510(k) · Cleared
ClearedOsse-Lign, 1.5MM Cocr and SS Cable System and Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osseus, LLC · JDQ Cerclage, Fixation
Cleared on Feb 20, 2004 after a 22-day review. The FDA summary names no predicate by number.
- Decided
- Feb 20, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Osse-Lign System is indicated for general orthopedic repairs. This includes such procedures as long bone fractures, bone grafting and reinforcement of bone. This system may also be used for supplementary fixation and reduction with approved bone plates, screws, pins, nails and bone grafting material. Long Bone Fractures • Femur fractures • Tibia fractures • Humerus fractures Joint Fractures • Ankle fractures • Knee Fractures • Hip Fractures •…
Read the full statement (120 words)
The Osse-Lign System is indicated for general orthopedic repairs. This includes such procedures as long bone fractures, bone grafting and reinforcement of bone. This system may also be used for supplementary fixation and reduction with approved bone plates, screws, pins, nails and bone grafting material.
Long Bone Fractures
• Femur fractures
• Tibia fractures
• Humerus fractures
Joint Fractures
• Ankle fractures
• Knee Fractures
• Hip Fractures
• Shoulder Fractures
• Elbow Fractures
Other bone fractures
• Olecranon
• Pelvis fractures
• Patella fractures
• Acetabular fractures
• Trocanteric reattachment
* Fixation of fractures in conjunction with I/M nailing and plating techniques
* Stabilization of cortical onlay strut graft
• Temporary reduction techniques for ORIF (Open Reduction Internal Fixation)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040199 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040199: Osse-Lign, 1.5MM Cocr and SS Cable System and Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040199
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026