510(k) · Cleared
ClearedVIPER PRIME navigated inserter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · OLO Orthopedic Stereotaxic Instrument
Cleared on Sep 14, 2017 as substantially equivalent to K122211 (Synthes Spine, 2012) after a 168-day review. Its family tree reaches back 6 generations to 1999. 1 of the 20 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Sep 14, 2017
- Review
- 168 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K983831 (1999). 13 ancestors in all, the oldest K981508 (1998). 6 later devices descend from it, 2 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 4 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 3 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 2 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 1 generation backK122211 Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine · 2012
- This deviceK170937 VIPER PRIME navigated inserterMedos International SARL · 2017
- Descendant · cites it directly · 4 of its ownK231280 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2023
- Descendant · 2 generations on · 3 of its ownK233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2024
- Descendant · 2 generations on · 2 of its ownK240846 CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK233793 CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK243106 CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3D2 generations back · 2007
Most influential descendants
Showing 5 of 6 · See all- K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd. · 2023 · cites it directly4descendants
- K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2024 · 2 generations on3descendants
- K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd. · 2024 · 2 generations on2descendants
- K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024 · 2 generations on1descendant
- K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −5 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −4 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −3 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −2 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −1 | K122211 | Synthes Navigable Pedicle Preparation Instruments | Synthes Spine | 2012 | — |
| 0 (this device) | K170937 | VIPER PRIME navigated inserter | Medos International SARL | 2017 | — |
| +1 | K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments… | CarboFix Orthopedics, Ltd. | 2023 | — |
| +2 | K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | CarboFix Orthopedics, Ltd. | 2024 | — |
| +2 | K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated… | CarboFix Orthopedics, Ltd. | 2024 | — |
| +2 | K233793 | CarboClear® X Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
| +3 | K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K122211 | Synthes Navigable Pedicle Preparation InstrumentsSummary page 4…de: OLO; Orthopedic D. Predicate Device Name Primary Predicate Device: Synthes Navigable Pedicle Preparation Instruments (K122211) Reference Devices: Stryker SpineMap® 3D Navigation System (K141941) Medtronic StealthStation® System (K133444… | 2012 |
| † | K141941 | Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D… | 2014 |
| † | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | 2014 |
| † | K070106 | VV Fluoro 3D | 2007 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 4 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K231280 (CarboFix Orthopedics, Ltd., 2023) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K122211.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The VIPER PRIME navigated inserter is a navigated instrument for insertion of VIPER PRIME screws in open or percutaneous procedures. The VIPER PRIME navigated inserter is indicated for use in spinal surgical procedures, in which: • use of the VIPER System is indicated, • use of stereotactic surgery may be appropriate, and • where reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image…
Read the full statement (126 words)
The VIPER PRIME navigated inserter is a navigated instrument for insertion of VIPER PRIME screws in open or percutaneous procedures. The VIPER PRIME navigated inserter is indicated for use in spinal surgical procedures, in which:
• use of the VIPER System is indicated,
• use of stereotactic surgery may be appropriate, and
• where reference to a rigid anatomical structure, such as the pelvis or a vertebrae 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 using a navigation system which includes universal tracking arrays supplied by the navigation manufacturer.
These procedures include but are not limited to spinal fusion. The VIPER PRIME navigated inserter requires manual calibration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170937 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170937: VIPER PRIME navigated inserter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170937
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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