510(k) · Cleared
ClearedApex K1 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 Jun 16, 2011 as substantially equivalent to K060072 (Omni Life Science, Inc., 2006) after a 73-day review. Its family tree reaches back 5 generations to 1994. 6 later devices descend from it.
- Decided
- Jun 16, 2011
- Review
- 73 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K932481 (1994). 10 ancestors in all, the oldest K913231 (1991). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 4 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 3 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- 2 generations backK041950 Apex K2 Hip SystemApex Surgical, LLC · 2004 · Recalled
- 1 generation backK060072 Monoblock Press-Fit Hip StemOmni Life Science, Inc. · 2006 · Recalled
- This deviceK110947 Apex K1 Hip StemOmni Life Science, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK133381 Omni Arc Monoblock Hip StemOmnilife Science · 2014
- Descendant · 2 generations on · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
- Descendant · 3 generations on · 0 of its ownK261576 Icona Hip StemCorin, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK172467 OMNI ARC Anteverted Neck Hip StemOmnilife Science · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · cites it directly2descendants
- K133381Omni Arc Monoblock Hip StemOmnilife Science · 2014 · cites it directly2descendants
- K241472Icona Hip StemCorin U.S.A. Limited · 2024 · 2 generations on1descendant
- K261576Icona Hip StemCorin, Ltd. · 2026 · 3 generations on0descendants
- K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −4 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −3 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| −2 | K041950 | Apex K2 Hip System | Apex Surgical, LLC | 2004 | 1 |
| −1 | K060072 | Monoblock Press-Fit Hip Stem | Omni Life Science, Inc. | 2006 | 1 |
| 0 (this device) | K110947 | Apex K1 Hip Stem | Omni Life Science, Inc. | 2011 | — |
| +1 | K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular… | Corin, Ltd. | 2021 | — |
| +1 | K133381 | Omni Arc Monoblock Hip Stem | Omnilife Science | 2014 | — |
| +2 | K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024 | — |
| +3 | K261576 | Icona Hip Stem | Corin, Ltd. | 2026 | — |
| +2 | K172467 | OMNI ARC Anteverted Neck Hip Stem | Omnilife Science | 2017 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K060072 | Monoblock Press-Fit Hip StemSummary page 1…Regulatory Class Class 11per 21 CFR §888.3358, §888.3353, §888.3390 Product Code [PH, LZO,KWY Legally Marketed K060072- Apex K1T" Hip Stem Predicate Device(s) Device Description The Apex K1'" Hip Stems are rectangular in… | 2006 |
What descends from it? (6)
2 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 17 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K201657 (Corin, Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K060072.
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. 2011, 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 K1T" 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 prosthesis may be used for hip arthroplasty to treat the following…
Read the full statement (199 words)
The Apex Hip System K1T" 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 prosthesis 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 K1 Femoral Stem is also intended for use in hemniarthroplasty 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 hemniarthroplasty 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/K110947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110947: Apex K1 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/K110947
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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