510(k) · Cleared
ClearedHIP7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · OLO Orthopedic Stereotaxic Instrument
Cleared on Jun 2, 2020 as substantially equivalent to K122011 (Brainlab AG, 2012) after a 186-day review. Its family tree reaches back 8 generations to 1999.
- Decided
- Jun 2, 2020
- Review
- 186 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. No later device cites it as a predicate yet.
- 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 deviceK193307 HIP7Brainlab AG · 2020
View 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) | K193307 | HIP7 | Brainlab AG | 2020 | — |
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 |
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…mmon Name: Stereotaxic Instrument Regulatory Class: Class II Regulation: 21 CFR 882.4560 Product Codes: OLO Predicate Device(s): K122011 Brainlab Hip Device Description: The HIP7 system is intended to enable navigation in orthopedic hip replacement surgery. It links… | 2012 |
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 21 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- 5 of the 36 ancestors have a recall of any class.
- 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. 2020, 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?
HIP7 is intended to be an intraoperative image-guided localization system to enable minimally invasive 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 Brainlab IGS platforms, 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…
Read the full statement (166 words)
HIP7 is intended to be an intraoperative image-guided localization system to enable minimally invasive 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 Brainlab IGS platforms, 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 any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as a long bone or vertebra, can be identified relative to a CT, X-Ray, or MR-based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprosthesis to the preoperatively or intraoperatively planned position.
Example orthopedic surgical procedures for the Computer Assisted Total Hip Replacement – HIP7 use case include but are not limited to:
• Total Joint Replacement
• Minimally invasive orthopedic surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193307: HIP7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193307
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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