# K961497: Profyle Titanium Hand and Small Fragment System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Jun 28, 1996 after 71 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.
628 later devices descend from it; 9 cite it directly.
0 of 629 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) Luhr® Fixation System: named in the summary without a submission number
- (no number) Synthes® Small Fragment and Mini Set: named in the summary without a submission number
- (no number) Wurzburg° Titanium Mini Bone Plates and Screws: named in the summary without a submission number

## Most influential descendants
- K040598: KLS Martin Hand Plating System (2004), 360 descendants of its own
- K050868: Maxlock (2005), 343 descendants of its own
- K073624: Modular Foot System (2008), 342 descendants of its own
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology (2010), 339 descendants of its own
- K021626: Hallu Plates (2002), 280 descendants of its own

## Indications for use
The system is intended for use in internal fixation of small bones including the hand, foot, and craniomaxillofacial skeleton.

Source page: https://510kreport.com/device/K961497
Methodology: https://510kreport.com/methodology