510(k) · Cleared
ClearedResCUBE™ Ligament Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cousin Biotech Sas · OWI Bone Fixation Cerclage, Sublaminar
Cleared on Aug 29, 2018 as substantially equivalent to K172206 (Cousin Biotech Sas, 2018) and 3 other predicates after a 55-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Aug 29, 2018
- Review
- 55 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K925812 (1993). 30 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- 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 backK172206 NAJA™ Ligament Correction SystemCousin Biotech Sas · 2018
- This deviceK181799 ResCUBE™ Ligament Fixation SystemCousin Biotech Sas · 2018
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 | K172206 | NAJA™ Ligament Correction System | Cousin Biotech Sas | 2018 | — |
| 0 (this device) | K181799 | ResCUBE™ Ligament Fixation System | Cousin Biotech Sas | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 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 |
| 2016 | 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? (4)
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 |
|---|---|---|---|
| * | K172206 | NAJA™ Ligament Correction SystemSummary page 4…Fixation Cerclage, Sublaminar Classification 21 CFR §888.3010 – Bone Fixation Cerclage, Class II Regulation: Product Code: OWI Substantially K172206 – Cousin Biotech S.A.S. - NAJA™ Ligament Correction Equivalent Devices: System (Primary) K922952, K9412… | 2018 |
| * | K922952 | Songer Cable SystemSummary page 4…uct Code: OWI Substantially K172206 – Cousin Biotech S.A.S. - NAJA™ Ligament Correction Equivalent Devices: System (Primary) K922952, K941213 - Pioneer Surgical (now RTI Surgical) - Songer Spinal Cable (Additional Predicate)… | 1993 |
| * | K941213 | Songer Cable SystemSummary page 4…OWI Substantially K172206 – Cousin Biotech S.A.S. - NAJA™ Ligament Correction Equivalent Devices: System (Primary) K922952, K941213 - Pioneer Surgical (now RTI Surgical) - Songer Spinal Cable (Additional Predicate)… | 1994 |
| * | K153348 | Jazz LockSummary page 4…K922952, K941213 - Pioneer Surgical (now RTI Surgical) - Songer Spinal Cable (Additional Predicate) K153348 - Implanet S.A. - JAZZ LOCK (Additional Predicate) Device Description: The ResCUBE™ Ligament Fixation System (ResCUBE System)… | 2016 |
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 25 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 30 ancestors has a recall of any class.
- 1 other device also cites its predicate K172206.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 ResCUBE System 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:
1. Spinal trauma surgery, that can be treated with sublaminar, interspinous or facet wiring techniques.
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as
scoliosis, kyphosis and spondylolisthesis.
3. Spinal degenerative surgery, as an adjunct to spinal fusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181799 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181799: ResCUBE™ Ligament Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181799
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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