# K974245: Depuy Ace Ring Skull Pins-Mri, Depuy Ace Spring Loaded Tong Pin-Mri, Depuy Ace Fixed Tip Tong Pin-Mri

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ace Medical Co.
- Decided: May 22, 1998 after 191 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- 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
Longest line of descent: 1 generation back to K810193 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810193: Trippi-Wells Dual Purpose Universal Tong, Ace Orthopedic Manufacturing Co. (1981) Summary page 1.
- (no number) DePuy ACE Standard Skull Pin: named in the summary without a submission number
- (no number) DePuy ACE Fixed Tip Tong: named in the summary without a submission number

## Indications for use
Pins, when used in conjunction with the DePuy ACE Trippi-Wells Tong, DePuy ACE Standard Tong, DePuy ACE Universal Tong, or Open and Closed Back Halo Rings, may be used for stabilization of the cervical spine in stationary and mobile traction following: Cervical fractures * Ligamentous injury of the cervical spine » Fusion or other surgery of the cervical spine

Source page: https://510kreport.com/device/K974245
Methodology: https://510kreport.com/methodology