510(k) · Cleared
ClearedLongevity IT Highly Crosslinked Polyethylene Constrained Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Cleared on Dec 3, 2010 as substantially equivalent to K071718 (Zimmer, Inc., 2007) and 1 other predicate after a 168-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Dec 3, 2010
- Review
- 168 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to P960047 (1997). 12 ancestors in all, the oldest K934765 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
- 3 generations backK021661 Ringloc Constrained LinersBiomet Orthopedics, Inc. · 2002
- 2 generations backK030923 Epsilon Durasul Constrained Acetabular LinerCenterpulse Orthopedics, Inc. · 2003
- 1 generation backK071718 Trilogy Longevity Constrained LinerZimmer, Inc. · 2007 · Recalled
- This deviceK101730 Longevity IT Highly Crosslinked Polyethylene Constrained LinersZimmer, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK200823 Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK250834 Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P960047 | Osteonics Constrained Acetabular Insert | Howmedica Osteonics Corp. | 1997 | — |
| −3 | K021661 | Ringloc Constrained Liners | Biomet Orthopedics, Inc. | 2002 | — |
| −2 | K030923 | Epsilon Durasul Constrained Acetabular Liner | Centerpulse Orthopedics, Inc. | 2003 | — |
| −1 | K071718 | Trilogy Longevity Constrained Liner | Zimmer, Inc. | 2007 | 1 |
| 0 (this device) | K101730 | Longevity IT Highly Crosslinked Polyethylene Constrained Liners | Zimmer, Inc. | 2010 | — |
| +1 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | 2020 | 1 |
| +2 | K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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 KWZ? 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 KWZ device
- #1 K241461 Mpact Constrained Linerscore 15.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K071718 | Trilogy Longevity Constrained LinerSummary page 1…Uncemented, Metal/Polymer Predicate Device: Trilogy®Longevity Constrained Liner, manufactured by Zimmer, Inc., K071718, cleared 13 July 2007 ContinUnmT ~ and Trilogy Integrated… | 2007 |
| * | K091508 | Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemSummary page 1…ContinUnmT ~ and Trilogy Integrated Taper (IT) Acetabular Systems, manufactured by Zimmer, Inc., K091508, cleared I I September 2009 Device Description: The Longeviity Integrated Taper (IT) Constrained… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | 2020 | 1 |
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 13 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K200823 (Zimmer, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K071718.
How does its category compare?
All KWZ devicesKWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KWZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWZ
104in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWZ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWZ
193in 2025
MAUDE reports naming product code KWZ, 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 | 7 | 104 | 0 | 41 |
| 2008 | 1 | — | 0 | 44 |
| 2009 | 1 | — | 0 | 81 |
| 2010 | 1 | — | 8 | 98 |
| 2011 | 1 | — | 0 | 127 |
| 2012 | 1 | — | 1 | 168 |
| 2013 | 0 | — | 0 | 274 |
| 2014 | 0 | — | 0 | 278 |
| 2015 | 0 | — | 0 | 636 |
| 2016 | 1 | — | 0 | 1,180 |
| 2017 | 2 | — | 0 | 477 |
| 2018 | 0 | — | 0 | 283 |
| 2019 | 0 | — | 0 | 532 |
| 2020 | 0 | — | 0 | 288 |
| 2021 | 0 | — | 0 | 216 |
| 2022 | 0 | — | 0 | 158 |
| 2023 | 0 | — | 1 | 164 |
| 2024 | 1 | — | 0 | 145 |
| 2025 | 1 | — | 0 | 193 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Longevity IT Constrained Liner is indicated as a component of a total hip prosthesis in primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101730: Longevity IT Highly Crosslinked Polyethylene Constrained Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101730
Report an extraction error
Are you the manufacturer?
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