# K992616: SDB Cerclage System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Oct 27, 1999 after 84 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 K844068 (1985). 3 ancestors in all.
10 later devices descend from it; 6 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844068: Trochanter Cable Grip System, Howmedica Corp. (1985) Summary page 1.
- K872224: Modified Trochanter Cable Grip System, Howmedica Corp. (1987) Summary page 1.
- K900926: Trochanter Cable Grip System (Add'l Indications), Howmedica Corp. (1990) Summary page 1.
- (no number) Stainless Steel cerclage wire, manufactured prior to 1976: named in the summary without a submission number

## Most influential descendants
- K101126: Pontis Sutures and Suture Anchors with Optional Crimps (2010), 3 descendants of its own
- K151888: Frontier Medical Devices In-line Orthopedic Cable Cerclage System (2015), 1 descendant of its own
- K140127: Ferrofibre Stainless Steel Suture with Crimp (2014), 1 descendant of its own
- K231333: STRETTO™ Cable System (2023), 0 descendants of its own
- K203408: Summit Patella Plating System (2021), 0 descendants of its own

## Indications for use
The SDB Cerclage System devices will be offered in two sizes of cable constructs. The large cable construct shall be indicated for general orthopedic trauma surgery involving the following: olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral and ankle fractures; acromioclavicular dislocations; prophylactic banding during total joint procedures; and temporary reduction during ORIF (Open Reduction Internal Fixation) procedures. The small cable size shall be contraindicated for use in the femur ORIF and prophylactic banding during total joint procedures. These devices are intended as single use items.

Source page: https://510kreport.com/device/K992616
Methodology: https://510kreport.com/methodology