510(k) · Cleared
ClearedG7 Dual Mobility System, Active Articulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on May 26, 2016 as substantially equivalent to K150522 (Biomet, Inc., 2015) and 2 other predicates after a 29-day review. Its family tree reaches back 11 generations to 1981. 7 later devices descend from it.
- Decided
- May 26, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K810258 (1981). 60 ancestors in all. 7 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
- 2 generations backK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
- 1 generation backK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
- This deviceK161190 G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK200011 E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK190656 Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK253948 Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
- Descendant · cites it directly · 0 of its ownK243456 ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK240046 Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 5 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 4 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 3 generations backK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
- 2 generations backK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
- 1 generation backK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
- This deviceK161190 G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc. · 2021 · cites it directly1descendant
- K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc. · 2019 · cites it directly1descendant
- K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026 · 2 generations on0descendants
- K243456ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025 · cites it directly0descendants
- K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −7 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −6 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −5 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −4 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −3 | K101336 | E1 Avantage Head | Biomet Manufacturing Corp | 2011 | 1 |
| −2 | K110555 | Arcomxl Active Articulation | Biomet Manufacturing Corp | 2011 | 2 |
| −1 | K150522 | G7 Dual Mobility System | Biomet, Inc. | 2015 | 1 |
| 0 (this device) | K161190 | G7 Dual Mobility System, Active Articulation System | Biomet, Inc. | 2016 | — |
| +1 | K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS | Microport Orthopedics, Inc. | 2021 | — |
| +1 | K190656 | Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings | Zimmer, Inc. | 2019 | 3 |
| +2 | K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | 2026 | — |
| +1 | K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025 | — |
| +2 | K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | Microport Orthopedics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K150522 | G7 Dual Mobility SystemSummary page 4…Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented Legally marketed devices to which substantial equivalence is claimed: x G7 Dual Mobility System (K150522) x E1 Avantage Heads (K101336) x ArComXL Active Articulation Heads (K110555) Device Description The G7 Dual Mobility Syste… | 2015 |
| * | K101336 | E1 Avantage HeadSummary page 4…Cemented or Non-Porous, Uncemented Legally marketed devices to which substantial equivalence is claimed: x G7 Dual Mobility System (K150522) x E1 Avantage Heads (K101336) x ArComXL Active Articulation Heads (K110555) Device Description The G7 Dual Mobility System and Active Articulation System… | 2011 |
| * | K110555 | Arcomxl Active ArticulationSummary page 4…eted devices to which substantial equivalence is claimed: x G7 Dual Mobility System (K150522) x E1 Avantage Heads (K101336) x ArComXL Active Articulation Heads (K110555) Device Description The G7 Dual Mobility System and Active Articulation System are dual articulation systems wherein there are t… | 2011 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS | 2021 | 1 |
| K190656 | Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings | 2019 | 1 |
| K243456 | ONVOY™ Acetabular System | 2025 | 0 |
| K233724 | 28mm/38D MDM X3 Insert for MDM Liner | 2024 | 0 |
| K181491 | Delta Dual Mobility System | 2019 | 0 |
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 35 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 17 of the 60 ancestors have a recall of any class.
- Of its descendants, K200011 (Microport Orthopedics, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K150522.
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. 2016, 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?
1. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.
The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended for uncemented applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161190 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161190: G7 Dual Mobility System, Active Articulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161190
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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