510(k) · Cleared
ClearedLongevity IT Highly Crosslinked Polyethyene Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Oct 22, 2012 as substantially equivalent to K091508 (Zimmer, Inc., 2009) and 3 other predicates after a 24-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Oct 22, 2012
- Review
- 24 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K934765 (1994). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK934765 Trilogy Acetabular SystemZimmer, Inc. · 1994 · Recalled
- 5 generations backK021891 Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc. · 2002 · Recalled
- 4 generations backK091508 Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular…Zimmer, Inc. · 2009 · Recalled
- 3 generations backK093846 Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc. · 2010
- 2 generations backK101229 Longevity IT Highly Crosslinked Polyethylene Elevated Liners…Zimmer, Inc. · 2010
- 1 generation backK103662 Continuum and Trilogy Integrated Taper (IT) Acetabular Systems…Zimmer, Inc. · 2011
- This deviceK123019 Longevity IT Highly Crosslinked Polyethyene LinersZimmer, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K934765 | Trilogy Acetabular System | Zimmer, Inc. | 1994 | 16 |
| −5 | K021891 | Zimmer Trabecular Metal Modular Acetabular System | Zimmer, Inc. | 2002 | 3 |
| −4 | K091508 | Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System | Zimmer, Inc. | 2009 | 3 |
| −3 | K093846 | Longevity IT Highly Crosslinked Polyethylene Elevated Liners | Zimmer, Inc. | 2010 | — |
| −2 | K101229 | Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum… | Zimmer, Inc. | 2010 | — |
| −1 | K103662 | Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT… | Zimmer, Inc. | 2011 | — |
| 0 (this device) | K123019 | Longevity IT Highly Crosslinked Polyethyene Liners | Zimmer, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 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 |
|---|---|---|---|
| * | K091508 | Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemSummary page 2…c5( ) September 27, 2012 Predicate Device: Continuum and Trilogy IT Acetabular Systems, manufactured by Zimmer, K091508, cleared September 11, 2009 Longevity IT Highly Crosslinked P… | 2009 |
| * | K093846 | Longevity IT Highly Crosslinked Polyethylene Elevated LinersSummary page 2…Longevity IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimmer, K093846, cleared February 4,. 20 10 Continuum and Trilogy IT Acetabular Systems &… | 2010 |
| * | K101229 | Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular… | 2010 |
| * | K103662 | Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Summary page 2…gevity IT Highly Crosslinked Polyethylene Elevated, Offset, & Oblique Liners, manufactured by Zimmer, K 103662, cleared April 15, 2011 Device Description: The Longevity IT Highly Crosslinked Polyethylene*… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- 5 of the 13 ancestors have a recall of any class.
- 17 other devices also cite its predicate K091508.
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. 2012, 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 system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The system is intended for use either with or without bone cement in total hip arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123019: Longevity IT Highly Crosslinked Polyethyene Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123019
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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