510(k) · Cleared
ClearedSmith & Nephew SURESHOT Distal Targeting System V4.0
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 Apr 28, 2017 as substantially equivalent to K130748 (Smith & Nephew, Inc., 2013) and 4 other predicates after an 88-day review. Its family tree reaches back 13 generations to 2001.
- Decided
- Apr 28, 2017
- Review
- 88 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K010612 (2001). 48 ancestors in all, the oldest K933787 (1994). No later device cites it as a predicate yet.
- Root · 13 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 9 generations between
- 3 generations backK102967 Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc. · 2010
- 2 generations backK110240 Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc. · 2011
- 1 generation backK130748 Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc. · 2013
- This deviceK170280 Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc. · 2017
Show all 13 generations
- Root · 13 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 12 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 11 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 10 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 9 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 8 generations backK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- 7 generations backK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
- 6 generations backK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- 5 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- 4 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 3 generations backK102967 Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc. · 2010
- 2 generations backK110240 Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc. · 2011
- 1 generation backK130748 Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc. · 2013
- This deviceK170280 Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −12 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −11 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −10 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −9 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −8 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| −7 | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
| −6 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| −5 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| −4 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
| −3 | K102967 | Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2 | Smith & Newphew, Inc. | 2010 | — |
| −2 | K110240 | Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1 | Smith & Nephew, Inc. | 2011 | — |
| −1 | K130748 | Smith & Nephew Sureshot Distal Targeting System V3.0 | Smith & Nephew, Inc. | 2013 | — |
| 0 (this device) | 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 |
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? (5)
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 |
|---|---|---|---|
| * | K130748 | Smith & Nephew Sureshot Distal Targeting System V3.0Summary page 5…the below table with regard to intended use, indications for use, and performance characteristics. The subject devices feature characteristics as previously cleared in K130748 with the primary differences being additional software features which include the ability to target for the TRIGEN META-TAN Nail… | 2013 |
| * | K110240 | Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Summary page 6…2013 System V.3.0 Smith & Nephew Smith & SURESHOT™ Distal Targeting K110240 April 4, 2011 Nephew system V.2.1 Smith & Nephew Smith &… | 2011 |
| * | K102967 | Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Summary page 6…1 Smith & Nephew Smith & November 4, SURESHOT™ Distal Targeting K102967 Nephew 2010 System V.2.0.2… | 2010 |
| * | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0Summary page 6…Smith & Nephew Smith & February 23, SURESHOT™ Distal Targeting K100107 Nephew 2010 System V.2.0 Smith &… | 2010 |
| * | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Summary page 6…10 System V.2.0 Smith & Smith & Nephew PiGalileo September K092497 Nephew Screw Targeting System V1.1 11, 2009… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 14 of the 48 ancestors have a recall of any class.
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 Smith & Nephew SURESHOT™ Targeting System is intended to be an intraoperative image guided localization system. It is a computer assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary 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 bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170280: Smith & Nephew SURESHOT Distal Targeting System V4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170280
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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