510(k) · Cleared
ClearedThe Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implex Corp. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Aug 7, 2000 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 81 later devices descend from it.
- Decided
- Aug 7, 2000
- Review
- 88 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 0
81 later devices descend from it, 2 citing it directly.
- This deviceK001471 The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZImplex Corp. · 2000
- Descendant · cites it directly · 79 of its ownK061067 Trabecular Metal Acetabular AugmentsZimmer Trabecular · 2006 · Recalled
- Descendant · cites it directly · 54 of its ownK052888 Porous Titanium Acetabular AugmentsBiomet Manufacturing Corp · 2005
- Descendant · 2 generations on · 53 of its ownK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
- Descendant · 3 generations on · 40 of its ownK143393 Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · Recalled
- Descendant · 4 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 81 · See all- K061067Trabecular Metal Acetabular AugmentsZimmer Trabecular · 2006 · cites it directly79descendants
- K052888Porous Titanium Acetabular AugmentsBiomet Manufacturing Corp · 2005 · cites it directly54descendants
- K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010 · 2 generations on53descendants
- K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · 3 generations on40descendants
- K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001471 | The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZ | Implex Corp. | 2000 | — |
| +1 | K061067 | Trabecular Metal Acetabular Augments | Zimmer Trabecular | 2006 | 4 |
| +1 | K052888 | Porous Titanium Acetabular Augments | Biomet Manufacturing Corp | 2005 | — |
| +2 | K100391 | Depuy Universal Gription TF Cones | DePuy Orthopaedics, Inc. | 2010 | — |
| +3 | K143393 | Triathlon Tritanium Cone Augments | Stryker Orthopaedics | 2015 | 1 |
| +4 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 10 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 11 | 0 |
| 2025 | 18 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (81)
See all 812 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?
- Of its descendants, K061067 (Zimmer Trabecular, 2006) has gone furthest, with 79 descendants of its own.
How does its category compare?
All LWJ devicesLWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWJ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LWJ
Too few LWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWJ
51in 2025
MAUDE reports naming product code LWJ, 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 | 2 | — | 10 | 68 |
| 2008 | 1 | — | 2 | 72 |
| 2009 | 1 | — | 2 | 84 |
| 2010 | 0 | — | 0 | 132 |
| 2011 | 1 | — | 0 | 255 |
| 2012 | 1 | — | 0 | 390 |
| 2013 | 0 | — | 1 | 522 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 310 |
| 2016 | 0 | — | 0 | 293 |
| 2017 | 0 | — | 0 | 311 |
| 2018 | 0 | — | 0 | 227 |
| 2019 | 0 | — | 0 | 210 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 155 |
| 2022 | 0 | — | 0 | 91 |
| 2023 | 0 | — | 2 | 72 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K001471 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001471: The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001471
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026