510(k) · Cleared
ClearedLigaPASS
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 Sep 2, 2016 as substantially equivalent to K132395 (Medicrea International, 2013) and 1 other predicate after a 172-day review. Its family tree reaches back 7 generations to 1993. 12 later devices descend from it.
- Decided
- Sep 2, 2016
- Review
- 172 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K925812 (1993). 29 ancestors in all, the oldest K781443 (1978). 12 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 6 generations backK974020 Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997
- 5 generations backK060009 Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006
- 4 generations backK081622 Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
- 3 generations backK091190 Universal Clamp Stainless Steel System, Models SNA027-0-30060…Zimmer Spine, Inc. · 2009
- 2 generations backK110348 Universal Clamp Spinal Fixation SystemZimmer Spine · 2011
- 1 generation backK132395 LigapassMedicrea International · 2013
- This deviceK160698 LigaPASSMedicrea International SA · 2016
- Descendant · cites it directly · 11 of its ownK172021 LigaPASSMedicrea International SA · 2017
- Descendant · 2 generations on · 9 of its ownK173506 LigaPASSMedicrea International SA · 2018
- Descendant · 3 generations on · 3 of its ownK222097 OLYMPIC Deformity Band SystemAstura Medical · 2023
- Descendant · 4 generations on · 2 of its ownK231694 MASADA Modular Spinal Fixation SystemAstura Medical · 2023
- Descendant · 2 generations on · 2 of its ownK213659 LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K172021LigaPASSMedicrea International SA · 2017 · cites it directly11descendants
- K173506LigaPASSMedicrea International SA · 2018 · 2 generations on9descendants
- K222097OLYMPIC Deformity Band SystemAstura Medical · 2023 · 3 generations on3descendants
- K231694MASADA Modular Spinal Fixation SystemAstura Medical · 2023 · 4 generations on2descendants
- K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K925812 | Titanium Songer Cable System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −6 | K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | 1997 | — |
| −5 | K060009 | Abbott Spine Universal Clamp System | Abbott Spine, Inc. | 2006 | — |
| −4 | K081622 | Universal Clamp Stainless Steel System | Abbott Spine, Inc. | 2008 | — |
| −3 | K091190 | Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063 | Zimmer Spine, Inc. | 2009 | — |
| −2 | K110348 | Universal Clamp Spinal Fixation System | Zimmer Spine | 2011 | — |
| −1 | K132395 | Ligapass | Medicrea International | 2013 | — |
| 0 (this device) | K160698 | LigaPASS | Medicrea International SA | 2016 | — |
| +1 | K172021 | LigaPASS | Medicrea International SA | 2017 | — |
| +2 | K173506 | LigaPASS | Medicrea International SA | 2018 | — |
| +3 | K222097 | OLYMPIC Deformity Band System | Astura Medical | 2023 | — |
| +4 | K231694 | MASADA Modular Spinal Fixation System | Astura Medical | 2023 | — |
| +2 | K213659 | LigaPASS™ 2.0 Ligament Augmentation System | Medicrea International SA | 2022 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K132395 | LigapassSummary page 4…e: Bone Fixation Cerclage, Sublaminar Classification Name: ϴϴϴ͘ϯϬϭϬͲBone Fixation Cerclage Regulatory Class: II Product Code: OWI PREDICATE DEVICES Medicrea LigaPass, K132395. Zimmer Spine Universal Clamp, K142053 (primary). DEVICE DESCRIPTION The LigaPASS System connects a rod to a vertebral body usi… | 2013 |
| * | K142053 | Universal Clamp Spinal Fixation SystemSummary page 4…lassification Name: ϴϴϴ͘ϯϬϭϬͲBone Fixation Cerclage Regulatory Class: II Product Code: OWI PREDICATE DEVICES Medicrea LigaPass, K132395. Zimmer Spine Universal Clamp, K142053 (primary). DEVICE DESCRIPTION The LigaPASS System connects a rod to a vertebral body using a specific type of connector and a f… | 2014 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172021 | LigaPASS | 2017 | 11 |
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 23 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 29 ancestors has a recall of any class.
- Of its descendants, K172021 (Medicrea International SA, 2017) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K132395.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 is a temporary implant for use in orthopedic 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 include the following applications: - Spinal trauma surgery, used in sublaminar, or facet wiring techniques; - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of…
Read the full statement (132 words)
The LigaPASS is a temporary implant for use in orthopedic 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 include the following applications:
- 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, adult scoliosis, and kyphosis;
- Spinal degenerative surgery, as an adjunct to spinal fusions;
The LigaPASS system may also be used in conjunction with other medical implant grade implants made of titanium or cobalt chrome alloy whenever “wiring” may help secure the attachment of other implants.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160698: LigaPASS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160698
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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