510(k) Report

510(k) · Cleared

Cleared

Tregor Dual Mobility Acetabular System

K111981510(k) TraditionalCleared Oct 12, 2012458-day reviewClass II21 CFR 888.3353

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

Aston Medical · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Oct 12, 2012 as substantially equivalent to K070278 (Plus Orthopedics AG, 2007) and 3 other predicates after a 458-day review. Its family tree reaches back 9 generations to 1981.

Decided
Oct 12, 2012
Review
458 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
4

Its longest line of descent runs back 9 generations to K810258 (1981). 40 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 3 other ancestors2007: 4 other ancestors2005: 3 other ancestors1999: 1 other ancestor2008: 1 other ancestor2002: 2 other ancestors1997: 1 other ancestor2004: 1 other ancestor2003: 2 other ancestors1995: 4 other ancestors1994: 4 other ancestors1993: 1 other ancestor1992: 3 other ancestors1991: 1 other ancestorReference device: K092198 · Cormet Cementless Resurfacing Femoral Head · Corin USA · 2010K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalled×2: 2 generations cleared close together, K042051 (2005), K051411 (2005) K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K100048 · E1 Antioxidant Infused Technology · Biomet Manufacturing Corp · 2010K101336 · E1 Avantage Head · Biomet Manufacturing Corp · 2011 · recalled1980198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 4 other ancestors4 generations back: 12 other ancestors5 generations back: 6 other ancestors6 generations back: 1 other ancestor K101336 · E1 Avantage Head · Biomet Manufacturing Corp · 2011 · recalledK100048 · E1 Antioxidant Infused Technology · Biomet Manufacturing Corp · 2010K073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K051411 · Arcomxl Polyethylene Liners and Biolox Delta Heads · Biomet, Inc. · 2005 · recalledK042051 · Arcomxl Polyethylene Liners · Biomet, Inc. · 2005 · recalledK032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−50
  1. Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 5 generations between
  3. 3 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
  4. 2 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
  5. 1 generation backK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
  6. This deviceK111981 Tregor Dual Mobility Acetabular SystemAston Medical · 2012
Show all 9 generations
  1. Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 6 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 5 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 4 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 3 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
  8. 2 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
  9. 1 generation backK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
  10. This deviceK111981 Tregor Dual Mobility Acetabular SystemAston Medical · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−8K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−7K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−6K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−5K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−4K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−3K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007—
−2K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010—
−1K101336E1 Avantage HeadBiomet Manufacturing Corp20111
0 (this device)K111981Tregor Dual Mobility Acetabular SystemAston Medical2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199230
199310
199440
199540
199710
199910
200220
200320
200410
200530
200740
200810
200930
FIG. 1 — Lineage of K111981, 1981–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 LZO? 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 LZO device

  1. #1 K192827 Quadra-Pscore 19.3 · 10 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? (5)

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
*K070278Polarcup Dual Mobility System
Summary page 4
…lence: The TREGOR® Dual Mobility Acetabular System is substantially equivalent to the previously cleared devices: Plus Orthopedics POLARCIJP9 Dual Mobility System (K070278), Stryker@ RestorationTM ADM X39® Mobile Bearing HipTM System (K(072020), Medacta Versafit®@ Cup Double Mobility (K083 116), Bi…
Plus Orthopedics AG2007—
*K072020Restoration Adm System
Summary page 1
…Predicate Devices: K(070278 Plus Orthopedics AG, USA - POLARCUP® Dual Mobility System- cleared 04/16/2007 K(072020 Stryker@, Inc. (formerly Howmedica Osteonics Cowp.) - Restoration ADM X30 Mobile Bearing…
Howmedica Osteonics Corp.20071
*K083116Versafit Cup Double Mobility System
Summary page 4
…rthopedics POLARCIJP9 Dual Mobility System (K070278), Stryker@ RestorationTM ADM X39® Mobile Bearing HipTM System (K(072020), Medacta Versafit®@ Cup Double Mobility (K083 116), Biomet E IT"Active Articulation Dual Mobility Hip System (K10 1336), and the pte-1976 Medical Device Amendment to the Food,…
Medacta International S.A.20092
*K101336E1 Avantage Head
Summary page 2
…from disclosure from 21 CFR 20.61 1-- K101336 Biomet Manufacturing Corp., El® Active Articulation Dual Mobility Hip System - cleared 01/14/2011 K(092 19…
Biomet Manufacturing Corp20111
*—Charnley acetabular cup
Named without a submission number
—
†K092198Cormet Cementless Resurfacing Femoral HeadCorin USA2010—

Also cleared against K070278: 7 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 31 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
  • 14 of the 40 ancestors have a recall of any class.
  • 7 other devices also cite its predicate K070278.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-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 · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

What is it indicated for?

The TREGOR® Dual Mobility Acetabular System is indicated for hip pathologies requiring total hip replacement (THR): * Non inflammatory or rheumatoid arthritis; * Osteonecrosis of femoral head; * Hip deformity affecting its function; * Non-union head fracture or complex pertrochanteric fracture that are unmanageable using other techniques; * Revision of previous hip surgery; * Dislocation risks (e.g., ASA score : 3) The TREGOR® Dual Mobility Acetabular…

Read the full statement (268 words)

The TREGOR® Dual Mobility Acetabular System is indicated for hip pathologies requiring total hip replacement (THR):

* Non inflammatory or rheumatoid arthritis;

* Osteonecrosis of femoral head;

* Hip deformity affecting its function;

* Non-union head fracture or complex pertrochanteric fracture that are unmanageable using other techniques;

* Revision of previous hip surgery;

* Dislocation risks (e.g., ASA score : 3)

The TREGOR® Dual Mobility Acetabular System hip prosthesis is intended for use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

Method of fixation:

When used with the TREGOR® Standard acetabular cup with dual Ti/HA coating, the TREGOR® Dual Mobility Acetabular System is for cementless use only and press fit application.

When used with the TREGOR® with Blades acetabular cup with dual Ti/HA coating, the TREGOR® Dual Mobility Acetabular System is for cementless use only and press fit application. The TREGOR® with Blades acetabular cup has blades for additional fixation.

When used with the TREGOR® + acetabular cup with dual Ti/HA coating, the TREGOR® Dual Mobility Acetabular System is for cementless use only and press fit application. The TREGOR® + acetabular cup has blades and screws for additional fixation.

When used with the TREGOR® Tripod acetabular cup with dual Ti/HA coating, the TREGOR® Dual Mobility Acetabular System is for cementless use only and press fit application. The TREGOR® Tripod acetabular cup has pegs and screw for additional fixation.

When used with the TREGOR® Medial Cup acetabular cup, the TREGOR® Dual Mobility Acetabular System is for cemented use only. An optional acetabular reinforcement cross maybe be used with the TREGOR® Medial Cup, also for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K070278

7 other devices cite the same predicate.

  • K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 20221 recall
  • K181491Delta Dual Mobility SystemLima Corporate S.P.A. · 2019
  • K171934Birmingham Hip (BH) Dual Mobility InsertSmith & Nephew, Inc. · 2017
  • K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 20132 recalls
  • K110135Polarcup Dual Mobility SystemSmith & Nephew, Inc. · 2011
  • K111572Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility…Serf · 20115 recalls

More from Aston Medical

3 FDA decisions under this applicant name. See the company

  • K133462Duocentric Reversed Shoulder ProsthesisAston Medical · 2014
  • K103251Duocentric ReversedAston Medical · 2011

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K111981 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111981: Tregor Dual Mobility 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/K111981

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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