510(k) · Cleared
ClearedReflection Constrained Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Cleared on Dec 19, 2002 after a 199-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Dec 19, 2002
- Review
- 199 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 5 citing it directly.
- This deviceK021803 Reflection Constrained LinerSmith & Nephew, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK153131 Logical C-Series Acetabular Shell, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd. · 2016
- Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 2 of its ownK241690 Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK122139 Smith & Nephew R3 Constrained LinersSmith & Nephew, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK252824 Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball…Signature Orthopaedics Pty, Ltd. · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd. · 2016 · cites it directly4descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
- K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd. · 2024 · 2 generations on2descendants
- K122139Smith & Nephew R3 Constrained LinersSmith & Nephew, Inc. · 2012 · cites it directly1descendant
- K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021803 | Reflection Constrained Liner | Smith & Nephew, Inc. | 2002 | — |
| +1 | K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical… | Signature Orthopaedics Pty, Ltd. | 2016 | — |
| +1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +2 | K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | 2024 | — |
| +1 | K122139 | Smith & Nephew R3 Constrained Liners | Smith & Nephew, Inc. | 2012 | — |
| +2 | K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 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 KWZ? 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 KWZ device
- #1 K241461 Mpact Constrained Linerscore 15.5 · 10 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | — | Reflection Acetabular Component Named without a submission number | |
| * | — | Johnson & Johnson S-Rom Poly-Dial Constrained Liner Named without a submission number | |
| * | — | Osteonics Constrained Acetabular Insert Named without a submission number | |
| * | — | Zimmer Trilogy Acetabular System Named without a submission number |
What descends from it? (12)
See all 125 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner… | 2016 | 4 |
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
| K122139 | Smith & Nephew R3 Constrained Liners | 2012 | 1 |
| K162641 | Smith & Nephew, Inc. R3™ Constrained Liner | 2017 | 0 |
| K123598 | Smith & Nephew, Inc. Hip System Instrumentation | 2013 | 0 |
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, K153131 (Signature Orthopaedics Pty, Ltd., 2016) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KWZ devicesKWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWZ
104in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWZ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWZ
193in 2025
MAUDE reports naming product code KWZ, 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 | 7 | 104 | 0 | 41 |
| 2008 | 1 | — | 0 | 44 |
| 2009 | 1 | — | 0 | 81 |
| 2010 | 1 | — | 8 | 98 |
| 2011 | 1 | — | 0 | 127 |
| 2012 | 1 | — | 1 | 168 |
| 2013 | 0 | — | 0 | 274 |
| 2014 | 0 | — | 0 | 278 |
| 2015 | 0 | — | 0 | 636 |
| 2016 | 1 | — | 0 | 1,180 |
| 2017 | 2 | — | 0 | 477 |
| 2018 | 0 | — | 0 | 283 |
| 2019 | 0 | — | 0 | 532 |
| 2020 | 0 | — | 0 | 288 |
| 2021 | 0 | — | 0 | 216 |
| 2022 | 0 | — | 0 | 158 |
| 2023 | 0 | — | 1 | 164 |
| 2024 | 1 | — | 0 | 145 |
| 2025 | 1 | — | 0 | 193 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Reflection Constrained Liner is a cemented or uncemented prosthesis intended to replace a hip joint. The Reflection Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intraoperative instability and for whom all other options to constrained acetabular components have been considered. The components subject of this notification are to be used with the Reflection Acetabular System, which is indicated for use with or without cement, and includes single use devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021803 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021803: Reflection Constrained Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021803
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