510(k) · Cleared
ClearedNOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signature Orthopaedics Pty, Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 11, 2017 as substantially equivalent to K052546 (Depuy Spine, Inc., 2006) and 2 other predicates after a 232-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Aug 11, 2017
- Review
- 232 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K922543 (1993). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- 2 generations backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 1 generation backK052546 Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc. · 2006
- This deviceK163625 NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate…Signature Orthopaedics Pty, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK181190 Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK172019 Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −2 | K013665 | Pyramid Anterior Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −1 | K052546 | Aegis Anterior Lumbar Plate System | Depuy Spine, Inc. | 2006 | — |
| 0 (this device) | K163625 | NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System… | Signature Orthopaedics Pty, Ltd. | 2017 | — |
| +1 | K181190 | Pinehurst Anterior Cervical Plate System | Signature Orthopaedics Pty, Ltd. | 2019 | — |
| +1 | K172019 | Brisbane ALIF Device, Gladstone ALIF Device | Signature Orthopaedics Pty, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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 |
|---|---|---|---|
| * | K052546 | Aegis Anterior Lumbar Plate SystemSummary page 4…888.3060: Spinal Intervertebral Body Fixation Orthosis (KWQ) Predicate Devices: Primary Predicate • DePuy Spine AEGIS (K052546) Additional Predicate • Medtronic Sofamor Danek PYRAMIDTM (K013665)… | 2006 |
| * | K013665 | Pyramid Anterior Plate Fixation SystemSummary page 4…Predicate • DePuy Spine AEGIS (K052546) Additional Predicate • Medtronic Sofamor Danek PYRAMIDTM (K013665) • Synthes Spine Anterior Tension Band (ATB) (K022791) Reference Predicate… | 2002 |
| * | K022791 | Synthes Anterior Tension Band (Atb) SystemSummary page 4…Additional Predicate • Medtronic Sofamor Danek PYRAMIDTM (K013665) • Synthes Spine Anterior Tension Band (ATB) (K022791) Reference Predicate • Signature Orthopaedics Logical Bone Screw (K121297) Device… | 2002 |
| † | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series… | 2012 |
What descends from it? (2)
2 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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 8.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K181190 (Signature Orthopaedics Pty, Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K052546.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The Signature Orthopaedics NOOSA, NAMBUCCA, and CAIRNS Anterior Lumbar Plate Systems are indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. The devices are intended as temporary fixation devices until fusion is achieved. The subject systems are indicated in the treatment of lumbar or lumbosacral (L1-S1) fixation…
Read the full statement (114 words)
The Signature Orthopaedics NOOSA, NAMBUCCA, and CAIRNS Anterior Lumbar Plate Systems are indicated for use
via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical
approach, below the bifurcation of the great vessels. The devices are intended as temporary fixation devices until fusion is
achieved. The subject systems are indicated in the treatment of lumbar or lumbosacral (L1-S1) fixation for the following
indications: degenerative disc disease (DDD)(as define by back pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), deformities or
curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163625: NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163625
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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