# K040265: Little Grafter Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: May 28, 2004 after 113 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K792022 (1979). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792022: Herbert Bone Screw, Zimmer, Inc. (1979) Summary page 1.
- K944330: Acutrak Plus Fixation System, Acu Med, Inc. (1995) Summary page 1.
- K000080: Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2000) Summary page 1.
- K021556: Synthes 2.4 MM Cannulated Compression Screw, Synthes (Usa) (2002) Summary page 1.
- K020222: Wisorb Malleolar Screw, Cambridge Scientific, Inc. (2002) Summary page 1.

## Most influential descendants
- K073312: Osteotrans-OT Screw (2008), 0 descendants of its own

## Indications for use
The Little Grafter TM Screw is indicated for fixation of fractures of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.

Source page: https://510kreport.com/device/K040265
Methodology: https://510kreport.com/methodology