510(k) · Cleared
Recalled · Class II · 2025OTS Hip
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 Mar 11, 2024 as substantially equivalent to K181449 (Ortoma AB, 2018) after a 237-day review. Its family tree reaches back 9 generations to 1999. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 11, 2024
- Review
- 237 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K983831 (1999). 37 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations between
- 3 generations backK102990 Brainlab KneeBrainlab AG · 2011 · Recalled
- 2 generations backK122011 Navigation Software Hip-Universal; Navigation Software Hip…Brainlab AG · 2012 · Recalled
- 1 generation backK181449 Ortoma Treatment Solution - OTSOrtoma AB · 2018
- This deviceK232140 OTS HipOrtoma AB · 2024
- Descendant · cites it directly · 1 of its ownK250086 OTS HipOrtoma AB · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK261852 OTS HipOrtoma AB · 2026
Show all 9 generations
- Root · 9 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 8 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 7 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 6 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 5 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 4 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 3 generations backK102990 Brainlab KneeBrainlab AG · 2011 · Recalled
- 2 generations backK122011 Navigation Software Hip-Universal; Navigation Software Hip…Brainlab AG · 2012 · Recalled
- 1 generation backK181449 Ortoma Treatment Solution - OTSOrtoma AB · 2018
- This deviceK232140 OTS HipOrtoma AB · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −8 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −7 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −6 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −5 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −4 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −3 | K102990 | Brainlab Knee | Brainlab AG | 2011 | 1 |
| −2 | K122011 | Navigation Software Hip-Universal; Navigation Software Hip THR-Aesculap | Brainlab AG | 2012 | 1 |
| −1 | K181449 | Ortoma Treatment Solution - OTS | Ortoma AB | 2018 | — |
| 0 (this device) | K232140 | OTS Hip | Ortoma AB | 2024 | — |
| +1 | K250086 | OTS Hip | Ortoma AB | 2025 | 1 |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K181449 | Ortoma Treatment Solution - OTSSummary page 5…lassification Name: 21 CFR Section 882.4560, Stereotaxic Instrument Regulatory Class: II Product Code: OLO Predicate Devices Ortoma AB, Ortoma Treatment Solution system (K181449) Page 1 of 11.… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250086 | OTS Hip | 2025 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 28, 2025 | Class II | Z-2615-2025 | Process control | Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 37 ancestors have a recall of any class.
- Of its descendants, K250086 (Ortoma AB, 2025) has gone furthest, with 1 descendant 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. 2024, 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?
OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT medical imaging data of the patient anatomy. It is an intraoperative image-guided localization system that enables navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data being processed by the OTS platform. The system is indicated for orthopedic hip surgical…
Read the full statement (136 words)
OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT medical imaging data of the patient anatomy. It is an intraoperative image-guided localization system that enables navigated surgery. It links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data being processed by the OTS platform.
The system is indicated for orthopedic hip surgical procedures where a reference to a rigid anatomical structure, such as the pelvis, can be identified relative to a CT-based model of the anatomy. The system aids the surgeon to accurately navigate a compatible prosthesis to the preoperatively planned position.
The system is designed for orthopedic surgical procedures including:
- Pre-operative planning of Total Hip Arthroplasty (THA)
- Intraoperative navigated surgery for THA using a posterior approach
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232140 · printed Nov 3, 2026
Cite this page
510(k) Report. “K232140: OTS Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K232140
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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