# K031162: Smith & Nephew Orthopaedic Cabling System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: May 1, 2003 after 17 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). 18 ancestors in all.
10 later devices descend from it; 7 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842977: Orthopaedic Cable System, Richards Medical Co., Inc. (1984) Summary page 1.
- K875156: Stainless Steel Orthopaedic Cable System, Richards Medical Co., Inc. (1988)
- K924141: Orthopaedic Polyethylene Cable, Smith & Nephew Richards, Inc. (1993) Summary page 1.
- K982545: BMP Cable System, Biomet, Inc. (1998) Summary page 1.
- K971741: Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable, Howmedica Corp. (1997) Summary page 1.
- K974016: Cerclage Cable with Hex Button, Pioneer Surgical Technology (1997) Summary page 1.
- (no number) Zimmer’s Cable-Ready Cable Grip System: named in the summary without a submission number

## Most influential descendants
- 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
- K223762: Smith & Nephew ACCORD™ Cable System (2023), 1 descendant of its own
- K043252: Cabling System Trochanter Hook (2005), 1 descendant of its own
- K252019: CurvaFix Low Profile System (2025), 0 descendants of its own

## Indications for use
General orthopaedic repair procedures including patella fractures, general cerclage, trochanteric reattachment, femur and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nailing and screwing fixation techniques. Trochanteric reattachment whenever the trochanter is osteomized in any of the procedures listed below. 1. Primary total hip arthroplasty. 2. Revision total hip arthroplasty. 3. Any procedure using anterolateral or lateral approaches.

Source page: https://510kreport.com/device/K031162
Methodology: https://510kreport.com/methodology