510(k) · Cleared
ClearedOrtoma Treatment Solution - OTS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortoma AB · OLO Orthopedic Stereotaxic Instrument
Cleared on Sep 19, 2018 as substantially equivalent to K122011 (Brainlab AG, 2012) after a 110-day review. Its family tree reaches back 8 generations to 1999. 3 later devices descend from it.
- Decided
- Sep 19, 2018
- Review
- 110 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K983831 (1999). 36 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 7 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 6 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 5 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 4 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 3 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 2 generations backK102990 Brainlab KneeBrainlab AG · 2011 · Recalled
- 1 generation backK122011 Navigation Software Hip-Universal; Navigation Software Hip…Brainlab AG · 2012 · Recalled
- This deviceK181449 Ortoma Treatment Solution - OTSOrtoma AB · 2018
- Descendant · cites it directly · 2 of its ownK232140 OTS HipOrtoma AB · 2024 · Recalled
- Descendant · 2 generations on · 1 of its ownK250086 OTS HipOrtoma AB · 2025 · Recalled
- Descendant · 3 generations on · 0 of its ownK261852 OTS HipOrtoma AB · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −7 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −6 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −5 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −4 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −3 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −2 | K102990 | Brainlab Knee | Brainlab AG | 2011 | 1 |
| −1 | K122011 | Navigation Software Hip-Universal; Navigation Software Hip THR-Aesculap | Brainlab AG | 2012 | 1 |
| 0 (this device) | K181449 | Ortoma Treatment Solution - OTS | Ortoma AB | 2018 | — |
| +1 | K232140 | OTS Hip | Ortoma AB | 2024 | 1 |
| +2 | K250086 | OTS Hip | Ortoma AB | 2025 | 1 |
| +3 | K261852 | OTS Hip | Ortoma AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K122011 | Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapSummary page 4…redicate Device(s): Manufacturer Device Name 510(k) Number Procode Class Brainlab AG Brainlab Hip K122011 OLO II Indications for Use The Ortoma Treatment Solution system is intended to be an intraoperative image-guided loca… | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232140 | OTS Hip | 2024 | 2 |
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 19 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 36 ancestors have a recall of any class.
- Of its descendants, K232140 (Ortoma AB, 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K122011.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Ortoma Treatment Solution system is intended to be an intraoperative image-guided localization system to enable navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space either on a patient's preoperative image data being processed by OTS platform, or on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is…
Read the full statement (166 words)
The Ortoma Treatment Solution system is intended to be an intraoperative image-guided localization system to enable navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space either on a patient's preoperative image data being processed by OTS platform, or on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface.
The system is indicated for hip surgical procedures, in which the use of navigated surgery is considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT-based model of the anatomy. The system aids the surgeon to accurately navigate a hip prosthesis to the preoperatively planned position.
Example orthopedic surgical procedures include but are not limited to:
Total Hip Arthroplasty (THA) using posterior approach.
Preoperative planning and intraoperative navigated surgery for joint replacement with Stryker Exeter X3 Rimfit cups.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181449: Ortoma Treatment Solution - OTS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181449
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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