… | 2010 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2018 | Class II | Z-2540-2018 | Employee error | The Internal packaging, the pouch and patient labels are improperly labeled. |
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 2.1 years on median.
- 2 of the 24 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. 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 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, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are…
Read the full statement (139 words)
The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems 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, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses 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 prbximal femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101976: Interface Acetabular System, Acetabular Insert +4 Offset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101976
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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