# K171911: Medline ReNewal Reprocessed Synthes External Fixation Systems

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Service and Savings, Inc.
- Decided: Nov 9, 2017 after 136 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K914558 (1992). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122455: Synthes Small External Fixation System, Synthes Large External Fixation System, Synthes (2013) Summary page 5.
- K090658: Synthes External Fixation Devices, MR Conditional, Synthes (Usa) (2010) Summary page 5.
- K092190: Synthes Distraction Osteogenesis System, MR Conditional with Expanded Indications, Synthes (Usa) (2010) Summary page 5.

## Indications for use
Medline Renewal Reprocessed Synthes Small External Fixation System is intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle. Specifically, the components can be used for: • Preliminary fixation before ORIF • Unstable fractures of the distal radius (both intra- and extra-articular) • Open and/or comminuted bilateral fractures • Fractures in combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement • Fracture dislocations • Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations) • Pediatric open fractures with bone loss and osteotomies The Medline ReNewal Reprocessed Synthes Medium External Fixation System, MR Conditional is intended for the construction of an external fixation frame for the treatment of pediatric and adult fractures. Medline ReNewal Reprocessed Synthes Large External Fixation System is intended to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: • Stabilization of soft tissues and fractures • Polytrauma/multiple orthopedic trauma • Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures • Arthrodeses and osteotomies with soft tissue problems; failures of total joints • Neutralization of fractures stabilized with limited internal fixation • Non-unions/septic non-unions • Intra-operative reductions/stabilization tool to assist with indirect reduction; • Unilateral rectilinear bone segment transport or leg lengthening. The Medline ReNewal Reprocessed Synthes Distraction Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.

Source page: https://510kreport.com/device/K171911
Methodology: https://510kreport.com/methodology