# K050388: Refix Internal Fracture Fixation Screws

- Pathway: 510(k) (Traditional)
- Applicant: Xtremi-T, LLC
- Decided: Sep 7, 2005 after 204 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: 6 generations back to K792022 (1979). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041189: Arthrex Trimit Family, Arthrex, Inc. (2004) Summary page 2.
- K992301: Reunite Screws, Biomet Manufacturing, Inc. (1999) Summary page 2.
- K964970: Biomet Bone Screw, Biomet, Inc. (1997) Summary page 2.
- K042295: Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020, Linvatec Biomaterials, Ltd. (2004) Summary page 2.
- K032447: Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially Threaded, Linvatec Biomaterials, Ltd. (2004) Summary page 2.
- K023022: Nugen FX Screw, Bionx Implants, Inc. (2002) Summary page 2.
- K012001: Smartscrew, Bionx Implants, Ltd. (2001) Summary page 2.
- K003077: Smartscrew Model 222006...227510, Bionx Implants, Ltd. (2001) Summary page 2.
- K992947: Cannulated Smartscrew Models 224540C, 224570C, Bionx Implants, Ltd. (1999) Summary page 2.
- K974876: Bionx Distal Radius Screw, Bionx Implants, Inc. (1998) Summary page 2.
- K030900: Inion Otps Biodegradable Fixaton System, Inion, Ltd. (2003) Summary page 2.
- K023887: Inion Otps Biodegradable Mini Plating System, Inion, Ltd. (2003) Summary page 2.

## Indications for use
ReFIX Screws are intended for use in the fixation and/or alignment of fragments of fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or alignment of apical fragments, osteochondral fragments and cancellous/non-load bearing bone fragments. For example, ReFIX Screws are intended for use in fractures of the ankle, colles, distal radius, hand and wrist, humeral condyle, malleolus, metacarpals, olecranon, phalanges and the radial head; fusions of metacarpals, metatarsals and phalanges; and correction of hallux valgus.

Source page: https://510kreport.com/device/K050388
Methodology: https://510kreport.com/methodology