510(k) · Cleared
ClearedApex Arc Hip Stem
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 Jan 5, 2012 as substantially equivalent to K090845 (Omni Life Science, Inc., 2010) and 1 other predicate after a 64-day review. Its family tree reaches back 12 generations to 1994. 52 later devices descend from it.
- Decided
- Jan 5, 2012
- Review
- 64 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K941847 (1994). 119 ancestors in all, the oldest K810258 (1981). 52 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 8 generations between
- 3 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 2 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 1 generation backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- This deviceK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- Descendant · cites it directly · 48 of its ownK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- Descendant · 2 generations on · 38 of its ownK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 27 of its ownK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- Descendant · 3 generations on · 26 of its ownK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
- Descendant · 3 generations on · 20 of its ownK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
Show all 12 generations
- Root · 12 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 11 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 10 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 9 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 8 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 7 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 6 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 5 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 4 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 3 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 2 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 1 generation backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- This deviceK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · cites it directly48descendants
- K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · 2 generations on38descendants
- K170339Summit Hip SystemDePuy Orthopaedics, Inc. · 2018 · 2 generations on27descendants
- K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016 · 3 generations on26descendants
- K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020 · 3 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −11 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −10 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −9 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −8 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −7 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −6 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −5 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −4 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −3 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −2 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −1 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| 0 (this device) | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| +1 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| +2 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| +2 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| +3 | K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy (Ireland) | 2016 | — |
| +3 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 15 | 0 |
| 1995 | 12 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 9 | 0 |
| 2001 | 4 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 10 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K090845 | Apex Arc Hip Stem | 2010 |
| * | K111193 | Apex Arc Hip StemSummary page 1…FR § 888.3358, §888.3353, § 888.3390 Product Code LPH, LZO, MEH, KWY Legally Marketed Apex ARC Hip Stem (K09084S), Apex ARC Hip Stem (K111193) Predicate Device(s) Device The Apex ARC Hip Stem consists of a curved, rectangular t… | 2011 |
What descends from it? (52)
See all 522 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 18 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 33 of the 118 ancestors have a recall of any class.
- Of its descendants, K123991 (Depuy France S.A.S., 2013) has gone furthest, with 48 descendants of its own.
- 2 other devices also cite its predicate K090845.
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. 2012, 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 ARC Hip Stem is intended for use as the femoral component of a primary, or revision total hip replacement when used with the Apex Interface Acetabular System. The Apex Interface Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat the following conditions, as…
Read the full statement (203 words)
The Apex ARC Hip Stem is intended for use as the femoral component of a primary, or revision total hip replacement when used with the Apex Interface Acetabular System. The Apex Interface Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for 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.
The Apex Hip System ARC Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
* Femoral neck and trochanteric fractures of the proximal femur;
* Osteonecrosis of the femoral head;
* Revision procedures where other treatments or devices for these indications have failed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113242: Apex Arc Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113242
Report an extraction error
Are you the manufacturer?
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