510(k) Report

510(k) · Cleared

Cleared

Trident® Tritanium® PST® Acetabular Shells

K142606510(k) TraditionalCleared Jan 26, 2015133-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

Mako Surgical Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jan 26, 2015 as substantially equivalent to K112802 (Pipeline Orthopedics, 2012) and 3 other predicates after a 133-day review. Its family tree reaches back 8 generations to 1994.

Decided
Jan 26, 2015
Review
133 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
4

Its longest line of descent runs back 8 generations to K931641 (1994). 90 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2001: 3 other ancestors1998: 6 other ancestors2011: 1 other ancestor2007: 1 other ancestor2006: 1 other ancestor2005: 2 other ancestors2000: 10 other ancestors1995: 12 other ancestors1994: 15 other ancestors2003: 3 other ancestors2002: 1 other ancestor1999: 5 other ancestors1997: 5 other ancestors1996: 6 other ancestors1993: 4 other ancestors1986: 2 other ancestors1992: 1 other ancestor1990: 1 other ancestor1981: 1 other ancestor1985: 1 other ancestorK931641 · 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. · 2003×2: 2 generations cleared close together, K041906 (2004), K042842 (2004) K102487 · Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated, Press-Fit, Size 19/20 · Exactech, Inc. · 2010K112802 · Pipeline Total Hip System · Pipeline Orthopedics · 20121980199020002010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 10 other ancestors3 generations back: 19 other ancestors4 generations back: 24 other ancestors5 generations back: 11 other ancestors6 generations back: 15 other ancestors K112802 · Pipeline Total Hip System · Pipeline Orthopedics · 2012K102487 · Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated, Press-Fit, Size 19/20 · Exactech, Inc. · 2010K042842 · Novation 12/14 Press-Fit Femoral Stem · Exactech, Inc. · 2004K041906 · 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 backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
  7. 2 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
  8. 1 generation backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
  9. This deviceK142606 Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp. · 2015
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
−3K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc.2004—
−2K102487Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma…Exactech, Inc.2010—
−1K112802Pipeline Total Hip SystemPipeline Orthopedics2012—
0 (this device)K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198510
198620
199010
199210
199340
1994150
1995120
199660
199750
199860
199950
2000100
200130
200210
200330
200520
200610
200710
200810
201110
FIG. 1 — Lineage of K142606, 1994–2015Source: 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? (4)

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
*K112802Pipeline Total Hip System
Summary page 4
…owing predicate devices: Device Description 510(k) Numbers PST® Acetabular Shells (and dome hole plug) K112802 Trident® Tritanium®, Trident® PSL® and Trident® K081171, K983382, K013676 Hemispherical Shells…
Pipeline Orthopedics2012—
*K081171Tritanium Acetabular Shell System
Summary page 4
…510(k) Numbers PST® Acetabular Shells (and dome hole plug) K112802 Trident® Tritanium®, Trident® PSL® and Trident® K081171, K983382, K013676 Hemispherical Shells 510(k) Summary, Page 1 of 3…
Howmedica Osteonics Corp.2008—
*K983382Osteonics HA Generation II Acetabular Component System
Summary page 4
…510(k) Numbers PST® Acetabular Shells (and dome hole plug) K112802 Trident® Tritanium®, Trident® PSL® and Trident® K081171, K983382, K013676 Hemispherical Shells 510(k) Summary, Page 1 of 3…
Osteonics Corp.19984
*K013676Trident Hemispherical Acetabular Shells
Summary page 4
…10(k) Numbers PST® Acetabular Shells (and dome hole plug) K112802 Trident® Tritanium®, Trident® PSL® and Trident® K081171, K983382, K013676 Hemispherical Shells 510(k) Summary, Page 1 of 3…
Howmedica Osteonics Corp.20018

Also cleared against K112802: 5 other devices →

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 21 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
  • 20 of the 90 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K112802.

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. 2015, 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 Trident® Tritanium® PST® Acetabular Shell System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to: • A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia; • Acute traumatic fracture of the femoral head or neck; • Failed previous hip surgery including joint reconstruction, internal fixation…

Read the full statement (97 words)

The Trident® Tritanium® PST® Acetabular Shell System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis,

or congenital hip dysplasia;

• Acute traumatic fracture of the femoral head or neck;

• Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface

replacement arthroplasty or total hip replacement.

The Trident® Tritanium® PST® Acetabular Shell is intended for cementless or cemented fixation. The porous structured

surface provides biological fixation when used in a cementless application.

Indications for use as stated in the FDA summary.

Also cleared against K112802

5 other devices cite the same predicate.

  • K162719iTotal® Hip Replacement SystemConformis, Inc. · 20174 recalls
  • K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
  • K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc. · 2013
  • K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics · 2013
  • K122158PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012

More from Mako Surgical Corp.

33 FDA decisions under this applicant name. See the company

  • K260222Mako Total Knee ApplicationMako Surgical Corp. · 2026
  • K250608Mako Total Knee Application (3.0); Hybrid Tip PointerMako Surgical Corp. · 2025
  • K243751Mako Total Hip Application 5.0Mako Surgical Corp. · 2025
  • K242373Mako Shoulder Application (1.0)Mako Surgical Corp. · 2024
  • K241011Mako Total Knee ApplicationMako Surgical Corp. · 20241 recall

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/K142606 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142606: Trident® Tritanium® PST® Acetabular Shells.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142606

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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