# K980594: Osteonics FX-Cablelok Grip Components

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: May 5, 1998 after 77 days
- Product code: LYT (Fixation Accessory)
- 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Howmedica Dall Miles Cable Grip System and Mini Cleat: named in the summary without a submission number
- (no number) FX-Cablelok System: named in the summary without a submission number

## Most influential descendants
- K984432: Dall-Miles Cable Grip (a-Grip) (1999), 2 descendants of its own
- K043252: Cabling System Trochanter Hook (2005), 1 descendant of its own
- K123598: Smith & Nephew, Inc. Hip System Instrumentation (2013), 0 descendants of its own

## Indications for use
The Osteonics® FX-Cablelok™ Grip Components are indicated for trochanteric reattachment and are intended for use with the commercially available Osteonics® FX-Cablelok™ System cable and sleeve components to provide fixation of the greater trochanter secondary to osteotomy in total hip replacement arthroplasty, surface replacement arthroplasty or any hip procedure requiring a trochanteric osteotomy.

Source page: https://510kreport.com/device/K980594
Methodology: https://510kreport.com/methodology