# K961213: Alta Dome and Plunger (Mec Hip Bolt)

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jun 13, 1996 after 77 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Alta® Dome and Plunger: named in the summary without a submission number
- (no number) Howmedica Haig Nail: named in the summary without a submission number
- (no number) Zimmer Haig Nail: named in the summary without a submission number

## Most influential descendants
- K102528: N-Force Fixation System (2011), 5 descendants of its own
- K132244: N-Force Fixation System (2014), 3 descendants of its own
- K151146: N-Force Fixation System (2015), 1 descendant of its own
- K142776: Flow-Screw (2015), 1 descendant of its own
- K173556: Injection Screw (2018), 0 descendants of its own

## Indications for use
The Alta® Dome and Plunger, previously cleared by the FDA, is a titanium alloy device for the fixation of intracapsular and extracapsular (intertrochanteric) fractures of the hip.

Source page: https://510kreport.com/device/K961213
Methodology: https://510kreport.com/methodology