510(k) · Cleared
ClearedEvolve UniPolar Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signature Orthopaedics Pty, Ltd. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Mar 17, 2015 as substantially equivalent to K121297 (Signature Orthopaedics Pty, Ltd., 2012) and 3 other predicates after a 132-day review. Its family tree reaches back 12 generations to 1994. 1 of the 204 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Mar 17, 2015
- Review
- 132 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K941847 (1994). 203 ancestors in all, the oldest K791125 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 204 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 8 generations between
- 3 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 2 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 1 generation backK102172 Msa Hip SystemGlobal Manufacturing Technology · 2011
- This deviceK143184 Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK201047 Fusion Taper SystemSignature Orthopaedics Pty, Ltd. · 2021
Show all 12 generations
- Root · 12 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 11 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 10 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 9 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 8 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 7 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 6 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 5 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 4 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 3 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 2 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 1 generation backK102172 Msa Hip SystemGlobal Manufacturing Technology · 2011
- This deviceK143184 Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd. · 2015
Class I recalls in this family
- K091423 Profemur Hip System Modular Necks2 generations back · 2009
Most influential descendants
Showing 1 of 1 · See all- K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −11 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −10 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −9 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −8 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −7 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −6 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −5 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −4 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −3 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −2 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −1 | K102172 | Msa Hip System | Global Manufacturing Technology | 2011 | — |
| 0 (this device) | K143184 | Evolve UniPolar Head | Signature Orthopaedics Pty, Ltd. | 2015 | — |
| +1 | K201047 | Fusion Taper System | Signature Orthopaedics Pty, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 2 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 26 | 0 |
| 1995 | 15 | 0 |
| 1996 | 15 | 0 |
| 1997 | 10 | 0 |
| 1998 | 9 | 0 |
| 1999 | 8 | 0 |
| 2000 | 17 | 0 |
| 2001 | 8 | 0 |
| 2002 | 11 | 0 |
| 2003 | 9 | 0 |
| 2004 | 8 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 1 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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.
1 device in this family has a Class I recall. 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 KWL device
- #1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Summary page 4…ollowing devices is claimed: x Signature Orthopaedics Origin Total Hip System CoCr Femoral Head (K121297) x Signature Orthopaedics BiPolar Head (K133370) x Smith &… | 2012 |
| * | K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Summary page 4…edics Origin Total Hip System CoCr Femoral Head (K121297) x Signature Orthopaedics BiPolar Head (K133370) x Smith & Nephew Tandem UniPolar Head (K896580) x Global M… | 2014 |
| * | K896580 | Uni-Polar HeadSummary page 4…ad (K121297) x Signature Orthopaedics BiPolar Head (K133370) x Smith & Nephew Tandem UniPolar Head (K896580) x Global Manufacturing Technology MSA Hip System (K10217… | 1990 |
| * | K102172 | Msa Hip SystemSummary page 4…x Smith & Nephew Tandem UniPolar Head (K896580) x Global Manufacturing Technology MSA Hip System (K102172) Device Description: The Evolve™ UniPolar Head is a metallic (per ISO 5832-12) ball with a tapered bore. Th… | 2011 |
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 |
|---|---|---|---|
| K201047 | Fusion Taper System | 2021 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 50 of the 202 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K201047 (Signature Orthopaedics Pty, Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K121297.
How does its category compare?
All KWL devicesKWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · KWL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWL
32in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWL
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWL
29in 2025
MAUDE reports naming product code KWL, 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 | — | 36 | 11 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 2 | 21 |
| 2010 | 0 | — | 0 | 55 |
| 2011 | 2 | — | 0 | 51 |
| 2012 | 1 | — | 0 | 62 |
| 2013 | 0 | — | 0 | 89 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 1 | — | 1 | 223 |
| 2016 | 0 | — | 0 | 210 |
| 2017 | 0 | — | 2 | 347 |
| 2018 | 2 | — | 0 | 294 |
| 2019 | 1 | — | 0 | 415 |
| 2020 | 1 | — | 0 | 270 |
| 2021 | 0 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 99 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 1 | — | 0 | 143 |
| 2025 | 3 | 32 | 0 | 29 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Signature Orthopaedics’ Evolve UniPolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head is 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 as stated in the FDA summary.
https://510kreport.com/device/K143184 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143184: Evolve UniPolar Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143184
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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