510(k) · Cleared
ClearedBrisbane ALIF Device, Gladstone ALIF Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signature Orthopaedics Pty, Ltd. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Nov 29, 2017 as substantially equivalent to K141942 (Centinel Spine, Inc., 2014) and 4 other predicates after a 147-day review. Its family tree reaches back 16 generations to 1984.
- Decided
- Nov 29, 2017
- Review
- 147 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K841189 (1984). 179 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 2 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 1 generation backK141942 Midline II TICentinel Spine, Inc. · 2014
- This deviceK172019 Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd. · 2017
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 6 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 5 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 4 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 3 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 2 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 1 generation backK141942 Midline II TICentinel Spine, Inc. · 2014
- This deviceK172019 Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −6 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −5 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −4 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −3 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −2 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −1 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 14 | 0 |
| 2004 | 23 | 0 |
| 2005 | 15 | 0 |
| 2006 | 8 | 0 |
| 2007 | 11 | 0 |
| 2008 | 23 | 0 |
| 2009 | 13 | 0 |
| 2010 | 7 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2017 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K141942 | Midline II TISummary page 4…80: Intervertebral Body Fusion Device (OVD) Predicate Primary Predicate: Devices: Spine MIDLINE II-Ti™ (K141942) Additional Predicates: Benvenue Medical Inc Luna 360 Interbody System (… | 2014 |
| * | K142023 | Luna Interbody SystemSummary page 4…Spine MIDLINE II-Ti™ (K141942) Additional Predicates: Benvenue Medical Inc Luna 360 Interbody System (K142023) K2M Chesapeake Spinal System (K133494) Spineart DYNAMIK Lumbar Interbody… | 2014 |
| * | K133494 | Chesapeake Spinal SystemSummary page 4…Additional Predicates: Benvenue Medical Inc Luna 360 Interbody System (K142023) K2M Chesapeake Spinal System (K133494) Spineart DYNAMIK Lumbar Interbody Device (K081888) Reference Predicate:… | 2014 |
| * | K081888 | Dynamik Intervertebral Body Fusion DeviceSummary page 4…a 360 Interbody System (K142023) K2M Chesapeake Spinal System (K133494) Spineart DYNAMIK Lumbar Interbody Device (K081888) Reference Predicate: Signature Orthopaedics NOOSA Anterior Lumbar Plate… | 2009 |
| * | K163625 | NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS… Cleared while this submission was under review Summary page 4…1888) Reference Predicate: Signature Orthopaedics NOOSA Anterior Lumbar Plate Screw (K163625) Device Description: The Signature Orthopaedics Brisbane ALIF and Gladstone ALIF cages are manufactured fro… | 2017 |
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 33 years and passes through 14 companies; a new generation was cleared every 1.0 years on median.
- 21 of the 179 ancestors have a recall of any class.
- 3 other devices also cite its predicate K141942.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The Signature Orthopaedics Brisbane ALIF and Gladstone ALIF systems are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should…
Read the full statement (143 words)
The Signature Orthopaedics Brisbane ALIF and Gladstone ALIF systems are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The Brisbane and Gladstone ALIF systems may be used as stand-alone devices or in conjunction with supplemental fixation. When used as a stand-alone device the subject devices must be used with all three screws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172019: Brisbane ALIF Device, Gladstone ALIF Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172019
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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