# K991723: Transfx Multi Pin Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Immedica, Inc.
- Decided: Jul 22, 1999 after 63 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: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K061759: Reprocessed External Fixation Device (2006), 0 descendants of its own

## Recalls of this device
- May 1, 2009 · Not classified · Z-1533-2009: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- May 1, 2009 · Not classified · Z-1532-2009: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- May 1, 2009 · Not classified · Z-1538-2009: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- May 1, 2009 · Not classified · Z-1534-2009: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- May 1, 2009 · Not classified · Z-1535-2009: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- May 1, 2009 · Not classified · Z-1536-2009: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- May 1, 2009 · Not classified · Z-1537-2009: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.

## Indications for use
Unstable fractures of the distal radius: intra-articular, extra-articular, and preliminary fixation before internal fixation. Fractures and fracture dislocations of the hand, wrist, forearm, mandible, foot, ankle, and long bones; joint fusion, osteotomies, and peri-articular fractures.

Source page: https://510kreport.com/device/K991723
Methodology: https://510kreport.com/methodology
