510(k) · Cleared
ClearedEvolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signature Orthopaedics Pty, Ltd.
Cleared on Mar 12, 2026 as substantially equivalent to K001956 (Howmedica Osteonics Corp., 2000) and 6 other predicates after a 188-day review. Its family tree reaches back 14 generations to 1994.
- Decided
- Mar 12, 2026
- Review
- 188 days
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 14 generations to K931641 (1994). 260 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 14 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 10 generations between
- 3 generations backK172501 iNSitu Total Hip SystemTheken Companies, LLC · 2017
- 2 generations backK192071 iNSitu Total Hip SystemTheken Companies, LLC · 2019
- 1 generation backK241690 Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. · 2024
- This deviceK252824 Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball…Signature Orthopaedics Pty, Ltd. · 2026
Show all 14 generations
- Root · 14 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 13 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 12 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 11 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 10 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 9 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- 8 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 7 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- 6 generations backK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- 5 generations backK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- 4 generations backK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- 3 generations backK172501 iNSitu Total Hip SystemTheken Companies, LLC · 2017
- 2 generations backK192071 iNSitu Total Hip SystemTheken Companies, LLC · 2019
- 1 generation backK241690 Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. · 2024
- This deviceK252824 Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball…Signature Orthopaedics Pty, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −13 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −12 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −11 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −10 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −9 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| −8 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| −7 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| −6 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| −5 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| −4 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| −3 | K172501 | iNSitu Total Hip System | Theken Companies, LLC | 2017 | — |
| −2 | K192071 | iNSitu Total Hip System | Theken Companies, LLC | 2019 | — |
| −1 | K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | 2024 | — |
| 0 (this device) | K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 7 | 0 |
| 1993 | 6 | 0 |
| 1994 | 28 | 0 |
| 1995 | 20 | 0 |
| 1996 | 20 | 0 |
| 1997 | 13 | 0 |
| 1998 | 11 | 0 |
| 1999 | 9 | 0 |
| 2000 | 21 | 0 |
| 2001 | 8 | 0 |
| 2002 | 13 | 0 |
| 2003 | 11 | 0 |
| 2004 | 6 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 0 |
| 2007 | 8 | 0 |
| 2008 | 2 | 0 |
| 2009 | 6 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 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 this category? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K001956 | Trident All Poly CupSummary page 6…Primary Predicate • Howmedica Osteonics Corp., Stryker Trident All Poly Cup, K001956 Additional Predicates • Zimmer Biomet, ZCA All-Poly Acetabular Cup, K19… | 2000 |
| * | K191449 | ZCA All-Poly Acetabular CupsSummary page 6…Cup, K001956 Additional Predicates • Zimmer Biomet, ZCA All-Poly Acetabular Cup, K191449 • Signature Orthopaedics, Logical Vit-E Liner, K241690 World Finned Cu… | 2020 |
| * | K241690 | Logical Liner; World Liner; World Knee PatellaSummary page 6…icates • Zimmer Biomet, ZCA All-Poly Acetabular Cup, K191449 • Signature Orthopaedics, Logical Vit-E Liner, K241690 World Finned Cup Primary Predicate… | 2024 |
| * | K201278 | World Hip Stem, World Cup, World LinerSummary page 7…Page 7 === K252824 Page 2 of 4 • Signature Orthopaedics, World Cup, K201278 Additional Predicate • Signature Orthopaedics, Logical-C Cup, K153131… | 2020 |
| * | K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Summary page 7…• Signature Orthopaedics, World Cup, K201278 Additional Predicate • Signature Orthopaedics, Logical-C Cup, K153131 World G-Zero Liner and Oddball Femoral Head Primary Predicate… | 2016 |
| * | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32Summary page 7…World G-Zero Liner and Oddball Femoral Head Primary Predicate • Biomet, G7 Freedom Liners and Freedom Head, K142882 Additional Predicate • Signature Orthopaedics, Signature CoCr Femoral Head,… | 2015 |
| * | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Summary page 7…Head, K142882 Additional Predicate • Signature Orthopaedics, Signature CoCr Femoral Head, K121297 Device Description: The Evolve AP and Evolve AP Vit-E Cups are manufactured of UHMWPE and GUR1020- E respectively and are all-p… | 2012 |
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 32 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 50 of the 259 ancestors have a recall of any class.
- 2 other devices also cite its predicate K001956.
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 (302 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
Signature Orthopaedics’ Origin, Nebula, 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), Origin Cemented 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 as stated in the FDA summary.
https://510kreport.com/device/K252824 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252824: Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252824
Report an extraction error
Are you the manufacturer?
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