510(k) · Cleared
Recalled · Class II · 2017Delta TT Acetabular System
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 Jun 30, 2014 as substantially equivalent to K112898 (Lima Corporate S.P.A., 2012) and 1 other predicate after a 33-day review. Its family tree reaches back 9 generations to 1994. 10 later devices descend from it. It has been recalled once.
- Decided
- Jun 30, 2014
- Review
- 33 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K931641 (1994). 78 ancestors in all, the oldest K810258 (1981). 10 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations between
- 3 generations backK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
- 2 generations backK102975 Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010
- 1 generation backK112898 Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012
- This deviceK141395 Delta TT Acetabular SystemLima Corporate S.P.A. · 2014
- Descendant · cites it directly · 3 of its ownK182099 Delta TT ProLima Corporate S.P.A. · 2018
- Descendant · 2 generations on · 2 of its ownK191622 Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A. · 2019
- Descendant · cites it directly · 2 of its ownK150855 H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015
- Descendant · cites it directly · 1 of its ownK172456 Bone Screws 6.5mmLima Corporate S.P.A. · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK160011 H-Max S stemLima Corporate S.P.A. · 2016
Show all 9 generations
- Root · 9 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 8 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 7 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 6 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 5 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 4 generations backK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
- 3 generations backK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
- 2 generations backK102975 Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010
- 1 generation backK112898 Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012
- This deviceK141395 Delta TT Acetabular SystemLima Corporate S.P.A. · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K182099Delta TT ProLima Corporate S.P.A. · 2018 · cites it directly3descendants
- K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A. · 2019 · 2 generations on2descendants
- K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015 · cites it directly2descendants
- K172456Bone Screws 6.5mmLima Corporate S.P.A. · 2018 · cites it directly1descendant
- K160011H-Max S stemLima Corporate S.P.A. · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −8 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −7 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −6 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −5 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −4 | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | Exactech, Inc. | 2005 | 12 |
| −3 | K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | 2007 | 16 |
| −2 | K102975 | Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole | Exactech, Inc. | 2010 | — |
| −1 | K112898 | Delta TT Cups, Delta TT Liners, Bone Screws | Lima Corporate S.P.A. | 2012 | — |
| 0 (this device) | K141395 | Delta TT Acetabular System | Lima Corporate S.P.A. | 2014 | — |
| +1 | K182099 | Delta TT Pro | Lima Corporate S.P.A. | 2018 | — |
| +2 | K191622 | Delta Multihole TT Pro Acetabular System | Lima Corporate S.P.A. | 2019 | — |
| +1 | K150855 | H-MAX S Femoral Hip System | Lima Corporate S.P.A. | 2015 | — |
| +1 | K172456 | Bone Screws 6.5mm | Lima Corporate S.P.A. | 2018 | 2 |
| +2 | K160011 | H-Max S stem | Lima Corporate S.P.A. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 11 | 0 |
| 1995 | 7 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 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 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 |
|---|---|---|---|
| * | K112898 | Delta TT Cups, Delta TT Liners, Bone Screws | 2012 |
| * | K091508 | Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemSummary page 2…Delta TT cup is intended for cementless use. Predicate Devices: * Delta TT Acetabular System (Limacorporate, Kl 12898) * Continuum Acetabular System (Zimmer, K09 1508) Comparable Features to Predicate Device(s): The new sizes of the Delta TT Acetabular Cups are identical to the intended use and… | 2009 |
What descends from it? (10)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 8, 2017 | Class II | Z-0068-2018 | Vendor change control | An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 20 of the 78 ancestors have a recall of any class.
- Of its descendants, K182099 (Lima Corporate S.P.A., 2018) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K112898.
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. 2014, 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 Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
* Rheumatoid arthritis;
* Post-traumatic arthritis,
* Correction of functional deformity;
* Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
* Revisions in cases of good remaining bone stock.
The Delta TT cup is intended for cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141395: Delta TT Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141395
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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