510(k) · Cleared
ClearedSynthes Navigable Pedicle Preparation Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine · HAW Neurological Stereotaxic Instrument
Cleared on Dec 17, 2012 as substantially equivalent to K070106 (Brainlab AG, 2007) and 2 other predicates after a 145-day review. Its family tree reaches back 5 generations to 1999. 1 of the 33 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it.
- Decided
- Dec 17, 2012
- Review
- 145 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K983831 (1999). 12 ancestors in all, the oldest K981508 (1998). 20 later devices descend from it, 8 citing it directly. 1 of the 33 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 4 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 3 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 2 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 1 generation backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- This deviceK122211 Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine · 2012
- Descendant · cites it directly · 8 of its ownK191943 SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor…Medos International SARL · 2019
- Descendant · cites it directly · 7 of its ownK201661 Symphony Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2020
- Descendant · cites it directly · 6 of its ownK170937 VIPER PRIME navigated inserterMedos International SARL · 2017
- Descendant · cites it directly · 5 of its ownK212756 Discectomy Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2022
- Descendant · 2 generations on · 4 of its ownK231280 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2023
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3Ddirect predicate · 2007
Most influential descendants
Showing 5 of 20 · See all- K191943SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor SetMedos International SARL · 2019 · cites it directly8descendants
- K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL · 2020 · cites it directly7descendants
- K170937VIPER PRIME navigated inserterMedos International SARL · 2017 · cites it directly6descendants
- K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL · 2022 · cites it directly5descendants
- K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd. · 2023 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −4 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −3 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −2 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −1 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| 0 (this device) | K122211 | Synthes Navigable Pedicle Preparation Instruments | Synthes Spine | 2012 | — |
| +1 | K191943 | SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set | Medos International SARL | 2019 | — |
| +1 | K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2020 | — |
| +1 | K170937 | VIPER PRIME navigated inserter | Medos International SARL | 2017 | — |
| +1 | K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2022 | — |
| +2 | K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments… | CarboFix Orthopedics, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2026 | 2 | 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.
1 device in this family has a Class I recall. 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 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? (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 |
|---|---|---|---|
| * | K070106 | VV Fluoro 3DSummary page 1…Preparation Instruments Classification: Sec. 882.4560 Class 11 Orthopaedic Product Code: OLO, HAW Predicate K070 106 BrainLab VectorVision Fluoro3D System Devices: K050438 Medtronic StealthStation K0031Ill… | 2007 |
| * | K050438 | Stealthstation System UpdateSummary page 1…Class 11 Orthopaedic Product Code: OLO, HAW Predicate K070 106 BrainLab VectorVision Fluoro3D System Devices: K050438 Medtronic StealthStation K0031Ill Stryker SpineMap Device The Navigable Pedicle Preparat… | 2005 |
| * | K003111 | Stryker Navigation System-Spine & Fluoroscopy Modules | 2001 |
What descends from it? (20)
See all 208 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191943 | SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set | 2019 | 8 |
| K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set | 2020 | 7 |
| K170937 | VIPER PRIME navigated inserter | 2017 | 6 |
| K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set | 2022 | 5 |
| K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) | 2023 | 4 |
| K140927 | Universal Navigation Instruments | 2014 | 1 |
| K192133 | Zimmer Biomet Universal Navigation System | 2019 | 0 |
| K190556 | Zimmer Biomet Universal Navigation System | 2019 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070106VV Fluoro 3DBrainlab AG · 2007 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K191943 (Medos International SARL, 2019) has gone furthest, with 8 descendants of its own.
- 9 other devices also cite its predicate K070106.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The Synthes Navigable Pedicle Preparation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR. 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122211: Synthes Navigable Pedicle Preparation Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122211
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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