510(k) · Cleared
ClearedSmith & Nephew Sureshot Distal Targeting System V3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Aug 4, 2013 as substantially equivalent to K092497 (Smith & Nephew, Inc., 2009) and 3 other predicates after a 138-day review. Its family tree reaches back 12 generations to 2001. 1 later device descends from it.
- Decided
- Aug 4, 2013
- Review
- 138 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K010612 (2001). 47 ancestors in all, the oldest K933787 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 8 generations between
- 3 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 2 generations backK102967 Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc. · 2010
- 1 generation backK110240 Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc. · 2011
- This deviceK130748 Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK170280 Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc. · 2017
Show all 12 generations
- Root · 12 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 11 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 10 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 9 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 8 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 7 generations backK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- 6 generations backK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
- 5 generations backK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- 4 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- 3 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 2 generations backK102967 Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc. · 2010
- 1 generation backK110240 Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc. · 2011
- This deviceK130748 Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −11 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −10 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −9 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −8 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −7 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| −6 | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
| −5 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| −4 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
| −2 | K102967 | Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2 | Smith & Newphew, Inc. | 2010 | — |
| −1 | K110240 | Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1 | Smith & Nephew, Inc. | 2011 | — |
| 0 (this device) | K130748 | Smith & Nephew Sureshot Distal Targeting System V3.0 | Smith & Nephew, Inc. | 2013 | — |
| +1 | K170280 | Smith & Nephew SURESHOT Distal Targeting System V4.0 | Smith & Nephew, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (4)
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 |
|---|---|---|---|
| * | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Summary page 2…earance Mauacue Dsrito Number Date Smt ehw Smith & Nephew PiGalileo Screw K092497 09/I11/09 Smit & Nphew Targeting System VI1. I Smith & Nephew Smith & Nephew SURESHOT T… | 2009 |
| * | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0Summary page 2…K092497 09/I11/09 Smit & Nphew Targeting System VI1. I Smith & Nephew Smith & Nephew SURESHOT T " K100107 02/23/10 Distal Targeting System v.2.0 ________ _______ Smith & Nephew… | 2010 |
| * | K102967 | Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Summary page 2…2/23/10 Distal Targeting System v.2.0 ________ _______ Smith & Nephew Smith & Nephew SURESI-OT T " K102967 I11/04/10 Distal Targeting System v.2.0.2 ________ _______ Smith & Neph… | 2010 |
| * | K110240 | Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1 | 2011 |
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 |
|---|---|---|---|
| K170280 | Smith & Nephew SURESHOT Distal Targeting System V4.0 | 2017 | 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 12 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 14 of the 47 ancestors have a recall of any class.
- Of its descendants, K170280 (Smith & Nephew, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K092497.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Smith & Nephew SURESHOT Targeting System is intended to be an intreoperative image guided localization system. It is a computer assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedlullary nail implantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing Intraoperatively obtained electromagnetic tracking data. The Smith & Nephew SURESHOT Targeting System is indicated for long bane fractures treated with intramedullary nails in which the use of stereatactic surgery may be appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130748 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130748: Smith & Nephew Sureshot Distal Targeting System V3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130748
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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