510(k) · Cleared
ClearedStealth™ Spine Clamps; ModuLeX™ Shank Mounts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Jun 5, 2025 as substantially equivalent to K211442 (Medtronic Navigation, 2021) and 1 other predicate after a 290-day review. Its family tree reaches back 14 generations to 1984. 1 later device descends from it.
- Decided
- Jun 5, 2025
- Review
- 290 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K841189 (1984). 95 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK112405 Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 2 generations backK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
- 1 generation backK211442 StealthStation Spinous Process ClampsMedtronic Navigation · 2021
- This deviceK242464 Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK254165 Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 4 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 3 generations backK112405 Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 2 generations backK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
- 1 generation backK211442 StealthStation Spinous Process ClampsMedtronic Navigation · 2021
- This deviceK242464 Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −4 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −3 | K112405 | Clydesdales Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −2 | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter | Medtronic Navigation, Inc. | 2013 | 10 |
| −1 | K211442 | StealthStation Spinous Process Clamps | Medtronic Navigation | 2021 | — |
| 0 (this device) | K242464 | Stealth™ Spine Clamps; ModuLeX™ Shank Mounts | Medtronic Navigation, Inc. | 2025 | — |
| +1 | K254165 | Infinity™ OCT System | Medtronic Sofamor Danek USA, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2008 | 4 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 OLO? 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? (2)
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 |
|---|---|---|---|
| * | K211442 | StealthStation Spinous Process ClampsSummary page 5…Subject Device Predicate Device Stealth™ Spine Clamps StealthStation™ Spinous Process Clamps K211442 S.E. July 8, 2021 ModuLeX™ Shank Mounts Rod Clamps cleared as an accessor… | 2021 |
| * | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterSummary page 5…CAPSTONE® Trials, CLYDESDALE® Trials, and CAPSTONE® & CLYDESDALE® Inserter K131425 S.E. August 14, 2013 K242464 -… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254165 | Infinity™ OCT System | 2026 | 0 |
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 41 years and passes through 11 companies; a new generation was cleared every 1.7 years on median.
- 14 of the 95 ancestors have a recall of any class.
- Of its descendants, K254165 (Medtronic Sofamor Danek USA, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Stealth™ Spine Clamps When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable: • The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. • The navigated instruments are specifically designed for use with Medtronic computer-assisted…
Read the full statement (253 words)
Stealth™ Spine Clamps
When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:
• The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
• The navigated instruments are specifically designed for use with Medtronic computer-assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
• The Stealth™ spine clamps are indicated for skeletally mature patients.
ModuLeX™ Shank Mounts
When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:
• The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
• The navigated instruments are specifically designed for use with Medtronic computer-assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
• The ModuLeX™ shank mounts are indicated to be used with the CD Horizon™ ModuLeX™ Spinal System during surgery.
• The ModuLeX™ shank mounts are indicated for skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242464: Stealth™ Spine Clamps; ModuLeX™ Shank Mounts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242464
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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