# K202016: Dall-Miles® Cable System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Oct 16, 2020 after 87 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: 3 generations back to K844068 (1985). 14 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070170: Dall-Miles System, Stryker Orthopaedics (2007) Summary page 4.
- K971741: Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable, Howmedica Corp. (1997) Summary page 4.
- K961283: Dall-Miles Homogenous Vitallium Cable, Howmedica Corp. (1996) Summary page 4.
- K953818: Dall-Miles Suture/Beaded Cable, Howmedica Corp. (1995) Summary page 4.
- K945294: Dall Miles System Homogeneous Vitallium Cable, Howmedica Corp. (1995) Summary page 4.
- K934058: Dall Miles System Minicleat, Howmedica Corp. (1994) Summary page 4.
- K900926: Trochanter Cable Grip System (Add'l Indications), Howmedica Corp. (1990) Summary page 4.

## Most influential descendants
- K233498: Stryker Orthopaedics Hip Systems Labeling Update (2023), 4 descendants of its own
- K243784: Stryker Orthopaedics Hip Devices Labeling Update (2025), 2 descendants of its own
- K231257: Pangea Utility Plating System, Pangea Platform (2023), 1 descendant of its own
- K261624: Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component (2026), 0 descendants of its own
- K261481: Pangea Femur Reconstruction System (2026), 0 descendants of its own

## Indications for use
The DALL-MILES System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach. The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment. The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only. The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation. The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device. The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies.

Source page: https://510kreport.com/device/K202016
Methodology: https://510kreport.com/methodology