510(k) · Cleared
ClearedContinuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly Crosslinked Polyethylene Elevated LI
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 Apr 15, 2011 as substantially equivalent to K091508 (Zimmer, Inc., 2009) and 2 other predicates after a 121-day review. Its family tree reaches back 5 generations to 1994. 137 later devices descend from it.
- Decided
- Apr 15, 2011
- Review
- 121 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K934765 (1994). 12 ancestors in all. 137 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK934765 Trilogy Acetabular SystemZimmer, Inc. · 1994 · Recalled
- 4 generations backK021891 Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc. · 2002 · Recalled
- 3 generations backK091508 Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular…Zimmer, Inc. · 2009 · Recalled
- 2 generations backK093846 Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc. · 2010
- 1 generation backK101229 Longevity IT Highly Crosslinked Polyethylene Elevated Liners…Zimmer, Inc. · 2010
- This deviceK103662 Continuum and Trilogy Integrated Taper (IT) Acetabular Systems…Zimmer, Inc. · 2011
- Descendant · cites it directly · 88 of its ownK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- Descendant · 2 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · cites it directly · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- Descendant · 2 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- Descendant · 3 generations on · 17 of its ownK150090 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015
Showing 5 of 137 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 137 · See all- K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012 · cites it directly88descendants
- K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 2 generations on59descendants
- K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · cites it directly53descendants
- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 2 generations on35descendants
- K150090Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K934765 | Trilogy Acetabular System | Zimmer, Inc. | 1994 | 16 |
| −4 | K021891 | Zimmer Trabecular Metal Modular Acetabular System | Zimmer, Inc. | 2002 | 3 |
| −3 | K091508 | Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System | Zimmer, Inc. | 2009 | 3 |
| −2 | K093846 | Longevity IT Highly Crosslinked Polyethylene Elevated Liners | Zimmer, Inc. | 2010 | — |
| −1 | K101229 | Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum… | Zimmer, Inc. | 2010 | — |
| 0 (this device) | K103662 | Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT… | Zimmer, Inc. | 2011 | — |
| +1 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| +2 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| +1 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| +2 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| +3 | K150090 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2015 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 8 | 0 |
| 2019 | 17 | 0 |
| 2020 | 10 | 0 |
| 2021 | 8 | 0 |
| 2022 | 12 | 0 |
| 2023 | 10 | 0 |
| 2024 | 15 | 0 |
| 2025 | 16 | 0 |
| 2026 | 19 | 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 |
|---|---|---|---|
| * | K091508 | Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemSummary page 1…21 CFR § 888.3353 Predicate Device: Continuum®and Trilogy® IT Acetabular Systems, manufactured by Zimmer, K09 1508, cleared I11 September 2009 P4. ===… | 2009 |
| * | K101229 | Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular…Summary page 2…Longevity IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimmer, K101229, cleared 03 December 2010 Trilogy®Acetabular System Longevity® Liners,… | 2010 |
| * | K990135 | Trilogy Acetabular System Longevity Crosslinked PolyethyleneSummary page 2…01229, cleared 03 December 2010 Trilogy®Acetabular System Longevity® Liners, manufactured by Zimmer, K990 135, cleared 12 July 1999 Device Description: The proposed Continuum and Trilogy IT… | 1999 |
What descends from it? (137)
See all 1376 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | 2012 | 88 |
| K121874 | G7 Acetabular System | 2012 | 53 |
| K122185 | U-Motion II Acetabular System | 2013 | 7 |
| K151448 | Continuum and Trilogy Integrated Taper (IT) Acetabular Systems | 2015 | 6 |
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | 2020 | 1 |
| K123019 | Longevity IT Highly Crosslinked Polyethyene Liners | 2012 | 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?
- The line of descent spans 17 years and passes through 1 company; a new generation was cleared every 10 months on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K120370 (Zimmer, Inc., 2012) has gone furthest, with 88 descendants of its own.
- 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. 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 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/K103662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103662: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly Crosslinked Polyethylene Elevated LI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103662
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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