510(k) · Cleared
ClearedLongboard Revision Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signature Orthopaedics Pty, Ltd. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Aug 7, 2025 as substantially equivalent to K151902 (Smith & Nephew, Inc., 2015) and 2 other predicates after a 314-day review. Its family tree reaches back 8 generations to 1985.
- Decided
- Aug 7, 2025
- Review
- 314 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K850055 (1985). 64 ancestors in all, the oldest K840643 (1984). No later device cites it as a predicate yet.
- Root · 8 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 7 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 6 generations backK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- 5 generations backK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
- 4 generations backK072417 Smith & Nephew Mis Hip StemSmith & Nephew, Inc. · 2008 · Recalled
- 3 generations backK081124 MDF Revision Hip SystemSmith & Nephew, Inc. · 2008 · Recalled
- 2 generations backK113789 Modular Proximally Fluted Hip StemSmith & Nephew, Inc. · 2012 · Recalled
- 1 generation backK151902 REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc. · 2015
- This deviceK243021 Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −7 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −6 | K964769 | Versys Hip System--Fiber Metal Taper Hip Prosthesis | Zimmer, Inc. | 1997 | — |
| −5 | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | Zimmer, Inc. | 2003 | 2 |
| −4 | K072417 | Smith & Nephew Mis Hip Stem | Smith & Nephew, Inc. | 2008 | 1 |
| −3 | K081124 | MDF Revision Hip System | Smith & Nephew, Inc. | 2008 | 2 |
| −2 | K113789 | Modular Proximally Fluted Hip Stem | Smith & Nephew, Inc. | 2012 | 1 |
| −1 | K151902 | REDAPT¿ Revision Femoral System | Smith & Nephew, Inc. | 2015 | — |
| 0 (this device) | K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 8 | 0 |
| 1995 | 5 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K151902 | REDAPT¿ Revision Femoral SystemSummary page 6…Substantial equivalence to the following devices is claimed: • Smith & Nephew REDAPTTM Revision Femoral System (K151902) – Primary Predicate • Zimmer Biomet Arcos Interlocking Distal Stem (K1… | 2015 |
| * | K100469 | Arcos Interlocking Distal StemsSummary page 6…em (K151902) – Primary Predicate • Zimmer Biomet Arcos Interlocking Distal Stem (K100469) – Additional Predicate • Signature Orthopaedics Spartan Hip Stem (K192883) –… | 2010 |
| * | K192883 | Spartan Hip StemSummary page 6…omet Arcos Interlocking Distal Stem (K100469) – Additional Predicate • Signature Orthopaedics Spartan Hip Stem (K192883) – Additional Predicate • Signature Orthopaedics Origin Hip Stem, Femor… | 2020 |
| † | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series… | 2012 |
| † | K201278 | World Hip Stem, World Cup, World Liner | 2020 |
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 40 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 21 of the 63 ancestors have a recall of any class.
- 3 other devices also cite its predicate K151902.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
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 (162 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 & fracture non-union or mal-union
• 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, hemiarthroplasty, surface replacement, or total hip replacement
• Dislocation risks (when used with SignaSure Dual Mobility System)
Signature Orthopaedics’ Longboard Revision Stem is intended for individuals undergoing revision surgery of the hip only.
Signature Orthopaedics’ Origin, Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World, Everglade and Longboard Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243021: Longboard Revision Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243021
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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