510(k) · Cleared
ClearedGYDER® Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyder Surgical Pty, Ltd. · OLO Orthopedic Stereotaxic Instrument
Cleared on Jan 29, 2025 as substantially equivalent to K130387 (Orthalign, Inc., 2013) after a 90-day review. Its family tree reaches back 10 generations to 1999. 1 later device descends from it.
- Decided
- Jan 29, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K983831 (1999). 24 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 6 generations between
- 3 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 2 generations backK103829 Kneealign SystemOrthalign, Inc. · 2011
- 1 generation backK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- This deviceK243387 GYDER® Hip SystemGyder Surgical Pty, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK253507 Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack…Orthalign, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 9 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 8 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 7 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 6 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 5 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 4 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 3 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 2 generations backK103829 Kneealign SystemOrthalign, Inc. · 2011
- 1 generation backK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- This deviceK243387 GYDER® Hip SystemGyder Surgical Pty, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −9 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −8 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −7 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −6 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −5 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −4 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| −3 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| −2 | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| −1 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| 0 (this device) | K243387 | GYDER® Hip System | Gyder Surgical Pty, Ltd. | 2025 | — |
| +1 | K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | Orthalign, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K130387 | Orthoalign Plus SystemSummary page 5…nt Classification: Class II Product Code: OLO Submission Type: Traditional 510(k), New Device Regulation Number: 21 CFR 882.4560 Predicate Device: OrthAlign Plus System (K130387) Indications For Use The GYDER® Hip Navigation System is a computer-controlled system intended to assist the surgeon in deter… | 2013 |
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 |
|---|---|---|---|
| K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | 2026 | 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 26 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 24 ancestors have a recall of any class.
- Of its descendants, K253507 (Orthalign, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130387.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 GYDER® Hip Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopaedic surgical procedures. The GYDER® Hip Navigation System facilitates the accurate positioning of the acetabular cup only during Anterior Hip Arthroplasty approaches with the patients in supine position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243387: GYDER® Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243387
Report an extraction error
Are you the manufacturer?
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