# K972327: Metagen Activelock Cerclage System

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Materials and Interfaces
- Decided: Aug 11, 1997 after 49 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: 2 generations back to K875156 (1988). 9 ancestors in all.
3 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)
- K932024: CCG Cerclage System, Encore Orthopedics, Inc. (1995) Summary page 5.
- K934557: Control Cable System, Depuy, Inc. (1994) Summary page 6.
- K844068: Trochanter Cable Grip System, Howmedica Corp. (1985) Summary page 6.
- K900926: Trochanter Cable Grip System (Add'l Indications), Howmedica Corp. (1990) Summary page 6.
- K961569: Dall-Miles Stainless Steel Beaded Cable, Howmedica Corp. (1996) Summary page 6.
- K934058: Dall Miles System Minicleat, Howmedica Corp. (1994) Summary page 6.
- K961283: Dall-Miles Homogenous Vitallium Cable, Howmedica Corp. (1996) Summary page 6.
- (no number) Monofilament suture wire: named in the summary without a submission number

## Most influential descendants
- K983976: Metagen Activelock Wire Cerclage System (1998), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K972327
Methodology: https://510kreport.com/methodology