510(k) · Cleared
ClearedWorld 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 Nov 25, 2024 as substantially equivalent to K201278 (Signature Orthopaedics Pty, Ltd., 2020) and 1 other predicate after a 56-day review. Its family tree reaches back 14 generations to 1994.
- Decided
- Nov 25, 2024
- Review
- 56 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K931641 (1994). 233 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 deviceK243162 World LinerSignature Orthopaedics Pty, Ltd. · 2024
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 deviceK243162 World LinerSignature Orthopaedics Pty, Ltd. · 2024
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) | K243162 | World Liner | Signature Orthopaedics Pty, Ltd. | 2024 | — |
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 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 6 | 0 |
| 1993 | 6 | 0 |
| 1994 | 28 | 0 |
| 1995 | 20 | 0 |
| 1996 | 20 | 0 |
| 1997 | 13 | 0 |
| 1998 | 11 | 0 |
| 1999 | 9 | 0 |
| 2000 | 17 | 0 |
| 2001 | 6 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 6 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K201278 | World Hip Stem, World Cup, World LinerSummary page 5…sthesis (LPH) Predicate Device: Substantial equivalence to the following device is claimed, • Signature Orthopaedics World Liner (K201278) - Primary Predicate • Signature Orthopaedics World Liner (K24169… | 2020 |
| * | K241690 | Logical Liner; World Liner; World Knee PatellaSummary page 5…• Signature Orthopaedics World Liner (K201278) - Primary Predicate • Signature Orthopaedics World Liner (K241690) - Additional Predicate Device Description: The primary purpose of this Special 510(… | 2024 |
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 30 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 44 of the 232 ancestors have a recall of any class.
- 2 other devices also cite its predicate K201278.
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. 2024, 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 (111 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' World Cup components are intended for cementless fixation only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243162 · printed Nov 3, 2026
Cite this page
510(k) Report. “K243162: World Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K243162
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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