510(k) · Cleared
ClearedImboki Knee Instrument System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signature Orthopaedics Pty, Ltd. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jan 17, 2019 as substantially equivalent to K180750 (Signature Orthopaedics Pty, Ltd., 2018) after a 241-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Jan 17, 2019
- Review
- 241 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K180750 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backK180750 World Knee SystemSignature Orthopaedics Pty, Ltd. · 2018
- This deviceK181338 Imboki Knee Instrument SystemSignature Orthopaedics Pty, Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K180750 | World Knee System | Signature Orthopaedics Pty, Ltd. | 2018 | — |
| 0 (this device) | K181338 | Imboki Knee Instrument System | Signature Orthopaedics Pty, Ltd. | 2019 | — |
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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K180750 | World Knee SystemSummary page 4…is prosthesis (JWH) Predicate Devices: Primary Predicate • World Total Knee System (K180750) Device Description: The Imboki Knee Instrument System is a simplified instrument set containing accessory… | 2018 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K180750.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
Signature Orthopaedics Imboki Knee Instrument System are accessory devices intended to be used to assist the implantation of Signature Orthopaedics’ World Total Knee System and its cleared indications for use. The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient’s need for knee replacement should be due to one or more of the following…
Read the full statement (120 words)
Signature Orthopaedics Imboki Knee Instrument System are accessory devices intended to be used to assist the implantation of Signature Orthopaedics’ World Total Knee System and its cleared indications for use.
The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient’s need for knee replacement should be due to one or more of the following conditions:
• Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
• Inflammatory degenerative joint disease including rheumatoid arthritis.
• Functional deformity such as varus, valgus or flexion deformities.
• Revision procedures where other treatments or devices have failed.
• Fractures that are unmanageable using other techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181338: Imboki Knee Instrument System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181338
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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