510(k) · Cleared
ClearedPass LP Spinal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea International · JDQ Cerclage, Fixation
Cleared on Feb 1, 2012 as substantially equivalent to K060009 (Abbott Spine, Inc., 2006) after a 134-day review. Its family tree reaches back 3 generations to 1993. 25 later devices descend from it.
- Decided
- Feb 1, 2012
- Review
- 134 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K925812 (1993). 25 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 2 generations backK974020 Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997
- 1 generation backK060009 Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006
- This deviceK112736 Pass LP SpinalMedicrea International · 2012
- Descendant · cites it directly · 23 of its ownK132395 LigapassMedicrea International · 2013
- Descendant · 2 generations on · 12 of its ownK160698 LigaPASSMedicrea International SA · 2016
- Descendant · 3 generations on · 11 of its ownK172021 LigaPASSMedicrea International SA · 2017
- Descendant · cites it directly · 11 of its ownK133482 Silc Fixation SystemGlobus Medical, Inc. · 2014
- Descendant · cites it directly · 10 of its ownK143350 Nile Alternative FixationK2m, Inc. · 2015
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K132395LigapassMedicrea International · 2013 · cites it directly23descendants
- K160698LigaPASSMedicrea International SA · 2016 · 2 generations on12descendants
- K172021LigaPASSMedicrea International SA · 2017 · 3 generations on11descendants
- K133482Silc Fixation SystemGlobus Medical, Inc. · 2014 · cites it directly11descendants
- K143350Nile Alternative FixationK2m, Inc. · 2015 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925812 | Titanium Songer Cable System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −2 | K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | 1997 | — |
| −1 | K060009 | Abbott Spine Universal Clamp System | Abbott Spine, Inc. | 2006 | — |
| 0 (this device) | K112736 | Pass LP Spinal | Medicrea International | 2012 | — |
| +1 | K132395 | Ligapass | Medicrea International | 2013 | — |
| +2 | K160698 | LigaPASS | Medicrea International SA | 2016 | — |
| +3 | K172021 | LigaPASS | Medicrea International SA | 2017 | — |
| +1 | K133482 | Silc Fixation System | Globus Medical, Inc. | 2014 | — |
| +1 | K143350 | Nile Alternative Fixation | K2m, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 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 JDQ? 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 JDQ device
- #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 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 |
|---|---|---|---|
| * | K060009 | Abbott Spine Universal Clamp SystemSummary page 1…Code JDQ CFR section 1888.3010 Device panel Orthopedic devices rkte reict Universal Clamp System (Abbott Spine)=K060009 Reason for Special 510(k) 1Additional components Submitter MEDICREA International… | 2006 |
What descends from it? (25)
See all 254 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 19 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K132395 (Medicrea International, 2013) has gone furthest, with 23 descendants of its own.
- 7 other devices also cite its predicate K060009.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JDQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDQ
130in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDQ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDQ
84in 2025
MAUDE reports naming product code JDQ, 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 | 1 | — | 0 | 5 |
| 2008 | 2 | — | 2 | 25 |
| 2009 | 2 | — | 0 | 19 |
| 2010 | 0 | — | 2 | 28 |
| 2011 | 6 | 130 | 0 | 30 |
| 2012 | 3 | 134 | 0 | 130 |
| 2013 | 1 | — | 1 | 321 |
| 2014 | 2 | — | 0 | 223 |
| 2015 | 5 | 92 | 1 | 205 |
| 2016 | 4 | 129 | 0 | 224 |
| 2017 | 1 | — | 0 | 138 |
| 2018 | 6 | 101 | 0 | 182 |
| 2019 | 0 | — | 5 | 158 |
| 2020 | 4 | 93 | 0 | 125 |
| 2021 | 0 | — | 0 | 141 |
| 2022 | 2 | — | 0 | 134 |
| 2023 | 3 | 141 | 0 | 98 |
| 2024 | 3 | 130 | 0 | 115 |
| 2025 | 2 | — | 0 | 84 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The LigaPASS is a temporary implant for use in orthopedic surgery on skeletally mature patients. 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, interspinous. or facet wiring techniques; *Spinal reconstructive surgery, incorporated into…
Read the full statement (118 words)
The LigaPASS is a temporary implant for use in orthopedic surgery on skeletally mature patients. 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, interspinous. or facet wiring techniques;
*Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, kyphosis, spondylolisthesis;
*Spinal degenerative surgery, as an adjunct to spinal fusions;
The LigaPASS 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/K112736 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112736: Pass LP Spinal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112736
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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