510(k) · Cleared
ClearedCas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton Pin 3.2 Dia X 150 MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthosoft, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Apr 5, 2010 as substantially equivalent to K071929 (Orthosoft, Inc., 2007) after a 33-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Apr 5, 2010
- Review
- 33 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002053 (2000). 15 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 4 generations backK022364 Navitrack System Total Hip Replacement,Model 900.200Orthosoft, Inc. · 2003
- 3 generations backK030827 Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204Orthosoft, Inc. · 2003 · Recalled
- 2 generations backK032917 Navitrack System - Total Hip Replacement CT-FreeOrthosoft, Inc. · 2003
- 1 generation backK071929 Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc. · 2007 · Recalled
- This deviceK100599 Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80…Orthosoft, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK131130 Navigation PinEvergreen Orthopedic Research Lab · 2013
Most influential descendants
Showing 1 of 1 · See all- K131130Navigation PinEvergreen Orthopedic Research Lab · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −4 | K022364 | Navitrack System Total Hip Replacement,Model 900.200 | Orthosoft, Inc. | 2003 | — |
| −3 | K030827 | Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204 | Orthosoft, Inc. | 2003 | 1 |
| −2 | K032917 | Navitrack System - Total Hip Replacement CT-Free | Orthosoft, Inc. | 2003 | — |
| −1 | K071929 | Navitrack System- Partial Hip Resurfacing Universal | Orthosoft, Inc. | 2007 | 3 |
| 0 (this device) | K100599 | Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR… | Orthosoft, Inc. | 2010 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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 |
|---|---|---|---|
| * | K071929 | Navitrack System- Partial Hip Resurfacing UniversalSummary page 1…trument (84 HAW); 21 CFR § 882.4560 Predicate Device: Navitrack® System - Partial Hip Resurfacing Universal from Zimmer GAS (transferred from Orthosoft Inc.), 5 10(k) # K071929 Device Description: GAS Fixation Pins are threaded bone pins similar to Steinmann pins. They are used to temporarily fixate loca… | 2007 |
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 |
|---|---|---|---|
| K131130 | Navigation Pin | 2013 | 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 10 years and passes through 1 company; a new generation was cleared every 2.5 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K131130 (Evergreen Orthopedic Research Lab, 2013) 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. 2010, 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?
CAS Fixation Pins from Zimmer CAS are intended for use as temporary bone fixation pins to attach orthopedic surgical instruments to bones in order to allow referencing their relative locations as required in the use of computer assisted surgery systems. Their specific uses and indications including their method of use and attachment sites are as specified in the computer assisted surgery system that involves their use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100599: Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton Pin 3.2 Dia X 150 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100599
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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