510(k) · Cleared
ClearedArTT Augments and Buttresses and Bone Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Aug 29, 2025 as substantially equivalent to K061067 (Zimmer Trabecular, 2006) and 1 other predicate after an 86-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Aug 29, 2025
- Review
- 86 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K982302 (1998). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 5 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
- 4 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
- 3 generations backK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
- 2 generations backK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
- 1 generation backK123924 Depuy Gription TF 5.5MM Sterile Locking ScrewsDepuy Orthopaedics · 2013
- This deviceK251718 ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K982302 | Implex Continuum Knee - Hedrocel Tibial Spacers | Implex Corp. | 1998 | — |
| −5 | K024161 | Nexgen Complete Knee Solution - Trabecular Metal Augments | Implex Corp. | 2003 | 2 |
| −4 | K040487 | Trabecular Metal Knee System Augments | Implex Corp. | 2004 | 1 |
| −3 | K053340 | Trabecular Metal Tibial and Femoral Cone Augments | Zimmer Trabecular | 2006 | — |
| −2 | K100391 | Depuy Universal Gription TF Cones | DePuy Orthopaedics, Inc. | 2010 | — |
| −1 | K123924 | Depuy Gription TF 5.5MM Sterile Locking Screws | Depuy Orthopaedics | 2013 | — |
| 0 (this device) | K251718 | ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.P.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K061067 | Trabecular Metal Acetabular AugmentsSummary page 5…Company Device name Cleared via 1 (Primary predicate) Zimmer Trabecular Metal Trabecular Metal Acetabular K061067 Technology, Inc. (Z-TMT) Augments 2 (Additional predicate) DePuy Orthopaedics, Inc. DePuy Grip… | 2006 |
| * | K123924 | Depuy Gription TF 5.5MM Sterile Locking ScrewsSummary page 5…K061067 Technology, Inc. (Z-TMT) Augments 2 (Additional predicate) DePuy Orthopaedics, Inc. DePuy Gription TF 5.5mm Sterile K123924 Locking Screws LimaCorporate, Traditional 510(k)… | 2013 |
| † | K190057 | DJO Acetabular System | 2019 |
| † | K210717 | Bone Screws dia. 5,0 mm | 2021 |
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 27 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 5 of the 15 ancestors have a recall of any class.
- 4 other devices also cite its predicate K061067.
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. 2025, 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?
ArTT Augments and Buttresses are indicated to be used, in combination with EMPOWR Acetabular Cup System, as an alternative to structural allograft in skeletally mature patients in cases of segmental acetabular deficiencies.
ArTT Augments and Buttresses are indicated for cementless use to the bone interface; and are affixed to the mating acetabular cup using bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251718: ArTT Augments and Buttresses and Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251718
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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