# K043339: Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG, 3570LG, 4570LG

- Pathway: 510(k) (Traditional)
- Applicant: Xtremi-T, LLC
- Decided: Apr 18, 2005 after 136 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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: 2 generations back to K901456 (1990). 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)
- K010983: Plla Pin, Bionx Implants, Inc. (2001) Summary page 2.
- K003659: Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260, Bionx Implants, Inc. (2001) Summary page 2.
- K925098: Biofix Absorbable Self-Reinforced Poly-L-Lactide, Bioscience, Inc. (1994) Summary page 2.
- K031712: Inion Otps Biodegradable Pin, Inion, Ltd. (2003) Summary page 2.
- K040500: Arthrotek Lactonail, Arthrotek, Inc. (2004) Summary page 2.
- K011522: Resorbable Bone Pins, Biomet, Inc. (2001) Summary page 2.
- K990291: Lactosorb Bone Pin, Biomet, Inc. (1999) Summary page 2.
- K953194: Lactosorb Bone Pin, Biomet, Inc. (1995) Summary page 2.
- K890902: Biofix* Biodegradable Fixation Rod, Davis & Geck, Inc. (1989) Summary page 2.
- K901456: Orthosorb (R) Absorbable Pin, Johnson & Johnson International (1990) Summary page 2.
- K864912: PDS (Polydioxanon) Absorbable Pin, Johnson & Johnson Professionals, Inc. (1987) Summary page 2.

## Most influential descendants
- K151876: Bio2 Fusion Implant System (2015), 0 descendants of its own

## Indications for use
ReFIX Biodegradable Pins 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 fragments. For example, ReFIX pins are intended for use in the following procedures: * fixation of phalangeal fusion and fracture * repair of metacarpal fusion and fracture * fixation of hand and wrist fractures * fixation of metatarsal osteotomies * correction of hallux valgus

Source page: https://510kreport.com/device/K043339
Methodology: https://510kreport.com/methodology