# K983976: Metagen Activelock Wire Cerclage System

- Pathway: 510(k) (Traditional)
- Applicant: Metagen, LLC
- Decided: Dec 30, 1998 after 51 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 K875156 (1988). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972327: Metagen Activelock Cerclage System, Pacific Materials and Interfaces (1997) Summary page 4.
- K934557: Control Cable System, Depuy, Inc. (1994) Summary page 5.
- K844068: Trochanter Cable Grip System, Howmedica Corp. (1985) Summary page 5.
- K900926: Trochanter Cable Grip System (Add'l Indications), Howmedica Corp. (1990) Summary page 5.
- K961569: Dall-Miles Stainless Steel Beaded Cable, Howmedica Corp. (1996) Summary page 5.
- (no number) Monofilament wire from manufacturers such as Ethicon and Zimmer: named in the summary without a submission number
- (no number) Encore Orthopedics CCG Wire Cerclage System: named in the summary without a submission number

## Most influential descendants
- K063009: Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes) (2006), 1 descendant of its own
- K090686: Sic Brevetti S.R.L. Device for Sternal Synthesis (2009), 0 descendants of its own

## Indications for use
Repair of long bone fractures due to trauma or reconstruction Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy Sternotomy closure Sublaminar and intrafacet wiring of the spinal column

Source page: https://510kreport.com/device/K983976
Methodology: https://510kreport.com/methodology