510(k) · Cleared
Recalled · Class II · 2019Monoblock Press-Fit 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 Aug 24, 2006 as substantially equivalent to K001942 (Plus Orthopedics, 2000) and 2 other predicates after a 227-day review. Its family tree reaches back 4 generations to 1994. 7 later devices descend from it. It has been recalled once.
- Decided
- Aug 24, 2006
- Review
- 227 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K932481 (1994). 9 ancestors in all, the oldest K913231 (1991). 7 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 3 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 2 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- 1 generation backK041950 Apex K2 Hip SystemApex Surgical, LLC · 2004 · Recalled
- This deviceK060072 Monoblock Press-Fit Hip StemOmni Life Science, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK110947 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 · 2 generations on · 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K110947Apex K1 Hip StemOmni Life Science, Inc. · 2011 · cites it directly6descendants
- K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · cites it directly2descendants
- K133381Omni Arc Monoblock Hip StemOmnilife Science · 2014 · 2 generations on2descendants
- K241472Icona Hip StemCorin U.S.A. Limited · 2024 · 2 generations on1descendant
- K261576Icona Hip StemCorin, Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −3 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −2 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| −1 | K041950 | Apex K2 Hip System | Apex Surgical, LLC | 2004 | 1 |
| 0 (this device) | K060072 | Monoblock Press-Fit Hip Stem | Omni Life Science, Inc. | 2006 | — |
| +1 | 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 | — |
| +2 | 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 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (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…K060072 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 K2TM Hip System (K041950). The table below compares the features and characteristics of the Apex K1 Hi… | 2000 |
| * | K021178 | SL-Plus Lateralized StemSummary page 2…K060072 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 K2TM Hip System (K041950). The table below compares the features and characteristics of the Apex K1 Hip Stem to th… | 2002 |
| * | K041950 | Apex K2 Hip SystemSummary page 2…omparison Substantial equivalence is claimed to the SL-Plus® and SLR-Plus® hip stems distributed by Plus Orthopedics (K001942 and K021178), and the Apex K2TM Hip System (K041950). The table below compares the features and characteristics of the Apex K1 Hip Stem to these predicate devices:… | 2004 |
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2019 | Class II | Z-0169-2020 | Under Investigation by firm | Stems missing porous coating on the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K110947 (Omni Life Science, Inc., 2011) has gone furthest, with 6 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 Ki 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/K060072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060072: Monoblock Press-Fit 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/K060072
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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