510(k) · Cleared
ClearedLigapass
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea International · OWI Bone Fixation Cerclage, Sublaminar
Cleared on Dec 6, 2013 as substantially equivalent to K110348 (Zimmer Spine, 2011) and 1 other predicate after a 127-day review. Its family tree reaches back 6 generations to 1993. 23 later devices descend from it.
- Decided
- Dec 6, 2013
- Review
- 127 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K925812 (1993). 27 ancestors in all, the oldest K781443 (1978). 23 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 5 generations backK974020 Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997
- 4 generations backK060009 Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006
- 3 generations backK081622 Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
- 2 generations backK091190 Universal Clamp Stainless Steel System, Models SNA027-0-30060…Zimmer Spine, Inc. · 2009
- 1 generation backK110348 Universal Clamp Spinal Fixation SystemZimmer Spine · 2011
- This deviceK132395 LigapassMedicrea International · 2013
- Descendant · cites it directly · 12 of its ownK160698 LigaPASSMedicrea International SA · 2016
- Descendant · 2 generations on · 11 of its ownK172021 LigaPASSMedicrea International SA · 2017
- Descendant · cites it directly · 10 of its ownK143350 Nile Alternative FixationK2m, Inc. · 2015
- Descendant · 3 generations on · 9 of its ownK173506 LigaPASSMedicrea International SA · 2018
- Descendant · 2 generations on · 5 of its ownK161332 NILE Proximal Fixation Spinal SystemK2m, Inc. · 2017
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K160698LigaPASSMedicrea International SA · 2016 · cites it directly12descendants
- K172021LigaPASSMedicrea International SA · 2017 · 2 generations on11descendants
- K143350Nile Alternative FixationK2m, Inc. · 2015 · cites it directly10descendants
- K173506LigaPASSMedicrea International SA · 2018 · 3 generations on9descendants
- K161332NILE Proximal Fixation Spinal SystemK2m, Inc. · 2017 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K925812 | Titanium Songer Cable System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −5 | K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | 1997 | — |
| −4 | K060009 | Abbott Spine Universal Clamp System | Abbott Spine, Inc. | 2006 | — |
| −3 | K081622 | Universal Clamp Stainless Steel System | Abbott Spine, Inc. | 2008 | — |
| −2 | K091190 | Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063 | Zimmer Spine, Inc. | 2009 | — |
| −1 | K110348 | Universal Clamp Spinal Fixation System | Zimmer Spine | 2011 | — |
| 0 (this device) | K132395 | Ligapass | Medicrea International | 2013 | — |
| +1 | K160698 | LigaPASS | Medicrea International SA | 2016 | — |
| +2 | K172021 | LigaPASS | Medicrea International SA | 2017 | — |
| +1 | K143350 | Nile Alternative Fixation | K2m, Inc. | 2015 | — |
| +3 | K173506 | LigaPASS | Medicrea International SA | 2018 | — |
| +2 | K161332 | NILE Proximal Fixation Spinal System | K2m, Inc. | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K110348 | Universal Clamp Spinal Fixation SystemSummary page 1…owl CFR section 888.3010 Device panel Orthopedic Legally marketed predicate Universal Clamp Spinal Fixation System (Zimmer Spine)= K110348 devices LigaPASS (MEDICREA INTERNATIONAL) K 1112736 Submitter IMEDICREA International… | 2011 |
| * | K112736 | Pass LP SpinalSummary page 1…3(0)4 72 0187 87 ____________________ I-mail : [email protected] 2. PREDICATE DEVICE DESCRIPTION The Universal Clamp System (K110348) and LigaPASS (K112736) are temporary orthopedic implants intended to provide stabilization during the development of solid bony fusion and aid in the r… | 2012 |
What descends from it? (23)
See all 232 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 20 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K160698 (Medicrea International SA, 2016) has gone furthest, with 12 descendants of its own.
- 8 other devices also cite its predicate K110348.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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. LigaPASS system is indicated for 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 10 years of age and older, adult scoliosis, and kyphosis;
-Spinal degenerative surgery, as an adjunct to spinal fusions;
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132395: Ligapass.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132395
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