# K023564: Osse-Lign

- Pathway: 510(k) (Traditional)
- Applicant: Osseus, LLC
- Decided: Mar 11, 2003 after 139 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
Longest line of descent: 4 generations back to K844068 (1985). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982545: BMP Cable System, Biomet, Inc. (1998) Summary page 5.
- K971741: Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable, Howmedica Corp. (1997)
- K961569: Dall-Miles Stainless Steel Beaded Cable, Howmedica Corp. (1996) Summary page 5.
- K992616: SDB Cerclage System, Pioneer Surgical Technology (1999) Summary page 5.
- (no number) Stainless Steel Cerclage Wire manufactured prior to 1976: named in the summary without a submission 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 Trocanterk reattachment Fixation of fractures in conjunction with I/M nailing and plating techniques Stabilization of cortical onlay strut graft Temporary reduction techniques for OFUF (Open Reduction Internal Fixation)

Source page: https://510kreport.com/device/K023564
Methodology: https://510kreport.com/methodology