510(k) · Cleared
ClearedApex Modular 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 Aug 4, 2000 as substantially equivalent to K913231 (Joint Medical Products Corp., 1991) and 3 other predicates after a 147-day review. Its family tree reaches back 1 generation to 1991. 168 later devices descend from it.
- Decided
- Aug 4, 2000
- Review
- 147 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K913231 (1991). 4 ancestors in all. 168 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK913231 S-Rom (TM) Total Lhip System W/Ceramic HeadJoint Medical Products Corp. · 1991
- This deviceK000788 Apex Modular Hip StemApex Surgical, LLC · 2000
- Descendant · cites it directly · 131 of its ownK043123 Apex Modular HA Hip StemApex Surgical, LLC · 2005
- Descendant · 2 generations on · 68 of its ownK071916 Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · Recalled
- Descendant · cites it directly · 62 of its ownK041950 Apex K2 Hip SystemApex Surgical, LLC · 2004 · Recalled
- Descendant · 2 generations on · 61 of its ownK080842 Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008
- Descendant · 3 generations on · 60 of its ownK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
Showing 5 of 168 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 168 · See all- K043123Apex Modular HA Hip StemApex Surgical, LLC · 2005 · cites it directly131descendants
- K071916Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · 2 generations on68descendants
- K041950Apex K2 Hip SystemApex Surgical, LLC · 2004 · cites it directly62descendants
- K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008 · 2 generations on61descendants
- K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013 · 3 generations on60descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913231 | S-Rom (TM) Total Lhip System W/Ceramic Head | Joint Medical Products Corp. | 1991 | — |
| 0 (this device) | K000788 | Apex Modular Hip Stem | Apex Surgical, LLC | 2000 | — |
| +1 | K043123 | Apex Modular HA Hip Stem | Apex Surgical, LLC | 2005 | — |
| +2 | K071916 | Metha Hip System | Aesculap Implant Systems, Inc. | 2008 | 1 |
| +1 | K041950 | Apex K2 Hip System | Apex Surgical, LLC | 2004 | 1 |
| +2 | K080842 | Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes] | Omni Life Science, Inc. | 2008 | — |
| +3 | K131353 | Comprehensive Reverse Shoulder - Titanium Glenosphere | Biomet Manufacturing Corp | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 12 | 0 |
| 2022 | 14 | 0 |
| 2023 | 16 | 0 |
| 2024 | 14 | 0 |
| 2025 | 24 | 0 |
| 2026 | 22 | 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 |
|---|---|---|---|
| * | K913231 | S-Rom (TM) Total Lhip System W/Ceramic HeadSummary page 2…Apex Modular S-ROM@ Biomet Modular Hip Stem FemoralStem Hip System (K913231,K934412,(K921274) andK954935) Witt TENN… | 1991 |
| * | K934412 | Coated ZT Proximal SleeveSummary page 2…Apex Modular S-ROM@ Biomet Modular Hip Stem FemoralStem Hip System (K913231,K934412,(K921274) andK954935) Witt TENN… | 1994 |
| * | K954935 | S-Rom Femoral Hip Stem - Size 14 X 8Summary page 2…Hip Stem FemoralStem Hip System (K913231,K934412,(K921274) andK954935) Witt TENN !Z"A.TX'… | 1996 |
| * | K921274 | Metallic Toatal Hip SystemSummary page 2…lar S-ROM@ Biomet Modular Hip Stem FemoralStem Hip System (K913231,K934412,(K921274) andK954935) Witt TENN… | 1994 |
What descends from it? (168)
See all 1688 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043123 | Apex Modular HA Hip Stem | 2005 | 131 |
| K041950 | Apex K2 Hip System | 2004 | 62 |
| K100555 | Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK | 2010 | 34 |
| K101575 | Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810… | 2010 | 24 |
| K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell… | 2021 | 2 |
| K241472 | Icona Hip Stem | 2024 | 1 |
| K041850 | Medallion Modular Hip System | 2004 | 1 |
| 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?
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 Modula(m 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K000788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000788: Apex Modular 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/K000788
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026