510(k) · Cleared
ClearedSpineGuard DSG Zavation Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineguard S.A. · HBG Drills, Burrs, Trephines & Accessories (Manual)
Cleared on Jan 12, 2017 as substantially equivalent to K152747 (Spineguard S.A., 2016) after a 90-day review. Its family tree reaches back 7 generations to 1993. 2 later devices descend from it.
- Decided
- Jan 12, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- HBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K921979 (1993). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK921979 Root ZXJ. Morita USA, Inc. · 1993
- 6 generations backK972407 Root Apex LocatorToei Electric Co., Ltd. · 1997
- 5 generations backK022020 Justwo Model Tme-601 Root Apex LocatorToei Electric Co., Ltd. · 2002
- 4 generations backK030526 Pediguard Nerve Detector SystemSpine Vision, Inc. · 2004
- 3 generations backK123390 Pediguard Nerve Detector SystemSpineguard S.A. · 2013
- 2 generations backK143159 Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2…Spineguard S.A. · 2015
- 1 generation backK152747 DSG Threaded Drill SystemSpineguard S.A. · 2016
- This deviceK162884 SpineGuard DSG Zavation Screw SystemSpineguard S.A. · 2017
- Descendant · cites it directly · 1 of its ownK201454 DSG Connect TechnologySpineguard S.A. · 2021
- Descendant · 2 generations on · 0 of its ownK222106 Waypoint GPSWaypoint Orthopedics, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −7 | K921979 | Root ZX | J. Morita USA, Inc. | 1993 | — |
| −6 | K972407 | Root Apex Locator | Toei Electric Co., Ltd. | 1997 | — |
| −5 | K022020 | Justwo Model Tme-601 Root Apex Locator | Toei Electric Co., Ltd. | 2002 | — |
| −4 | K030526 | Pediguard Nerve Detector System | Spine Vision, Inc. | 2004 | — |
| −3 | K123390 | Pediguard Nerve Detector System | Spineguard S.A. | 2013 | — |
| −2 | K143159 | Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated… | Spineguard S.A. | 2015 | — |
| −1 | K152747 | DSG Threaded Drill System | Spineguard S.A. | 2016 | — |
| 0 (this device) | K162884 | SpineGuard DSG Zavation Screw System | Spineguard S.A. | 2017 | — |
| +1 | K201454 | DSG Connect Technology | Spineguard S.A. | 2021 | — |
| +2 | K222106 | Waypoint GPS | Waypoint Orthopedics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 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 HBG? 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 HBG device
- #1 K252696 Legacyscore 12.2 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K152747 | DSG Threaded Drill SystemSummary page 4…s) Classification Panel: Neurology Regulatory Class: Class II Product Code: HBG Predicate and Reference Devices SpineGuard, S.A. DSGTM Threaded Drill System (K152747, Predicate) Zavation Spinal System (K153404, Reference) Device Description The DSG™ Zavation Screw System is a mo… | 2016 |
| † | K153404 | Zavation Spinal System | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201454 | DSG Connect Technology | 2021 | 1 |
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 2.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K201454 (Spineguard S.A., 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K152747.
How does its category compare?
All HBG devicesHBG Drills, Burrs, Trephines & Accessories (Manual): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HBG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBG
Too few HBG 510(k)s in any year since 2007 to give a median.
Recalls per year · HBG
9in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBG
2in 2025
MAUDE reports naming product code HBG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 14 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 14 | 5 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 9 | 3 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The DSG™ Zavation Screw System is indicated for use with Zavation pedicle screws during pedicle screw insertion to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the pedicle screw and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The DSG™ Zavation Screw System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine, with options of direct insertion of the screw in bone or after a step of preparation of the pilot hole with sensor equipped instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162884: SpineGuard DSG Zavation Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162884
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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