# K971682: J-FX Cerclage System

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Jun 27, 1997 after 52 days
- Product code: LRN (Wire, Surgical)
- 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: 1 generation back to K921480 (1992). 3 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921480: Osteo-Clage (TM) Cerciage Cable System, Acu-Med, Inc. (1992) Summary page 1.
- K934058: Dall Miles System Minicleat, Howmedica Corp. (1994) Summary page 1.
- K935646: FX-Cablelok (TM) Stop (Trochanter Hook) System, Biodynamic Technologies, Inc. (1994) Summary page 1.

## Most influential descendants
- K982545: BMP Cable System (1998), 17 descendants of its own
- K031162: Smith & Nephew Orthopaedic Cabling System (2003), 10 descendants of its own
- K231873: DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional (2024), 5 descendants of its own
- K203405: EVOS Large Fragment Plating System (2021), 3 descendants of its own
- K213126: Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws (2022), 2 descendants of its own

## Indications for use
The J-Fx Cerclage System is indicated for use in general orthopaedic repairs. This includes such procedures as reinforcement of bone, reattachment of the greater trochanter, fixation of long bone fracture with grafting, fixation of patellar fractures, and closure of sternum following open heart surgery.

Source page: https://510kreport.com/device/K971682
Methodology: https://510kreport.com/methodology