510(k) · Cleared
ClearedWorld Hip Stem, World Cup, World Liner
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 Sep 21, 2020 after a 131-day review. The summary cites 12 numbers, none of which could be confirmed as its predicate (see the table below). 3 later devices descend from it.
- Decided
- Sep 21, 2020
- Review
- 131 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 12
3 later devices descend from it, 3 citing it directly.
- This deviceK201278 World Hip Stem, World Cup, World LinerSignature Orthopaedics Pty, Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK241690 Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK252824 Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball…Signature Orthopaedics Pty, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243162 World LinerSignature Orthopaedics Pty, Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. · 2024 · cites it directly2descendants
- K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd. · 2026 · cites it directly0descendants
- K243162World LinerSignature Orthopaedics Pty, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K201278 | World Hip Stem, World Cup, World Liner | Signature Orthopaedics Pty, Ltd. | 2020 | — |
| +1 | K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | 2024 | — |
| +1 | K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | 2026 | — |
| +1 | K243162 | World Liner | Signature Orthopaedics Pty, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 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? (12)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K191608 | FDA’s K191608 is Impress Angiographic Catheter Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2019 |
| Kept off the family tree | K199895 | Zimmer Biomet G7 Acetabular Cup System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| Kept off the family tree | K199810 | Signature Orthopaedics Legacy G-PE Acetabular Cup Liner Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| Kept off the family tree | K083131 | FDA’s K083131 is Medos Hilite Reservoir, Model: 4030 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| Kept off the family tree | K090909 | FDA’s K090909 is C-Qur V -Patch Mesh Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| Kept off the family tree | K181290 | FDA’s K181290 is Fusion Bx 2.0 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2018 |
| Kept off the family tree | K183878 | World Cup and World Liner Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| Kept off the family tree | K182828 | FDA’s K182828 is Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2019 |
| Kept off the family tree | K183373 | FDA’s K183373 is Bonebridge Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2019 |
| Kept off the family tree | K176767 | Signature Orthopaedics’ Legacy Acetabular Cup Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| Kept off the family tree | K191387 | FDA’s K191387 is ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2019 |
| Kept off the family tree | K190226 | Signature Orthopaedics’ Legacy G-PE Liners Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| † | K166770 | Zimmer Biomet G7 Acetabular Cup System | |
| † | K177955 | Signature Orthopaedics’ Legacy G-PE 200 Liner |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K241690 (Signature Orthopaedics Pty, Ltd., 2024) has gone furthest, with 2 descendants of its own.
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. 2020, 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?
The Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. The 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 or post-traumatic arthritis • Correction of functional…
Read the full statement (301 words)
The Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. The 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 or post-traumatic 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, reconstructive, hemiarthroplasty, surface replacement, or total replacement
Signature Orthopaedics’ Origin, Aria, Remedy, TSI, Pegasus, Sport, World Hip femoral stems, Signature Cementless Cups, and Signature Cementless Cups, Wical and World Acetabular Cups are intended for cementless fixation only.
Signature Orthopaedics’ Evoke, Cemented TSI (with CCDR variants), Cemented Origin femoral stems and Signature Cemented Cups are intended for cemented fixation only.
Signature Orthopaedics’ Signature Insert is indicated for use with a cementless Signature Orthopaedics’ Wical 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 Bipolar Head and Bipolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum is not required to be replaced. The Evolve Bipolar Head and Bipolar Head are indicated for use for bone fractures or pathologies involving the femoral head/neck 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 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/K201278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201278: World Hip Stem, World Cup, World Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201278
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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