# K982347: Depuy Ace Timax Pilon Plate

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ace Medical Co.
- Decided: Aug 31, 1998 after 56 days
- Product code: HRS (Plate, Fixation, Bone)
- 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.
262 later devices descend from it; 3 cite it directly.
0 of 263 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) Synthes Stainless Steel Cloverleaf Plate: named in the summary without a submission number

## Most influential descendants
- K031666: Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS (2003), 161 descendants of its own
- K062747: Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM (2006), 143 descendants of its own
- K033639: Acumed Lower Extremity Congruent Plate System (2004), 98 descendants of its own
- K073375: Newdeal Tibiaxys System (2008), 73 descendants of its own
- K110670: VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates (2011), 69 descendants of its own

## Indications for use
Pilon fractures - distal tibial intra-articular fractures High medial malleolar fractures Low Boot top type rotational distal extra-articular shaft fractures

Source page: https://510kreport.com/device/K982347
Methodology: https://510kreport.com/methodology