510(k) · Cleared
ClearedApex Modular HA Hip Stem
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 Feb 10, 2005 as substantially equivalent to K021403 (Biomet Orthopedics, Inc., 2002) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1991. 131 later devices descend from it.
- Decided
- Feb 10, 2005
- Review
- 90 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K913231 (1991). 9 ancestors in all. 131 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK913231 S-Rom (TM) Total Lhip System W/Ceramic HeadJoint Medical Products Corp. · 1991
- 1 generation backK000788 Apex Modular Hip StemApex Surgical, LLC · 2000
- This deviceK043123 Apex Modular HA Hip StemApex Surgical, LLC · 2005
- Descendant · cites it directly · 68 of its ownK071916 Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · Recalled
- Descendant · cites it directly · 61 of its ownK080842 Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008
- Descendant · 2 generations on · 60 of its ownK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- Descendant · 2 generations on · 59 of its ownK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- Descendant · 2 generations on · 58 of its ownK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
Showing 5 of 131 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 131 · See all- K071916Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · cites it directly68descendants
- K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008 · cites it directly61descendants
- K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013 · 2 generations on60descendants
- K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009 · 2 generations on59descendants
- K090845Apex Arc Hip StemOmni Life Science, Inc. · 2010 · 2 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913231 | S-Rom (TM) Total Lhip System W/Ceramic Head | Joint Medical Products Corp. | 1991 | — |
| −1 | K000788 | Apex Modular Hip Stem | Apex Surgical, LLC | 2000 | — |
| 0 (this device) | K043123 | Apex Modular HA Hip Stem | Apex Surgical, LLC | 2005 | — |
| +1 | K071916 | Metha Hip System | Aesculap Implant Systems, Inc. | 2008 | 1 |
| +1 | K080842 | Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes] | Omni Life Science, Inc. | 2008 | — |
| +2 | K131353 | Comprehensive Reverse Shoulder - Titanium Glenosphere | Biomet Manufacturing Corp | 2013 | — |
| +2 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| +2 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 9 | 0 |
| 2022 | 12 | 0 |
| 2023 | 14 | 0 |
| 2024 | 14 | 0 |
| 2025 | 19 | 0 |
| 2026 | 20 | 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 |
|---|---|---|---|
| * | K021403 | HA Mallory/Head Porous Femoral Stem & HA Mallory/Head Porous Lateralized Femoral StemSummary page 2…from wrought cobalt chromium alloy. 5. Predicate Device Comparison Substantial equivalence is claimed to the HA Mallory/Head® Porous Femoral Stem distributed by Biomet (K021403) and the Apex Modular TM Hip System (K000788). The table below compares the features and characteristics of the Apex ModularTM HA… | 2002 |
| * | K000788 | Apex Modular Hip StemSummary page 2…ate Device Comparison Substantial equivalence is claimed to the HA Mallory/Head® Porous Femoral Stem distributed by Biomet (K021403) and the Apex Modular TM Hip System (K000788). The table below compares the features and characteristics of the Apex ModularTM HA Hip Stem to these predicate devices:… | 2000 |
| † | K041950 | Apex K2 Hip System | 2004 |
What descends from it? (131)
See all 1313 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 14 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K071916 (Aesculap Implant Systems, Inc., 2008) has gone furthest, with 68 descendants of its own.
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 ModularTM HA Hip Stem is intended for use as the femoral component of a primary or revision 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/K043123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043123: Apex Modular HA 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/K043123
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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