510(k) · Cleared
ClearedNavigation Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evergreen Orthopedic Research Lab · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 19, 2013 as substantially equivalent to K100599 (Orthosoft, Inc., 2010) after an 87-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jul 19, 2013
- Review
- 87 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002053 (2000). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 5 generations backK022364 Navitrack System Total Hip Replacement,Model 900.200Orthosoft, Inc. · 2003
- 4 generations backK030827 Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204Orthosoft, Inc. · 2003 · Recalled
- 3 generations backK032917 Navitrack System - Total Hip Replacement CT-FreeOrthosoft, Inc. · 2003
- 2 generations backK071929 Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc. · 2007 · Recalled
- 1 generation backK100599 Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80…Orthosoft, Inc. · 2010
- This deviceK131130 Navigation PinEvergreen Orthopedic Research Lab · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −5 | K022364 | Navitrack System Total Hip Replacement,Model 900.200 | Orthosoft, Inc. | 2003 | — |
| −4 | K030827 | Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204 | Orthosoft, Inc. | 2003 | 1 |
| −3 | K032917 | Navitrack System - Total Hip Replacement CT-Free | Orthosoft, Inc. | 2003 | — |
| −2 | K071929 | Navitrack System- Partial Hip Resurfacing Universal | Orthosoft, Inc. | 2007 | 3 |
| −1 | K100599 | Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR… | Orthosoft, Inc. | 2010 | — |
| 0 (this device) | K131130 | Navigation Pin | Evergreen Orthopedic Research Lab | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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.
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? (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 |
|---|---|---|---|
| * | K100599 | Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton…Summary page 1…UCT CODE: OLO PRODUCT CLASS: 11 SUBSTANTIALLY EQUIVALENT DEVICES: Zimmer CAS Fixation Pins (K 100599) DEVICE DESCRIPTION: The Navigation Pin is a partially threaded stainless steel (ASTM F1 38-08) pin with lengths of 10… | 2010 |
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 13 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 16 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. 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 Operativ Navigation Pin is indicated for use as temporary fixation pin to attach an orthopedic stereotaxic tracker holder to bone which allows the tracker to be referenced by the computer during a total knee arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131130: Navigation Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131130
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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