510(k) · Cleared
ClearedBoundary Anterior Lumbar Buttress Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nvision Biomedical Technologies, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Dec 6, 2017 as substantially equivalent to K092659 (Spinal USA, 2009) and 2 other predicates after a 68-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Dec 6, 2017
- Review
- 68 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K953730 (1995). 40 ancestors in all, the oldest K914362 (1992). No later device cites it as a predicate yet.
- Root · 7 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 6 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 5 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
- 4 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
- 3 generations backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
- 2 generations backK151553 Anterior Cervical Plate SystemOsteomed Implantes, Ltda · 2016
- 1 generation backK161524 Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC · 2016
- This deviceK173091 Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −6 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −5 | K040655 | Swift Anterior Cervical Plate System | Depuy Spine, Inc. | 2004 | — |
| −4 | K072546 | Swift Plus Anterior Cervical Plate System | Depuy Spine, Inc. | 2007 | — |
| −3 | K080646 | C-Tek Maxan Anterior Cervical Plate System | Biomet Spine | 2008 | 2 |
| −2 | K151553 | Anterior Cervical Plate System | Osteomed Implantes, Ltda | 2016 | — |
| −1 | K161524 | Tangis Anterior Cervical Plate | Nvision Biomedical Technologies, LLC | 2016 | — |
| 0 (this device) | K173091 | Boundary Anterior Lumbar Buttress Plate | Nvision Biomedical Technologies, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K092659 | Spinal Usa RCS Anterior Lumbar Butress Plate System, Model 22-1001-25Summary page 5…PredicateDeviceName/Manufacturer Number Predicate K092659 RCS®AnteriorButtressPlateSystem/PrecisionSpine,Inc. 9 K133911 AnteriorButtressPlate… | 2009 |
| * | K133911 | Genesys Spine Anterior Buttress Plate SystemSummary page 5…Predicate K092659 RCS®AnteriorButtressPlateSystem/PrecisionSpine,Inc. 9 K133911 AnteriorButtressPlateSystem/GenesysSpine K161524 TangisAnteriorCervicalPlat… | 2014 |
| * | K161524 | Tangis Anterior Cervical PlateSummary page 5…PlateSystem/PrecisionSpine,Inc. 9 K133911 AnteriorButtressPlateSystem/GenesysSpine K161524 TangisAnteriorCervicalPlate/NvisionBiomedicalTechnologies,LLC SUMMARYOFNONͲCLINICALTESTING No… | 2016 |
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 22 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 40 ancestors have a recall of any class.
- 3 other devices also cite its predicate K092659.
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 Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
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/K173091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173091: Boundary Anterior Lumbar Buttress Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173091
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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