510(k) Report

510(k) · Cleared

Cleared

Delta TT Cups, Delta TT Liners, Bone Screws

K112898510(k) TraditionalCleared Dec 21, 2012445-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lima Corporate S.P.A. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Dec 21, 2012 as substantially equivalent to K091508 (Zimmer, Inc., 2009) and 14 other predicates after a 445-day review. Its family tree reaches back 8 generations to 1994. 12 later devices descend from it.

Decided
Dec 21, 2012
Review
445 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
15

Its longest line of descent runs back 8 generations to K931641 (1994). 77 ancestors in all, the oldest K810258 (1981). 12 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2007: 2 other ancestors2005: 2 other ancestors2002: 2 other ancestors2000: 8 other ancestors1998: 6 other ancestors1996: 6 other ancestors1995: 7 other ancestors1994: 11 other ancestors1985: 3 other ancestors2003: 2 other ancestors2001: 2 other ancestors1997: 2 other ancestors1999: 5 other ancestors1993: 4 other ancestors1992: 2 other ancestors2004: 1 other ancestor1981: 1 other ancestor1986: 2 other ancestors2018: 2 descendants cleared2019: 3 descendants cleared2015: 1 descendant cleared2025: 2 descendants cleared2014: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant clearedK931641 · Porocoat Porous Coating · Depuy, Inc. · 1994K003800 · Aml Hip Prosthesis · DePuy Orthopaedics, Inc. · 2001K012364 · Aml Hip Prosthesis · DePuy Orthopaedics, Inc. · 2001K030236 · Acumatch P-Series Porous Press-Fit Femoral Component · Exactech, Inc. · 2003K041906 · Exactech 12/14 Total Hip System · Exactech, Inc. · 2004 · recalledK051556 · Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene · Exactech, Inc. · 2005 · recalledK070479 · Exactech Novation Crown Cup and Liners · Exactech, Inc. · 2007 · recalledK102975 · Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole · Exactech, Inc. · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 14 other ancestors2 generations back: 9 other ancestors3 generations back: 13 other ancestors4 generations back: 17 other ancestors5 generations back: 12 other ancestors6 generations back: 3 other ancestors7 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 5 descendants3 generations forward: 1 descendant K102975 · Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole · Exactech, Inc. · 2010K070479 · Exactech Novation Crown Cup and Liners · Exactech, Inc. · 2007 · recalledK051556 · Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene · Exactech, Inc. · 2005 · recalledK041906 · Exactech 12/14 Total Hip System · Exactech, Inc. · 2004 · recalledK030236 · Acumatch P-Series Porous Press-Fit Femoral Component · Exactech, Inc. · 2003K012364 · Aml Hip Prosthesis · DePuy Orthopaedics, Inc. · 2001K003800 · Aml Hip Prosthesis · DePuy Orthopaedics, Inc. · 2001K931641 · Porocoat Porous Coating · Depuy, Inc. · 1994−50
  1. Root · 8 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 7 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
  3. 6 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
  4. 5 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
  5. 4 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
  6. 3 generations backK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
  7. 2 generations backK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
  8. 1 generation backK102975 Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010
  9. This deviceK112898 Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012
  10. Descendant · cites it directly · 10 of its ownK141395 Delta TT Acetabular SystemLima Corporate S.P.A. · 2014 · Recalled
  11. Descendant · cites it directly · 3 of its ownK182099 Delta TT ProLima Corporate S.P.A. · 2018
  12. Descendant · 2 generations on · 2 of its ownK191622 Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A. · 2019
  13. Descendant · cites it directly · 2 of its ownK150855 H-MAX S Femoral Hip SystemLima Corporate S.P.A. · 2015
  14. Descendant · cites it directly · 1 of its ownK172456 Bone Screws 6.5mmLima Corporate S.P.A. · 2018 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12016: 12017: 12018: 22019: 32020: 12025: 2
2014high 3 (2019) · low 0 (2021)2026

Most influential descendants

Showing 5 of 12 · See all
  • K141395Delta TT Acetabular SystemLima Corporate S.P.A. · 2014 · cites it directly10descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K931641Porocoat Porous CoatingDepuy, Inc.1994—
−7K003800Aml Hip ProsthesisDePuy Orthopaedics, Inc.2001—
−6K012364Aml Hip ProsthesisDePuy Orthopaedics, Inc.2001—
−5K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc.2003—
−4K041906Exactech 12/14 Total Hip SystemExactech, Inc.20041
−3K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc.200512
−2K070479Exactech Novation Crown Cup and LinersExactech, Inc.200716
−1K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc.2010—
0 (this device)K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.2012—
+1K141395Delta TT Acetabular SystemLima Corporate S.P.A.20141
+1K182099Delta TT ProLima Corporate S.P.A.2018—
+2K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.2019—
+1K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.2015—
+1K172456Bone Screws 6.5mmLima Corporate S.P.A.20182

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198530
198620
199220
199340
1994110
199570
199660
199720
199860
199950
200080
200120
200220
200320
200410
200520
200720
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201610
201710
201820
201930
202010
202520
FIG. 1 — Lineage of K112898, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (15)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K091508Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System
Summary page 2
…good remaining bone stock. The Delta TT cup is intended for cementless use. Predicate Devices: Continuum and Trilogy Integrated taper Acetabular systems (Zimmer Inc., K09 1508); Regenerex RingLoc + Modular acetabular shell and ArComXL polyethylene liners, (Biomet, K070369 / K04205 1); Reflection Dual Dim…
Zimmer, Inc.20093
*K070369Regenerx Ringloc + Modular Acetabular Shells
Summary page 2
…Continuum and Trilogy Integrated taper Acetabular systems (Zimmer Inc., K09 1508); Regenerex RingLoc + Modular acetabular shell and ArComXL polyethylene liners, (Biomet, K070369 / K04205 1); Reflection Dual Dimension shell (Smith & Nephew, K960094); Pinnacle Acetabular System (DePuy, KOO01534); Exactech® N…
Biomet, Inc.200719
*K042051Arcomxl Polyethylene Liners
Summary page 2
…and Trilogy Integrated taper Acetabular systems (Zimmer Inc., K09 1508); Regenerex RingLoc + Modular acetabular shell and ArComXL polyethylene liners, (Biomet, K070369 / K04205 1); Reflection Dual Dimension shell (Smith & Nephew, K960094); Pinnacle Acetabular System (DePuy, KOO01534); Exactech® Novation®D C…
Biomet, Inc.20051
*K960094Reflection Dual Dimension Shell
Summary page 2
…, K09 1508); Regenerex RingLoc + Modular acetabular shell and ArComXL polyethylene liners, (Biomet, K070369 / K04205 1); Reflection Dual Dimension shell (Smith & Nephew, K960094); Pinnacle Acetabular System (DePuy, KOO01534); Exactech® Novation®D Crown Cup® with Inte~rip TM Acetabular Shell (Exactech, Inc.…
Smith & Nephew Richards, Inc.19961
*K001534Pinnacle Acetabular SystemDePuy Orthopaedics, Inc.2000—
*K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole
Summary page 2
…imension shell (Smith & Nephew, K960094); Pinnacle Acetabular System (DePuy, KOO01534); Exactech® Novation®D Crown Cup® with Inte~rip TM Acetabular Shell (Exactech, Inc. K102975); EMP Cups (Encore Orthopedics Inc, K9731 19, K974093, K974095, K072154); CLS Spotorno Expansion Cup / Threaded Acetabular Cup (Z…
Exactech, Inc.2010—
*K973119Foundation Porous Acetabular System
Summary page 2
…nnacle Acetabular System (DePuy, KOO01534); Exactech® Novation®D Crown Cup® with Inte~rip TM Acetabular Shell (Exactech, Inc. K102975); EMP Cups (Encore Orthopedics Inc, K9731 19, K974093, K974095, K072154); CLS Spotorno Expansion Cup / Threaded Acetabular Cup (Zimmer Inc., K850766); Zimmer Trabecular Metal…
Encore Orthopedics, Inc.1998—
*K974093Foundation Porous Coated Hemispherical Shell
Summary page 2
…tabular System (DePuy, KOO01534); Exactech® Novation®D Crown Cup® with Inte~rip TM Acetabular Shell (Exactech, Inc. K102975); EMP Cups (Encore Orthopedics Inc, K9731 19, K974093, K974095, K072154); CLS Spotorno Expansion Cup / Threaded Acetabular Cup (Zimmer Inc., K850766); Zimmer Trabecular Metal Modular…
Encore Orthopedics, Inc.1998—
*K974095Foundation Porous Coated Flared Rim Shell
Summary page 2
…ystem (DePuy, KOO01534); Exactech® Novation®D Crown Cup® with Inte~rip TM Acetabular Shell (Exactech, Inc. K102975); EMP Cups (Encore Orthopedics Inc, K9731 19, K974093, K974095, K072154); CLS Spotorno Expansion Cup / Threaded Acetabular Cup (Zimmer Inc., K850766); Zimmer Trabecular Metal Modular Acetabula…
Encore Orthopedics, Inc.1998—
*K072154Foundation (FMP) Porous Coated Spiked Acetabular System
Summary page 2
…Puy, KOO01534); Exactech® Novation®D Crown Cup® with Inte~rip TM Acetabular Shell (Exactech, Inc. K102975); EMP Cups (Encore Orthopedics Inc, K9731 19, K974093, K974095, K072154); CLS Spotorno Expansion Cup / Threaded Acetabular Cup (Zimmer Inc., K850766); Zimmer Trabecular Metal Modular Acetabular System…
Encore Medical L.P.20071
*K850766Zimmer Threaded Acetabular Cup
Summary page 2
…hell (Exactech, Inc. K102975); EMP Cups (Encore Orthopedics Inc, K9731 19, K974093, K974095, K072154); CLS Spotorno Expansion Cup / Threaded Acetabular Cup (Zimmer Inc., K850766); Zimmer Trabecular Metal Modular Acetabular System (Zimmer Inc., K021891); Trilogy Acetabular System (Zimmer Inc., K953490, K934…
Zimmer, Inc.1985—
*K021891Zimmer Trabecular Metal Modular Acetabular System
Summary page 2
…K974093, K974095, K072154); CLS Spotorno Expansion Cup / Threaded Acetabular Cup (Zimmer Inc., K850766); Zimmer Trabecular Metal Modular Acetabular System (Zimmer Inc., K021891); Trilogy Acetabular System (Zimmer Inc., K953490, K934765); Alloclassic Zwcymuller Cup (Allo Pro Corp., K851213). Comparable Fea…
Zimmer, Inc.20023
*K953490Trilogy Acetabular Shell & Liners 36MM
Summary page 2
…n Cup / Threaded Acetabular Cup (Zimmer Inc., K850766); Zimmer Trabecular Metal Modular Acetabular System (Zimmer Inc., K021891); Trilogy Acetabular System (Zimmer Inc., K953490, K934765); Alloclassic Zwcymuller Cup (Allo Pro Corp., K851213). Comparable Features to Predicate Device(s): the Delta IT Acetabu…
Zimmer, Inc.19952
*K934765Trilogy Acetabular System
Summary page 2
…hreaded Acetabular Cup (Zimmer Inc., K850766); Zimmer Trabecular Metal Modular Acetabular System (Zimmer Inc., K021891); Trilogy Acetabular System (Zimmer Inc., K953490, K934765); Alloclassic Zwcymuller Cup (Allo Pro Corp., K851213). Comparable Features to Predicate Device(s): the Delta IT Acetabular syste…
Zimmer, Inc.199416
*K851213Zweymuller Cup
Summary page 2
…Trabecular Metal Modular Acetabular System (Zimmer Inc., K021891); Trilogy Acetabular System (Zimmer Inc., K953490, K934765); Alloclassic Zwcymuller Cup (Allo Pro Corp., K851213). Comparable Features to Predicate Device(s): the Delta IT Acetabular system is similar to the predicate devices in terms of inte…
Allo Pro Corp.1985—

Also cleared against K091508: 17 other devices →

What descends from it? (12)

See all 12

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141395Delta TT Acetabular SystemLima Corporate S.P.A.201410
K182099Delta TT ProLima Corporate S.P.A.20183
K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152
K172456Bone Screws 6.5mmLima Corporate S.P.A.20181
K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250
K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190

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 18 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
  • 20 of the 77 ancestors have a recall of any class.
  • Of its descendants, K141395 (Lima Corporate S.P.A., 2014) has gone furthest, with 10 descendants of its own.
  • 17 other devices also cite its predicate K091508.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

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.

Also cleared against K091508

17 other devices cite the same predicate.

  • K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd. · 2022
  • K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 20201 recall
  • K173380b-ONE® Total Hip SystemB-One Ortho, Corp. · 2018
  • K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
  • K172456Bone Screws 6.5mmLima Corporate S.P.A. · 20182 recalls
  • K163577Ecofit® Hip SystemImplantcast GmbH · 20171 recall

More from Lima Corporate S.P.A.

64 FDA decisions under this applicant name. See the company

  • K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A. · 2026
  • K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A. · 2025
  • K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 2025
  • K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A. · 2025
  • K243615Physica Porous Femoral ComponentsLima Corporate S.P.A. · 2024

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K112898 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112898: Delta TT Cups, Delta TT Liners, 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/K112898

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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