510(k) · Cleared
Recalled · Class II · 2021Apex K2 Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex Surgical, LLC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Dec 21, 2004 as substantially equivalent to K001942 (Plus Orthopedics, 2000) and 2 other predicates after a 154-day review. Its family tree reaches back 3 generations to 1994. 62 later devices descend from it. It has been recalled once.
- Decided
- Dec 21, 2004
- Review
- 154 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K932481 (1994). 8 ancestors in all, the oldest K913231 (1991). 62 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 2 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 1 generation backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- This deviceK041950 Apex K2 Hip SystemApex Surgical, LLC · 2004
- Descendant · cites it directly · 58 of its ownK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 53 of its ownK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- Descendant · 2 generations on · 52 of its ownK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- Descendant · 3 generations on · 48 of its ownK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- Descendant · 4 generations on · 38 of its ownK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K090845Apex Arc Hip StemOmni Life Science, Inc. · 2010 · cites it directly58descendants
- K111193Apex Arc Hip StemOmni Life Science, Inc. · 2011 · 2 generations on53descendants
- K113242Apex Arc Hip StemOmni Life Science, Inc. · 2012 · 2 generations on52descendants
- K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · 3 generations on48descendants
- K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · 4 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −2 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −1 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| 0 (this device) | K041950 | Apex K2 Hip System | Apex Surgical, LLC | 2004 | — |
| +1 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| +2 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| +2 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| +3 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| +4 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 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? (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 |
|---|---|---|---|
| * | K001942 | SL-Plus and SLR-Plus StemsSummary page 2…ought cobalt chromium alloy. 5. Predicate Device Comparison Substantial equivalence is claimed to the SL-Plus® and SLR-Plus® hip stems distributed by Plus Orthopedics (K001942 and K021178), and the Apex Modular TM Hip System (K000788). The table below compares the features and characteristics of the Apex… | 2000 |
| * | K021178 | SL-Plus Lateralized StemSummary page 2…chromium alloy. 5. Predicate Device Comparison Substantial equivalence is claimed to the SL-Plus® and SLR-Plus® hip stems distributed by Plus Orthopedics (K001942 and K021178), and the Apex Modular TM Hip System (K000788). The table below compares the features and characteristics of the Apex ModularfM H… | 2002 |
| * | K000788 | Apex Modular Hip StemSummary page 2…on Substantial equivalence is claimed to the SL-Plus® and SLR-Plus® hip stems distributed by Plus Orthopedics (K001942 and K021178), and the Apex Modular TM Hip System (K000788). The table below compares the features and characteristics of the Apex ModularfM Hip Stem to these predicate devices:… | 2000 |
What descends from it? (62)
See all 623 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 1, 2021 | Class II | Z-0237-2022 | Process control | The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K090845 (Omni Life Science, Inc., 2010) has gone furthest, with 58 descendants of its own.
- 8 other devices also cite its predicate K001942.
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.
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 K2TM Hip Stem is intended for use as the femoral component of a
primary total hip replacement. This femoral hip stem is intended for uncemented
fixation and single use implantation. This prosthesis 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/K041950 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041950: Apex K2 Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041950
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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