# K973098: Compression Cerclage Gundolf CCG-GF

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics
- Decided: Oct 27, 1997 after 69 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: 1 generation back to K932024 (1995). 1 ancestor in all.
34 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932024: CCG Cerclage System, Encore Orthopedics, Inc. (1995) Summary page 2.

## Most influential descendants
- K123055: Smith & Nephew, Inc Screw and Plate System Instrumentation (2013), 33 descendants of its own
- K140814: Evos Mini-Fragment Plating System (2014), 32 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own

## Indications for use
The Compression Cerclage Gundolf CCG is suitable for particular forms of osteosynthesis, particularly for cerclage of the greater trochanter and femur associated with revision hip arthroplasties. In contrast to cerclage wires, the CCG compression band allows a functional compression to be achieved. An assumption is made that an indication for implant revision aiready exists. Reattachment of the greater trochanter. Bone support in case of a damagad proximal femur (e.g. by bone cement, loosered stem, or polyathylene wear particles), with a possible cancellous bone graft in the proximal femur area. Cerclage of bone fissures. Fracture protection during rasping of a new prosthetic canal and prior to implantation of a new stem. Closing of a cortical fenestration. Fractures in the area of the femoral stem. To improve bone-cement interface. In general, CCG and CCG-GF have the same function. In the case of conics! shape of the bone, pnmanly superior to the lesser trochanter the CCG-GF is indicated rather thar theCCG.

Source page: https://510kreport.com/device/K973098
Methodology: https://510kreport.com/methodology