510(k) · Cleared
ClearedLigaPASS™ 2.0 Ligament Augmentation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea International SA · OWI Bone Fixation Cerclage, Sublaminar
Cleared on May 24, 2022 as substantially equivalent to K173506 (Medicrea International SA, 2018) and 2 other predicates after a 186-day review. Its family tree reaches back 10 generations to 1993. 2 later devices descend from it.
- Decided
- May 24, 2022
- Review
- 186 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K925812 (1993). 32 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 6 generations between
- 3 generations backK160698 LigaPASSMedicrea International SA · 2016
- 2 generations backK172021 LigaPASSMedicrea International SA · 2017
- 1 generation backK173506 LigaPASSMedicrea International SA · 2018
- This deviceK213659 LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA · 2022
- Descendant · cites it directly · 0 of its ownK253615 Invictus Bands SystemAlphatec Spine, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK230565 HILINE™ Fixation SystemGlobus Medical, Inc. · 2023
Show all 10 generations
- Root · 10 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 9 generations backK974020 Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997
- 8 generations backK060009 Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006
- 7 generations backK081622 Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
- 6 generations backK091190 Universal Clamp Stainless Steel System, Models SNA027-0-30060…Zimmer Spine, Inc. · 2009
- 5 generations backK110348 Universal Clamp Spinal Fixation SystemZimmer Spine · 2011
- 4 generations backK132395 LigapassMedicrea International · 2013
- 3 generations backK160698 LigaPASSMedicrea International SA · 2016
- 2 generations backK172021 LigaPASSMedicrea International SA · 2017
- 1 generation backK173506 LigaPASSMedicrea International SA · 2018
- This deviceK213659 LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA · 2022
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 |
|---|---|---|---|---|---|
| −10 | K925812 | Titanium Songer Cable System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −9 | K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | 1997 | — |
| −8 | K060009 | Abbott Spine Universal Clamp System | Abbott Spine, Inc. | 2006 | — |
| −7 | K081622 | Universal Clamp Stainless Steel System | Abbott Spine, Inc. | 2008 | — |
| −6 | K091190 | Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063 | Zimmer Spine, Inc. | 2009 | — |
| −5 | K110348 | Universal Clamp Spinal Fixation System | Zimmer Spine | 2011 | — |
| −4 | K132395 | Ligapass | Medicrea International | 2013 | — |
| −3 | K160698 | LigaPASS | Medicrea International SA | 2016 | — |
| −2 | K172021 | LigaPASS | Medicrea International SA | 2017 | — |
| −1 | K173506 | LigaPASS | Medicrea International SA | 2018 | — |
| 0 (this device) | K213659 | LigaPASS™ 2.0 Ligament Augmentation System | Medicrea International SA | 2022 | — |
| +1 | K253615 | Invictus Bands System | Alphatec Spine, Inc. | 2026 | — |
| +1 | K230565 | HILINE™ Fixation System | Globus Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 OWI? 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 OWI device
- #1 K253615 Invictus Bands Systemscore 20.7 · 33 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K173506 | LigaPASSSummary page 4…tion cerclage Class: II Product Code: OWI (21 CFR §888.3010) Primary Predicate: LigaPASS™ 2.0 Band and Dual Band (K173506) Additional Predicate: LigaPASS™ 2.0 Medial and Medial Open Connector (K172021), Pass L… | 2018 |
| * | K172021 | LigaPASSSummary page 4…te: LigaPASS™ 2.0 Band and Dual Band (K173506) Additional Predicate: LigaPASS™ 2.0 Medial and Medial Open Connector (K172021), Pass LP (K112736) Indications For Use: The LigaPASS™ system is an implant for use in orthopaedic surgery. The system is inten… | 2017 |
| * | K112736 | Pass LP SpinalSummary page 4…PASS™ 2.0 Band and Dual Band (K173506) Additional Predicate: LigaPASS™ 2.0 Medial and Medial Open Connector (K172021), Pass LP (K112736) Indications For Use: The LigaPASS™ system is an implant for use in orthopaedic surgery. The system is intended to provide temp… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 29 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 32 ancestors has a recall of any class.
- Of its descendants, K253615 (Alphatec Spine, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K173506.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OWI
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OWI
60in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWI
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWI
6in 2025
MAUDE reports naming product code OWI, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 92 | 0 | 1 |
| 2015 | 3 | 93 | 0 | 1 |
| 2016 | 5 | 98 | 0 | 6 |
| 2017 | 7 | 77 | 0 | 6 |
| 2018 | 4 | 156 | 0 | 2 |
| 2019 | 3 | 51 | 0 | 13 |
| 2020 | 3 | 60 | 1 | 8 |
| 2021 | 1 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The LigaPASS™ system is an implant for use in orthopaedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use are as follows: • Spinal trauma surgery, used in sublaminar or facet wiring techniques; • Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such…
Read the full statement (143 words)
The LigaPASS™ system is an implant for use in orthopaedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use are as follows:
• Spinal trauma surgery, used in sublaminar or facet wiring techniques;
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adults scoliosis and kyphosis;
• Spine degenerative surgery as an adjunct to spinal fusions.
• Intended for use with a posterior spinal instrumentation construct when ligament augmentation is needed.
The LigaPASS™ system may also be used in conjunction with other medical implants made of titanium or cobalt-chrome alloy whenever "wiring" may help secure the attachment of other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213659 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213659: LigaPASS™ 2.0 Ligament Augmentation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213659
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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