510(k) · Cleared
ClearedSignaSure Dual Mobility System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signature Orthopaedics Pty, Ltd. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Jan 13, 2023 as substantially equivalent to K103233 (Howmedica Osteonics Corp., 2011) and 6 other predicates after a 325-day review. Its family tree reaches back 9 generations to 1993. 1 later device descends from it.
- Decided
- Jan 13, 2023
- Review
- 325 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K930712 (1993). 34 ancestors in all, the oldest K913231 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 5 generations between
- 3 generations backK100555 Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc. · 2010 · Recalled
- 2 generations backK142675 CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf · 2015
- 1 generation backK211742 SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd. · 2022
- This deviceK220495 SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK243456 ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 8 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 7 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 6 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 5 generations backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
- 4 generations backK073150 Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008
- 3 generations backK100555 Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc. · 2010 · Recalled
- 2 generations backK142675 CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf · 2015
- 1 generation backK211742 SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd. · 2022
- This deviceK220495 SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K243456ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −8 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −7 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −6 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −5 | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| −4 | K073150 | Apex-LNK Poly Acetabular Cup Liners | Omni Life Science, Inc. | 2008 | — |
| −3 | K100555 | Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK | Omni Life Science, Inc. | 2010 | 1 |
| −2 | K142675 | CI../..X liner for NOVAE Dual Mobility Acetabular Cup | Serf | 2015 | — |
| −1 | K211742 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2022 | — |
| 0 (this device) | K220495 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2023 | — |
| +1 | K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K103233 | Modular Dual Mobility Liner, X3 Acetabular InsertSummary page 5…Uncemented (LZO) Predicate Devices: Primary Predicate • Stryker Modular Dual Mobility (MDM) Insert and Polyethylene (K103233, K112556) Additional Predicates • Serf Novae Dual Mobility Acetabular Cup (K111572)… | 2011 |
| * | K112556 | Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 InsertsSummary page 5…ed (LZO) Predicate Devices: Primary Predicate • Stryker Modular Dual Mobility (MDM) Insert and Polyethylene (K103233, K112556) Additional Predicates • Serf Novae Dual Mobility Acetabular Cup (K111572)… | 2011 |
| * | K111572 | Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH…Summary page 5…nd Polyethylene (K103233, K112556) Additional Predicates • Serf Novae Dual Mobility Acetabular Cup (K111572) • Serf CI../..X liner for Novae Dual Mobility Acetabular Cup (K142675)… | 2011 |
| * | K142675 | CI../..X liner for NOVAE Dual Mobility Acetabular CupSummary page 5…• Serf Novae Dual Mobility Acetabular Cup (K111572) • Serf CI../..X liner for Novae Dual Mobility Acetabular Cup (K142675) • Stryker Restoration Anatomic Dual Mobility (ADM) System (K072020, K093644)… | 2015 |
| * | K072020 | Restoration Adm SystemSummary page 5…l Mobility Acetabular Cup (K142675) • Stryker Restoration Anatomic Dual Mobility (ADM) System (K072020, K093644) • Signature Orthopaedics SignaSure Dual Mobility System (K211742)… | 2007 |
| * | K093644 | Restoration Adm System X3 AcetabularSummary page 5…y Acetabular Cup (K142675) • Stryker Restoration Anatomic Dual Mobility (ADM) System (K072020, K093644) • Signature Orthopaedics SignaSure Dual Mobility System (K211742)… | 2009 |
| * | K211742 | SignaSure Dual Mobility SystemSummary page 5…ility (ADM) System (K072020, K093644) • Signature Orthopaedics SignaSure Dual Mobility System (K211742) Reference Predicate • Signature Orthopaedics Logical C-Series Cup (K153131)… | 2022 |
| † | K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner… | 2016 |
| † | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series… | 2012 |
| † | K150522 | G7 Dual Mobility System | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243456 | ONVOY™ Acetabular System | 2025 | 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 30 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 7 of the 34 ancestors have a recall of any class.
- Of its descendants, K243456 (Globus Medical, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K103233.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: * Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis * Inflammatory joint disease including rheumatoid arthritis * Correction of functional deformity…
Read the full statement (310 words)
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:
* Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
* Inflammatory joint disease including rheumatoid arthritis
* Correction of functional deformity including congenital hip dysplasia
* Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
» Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
* Dislocation risks (when used with SignaSure range)
Signature Orthopaedics’ Origin, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.
Signature Orthopaedics’ Evolve, Cemented TSI (both CoCr and HNSS variants), and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.
Signature Orthopaedics’ SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics’ Logical/World Acetabular Cup to provide dual mobility articulation.
Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Signature Orthopaedics’ Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
* Acute femoral head or neck fracture
* Fracture dislocation of the hip
* Avascular necrosis of the femoral head
* Non-union of femoral neck fractures
* Certain high subcapital and femoral neck fractures in the elderly
* Degenerative arthritis involving only the femoral head
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220495: SignaSure Dual Mobility System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220495
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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