# K040199: Osse-Lign, 1.5MM Cocr and SS Cable System and Components

- Pathway: 510(k) (Special)
- Applicant: Osseus, LLC
- Decided: Feb 20, 2004 after 22 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
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)

Source page: https://510kreport.com/device/K040199
Methodology: https://510kreport.com/methodology