# K984209: Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel Cannulated Screw, Short Thread, Stainless Steel Ped

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 3, 1999 after 71 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 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 no predicate by number.

## Most influential descendants
- K082949: Orthopediatrics Bone Screws (2008), 11 descendants of its own
- K111086: Orthopediatrics Fracture and Osteotomy Bone Plate System (2011), 7 descendants of its own
- K192181: PRECICE Plating System (2019), 2 descendants of its own
- K110959: Orthopediatrics Blade Plate System (2011), 2 descendants of its own
- K162307: OrthoPediatrics Locking Proximal Femur System Cortical Screws (2016), 1 descendant of its own

## Recalls of this device
- Apr 2, 2009 · Not classified · Z-2285-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2287-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2286-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2284-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.

## Indications for use
The cannulated screws maybe used for fixation of long bone fractures and for bone reconstruction (i.e. fresh fractures, osteotomy, revision procedures where other treatments or devices have failed, arthrodesis, and in conjunction with other fixation hardware.) These cannulated screws are not to be used for spinal application or Carpal Tunnel Syndrome.

Source page: https://510kreport.com/device/K984209
Methodology: https://510kreport.com/methodology