# K081149: Biopro GO-EZ Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: Aug 5, 2008 after 105 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 5 cite it directly.
0 of 9 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
- K182949: Healix™ Compression Screw System (2018), 4 descendants of its own
- K202657: Javelin Tailor's Bunion Fixation System (2020), 1 descendant of its own
- K260291: Vortex5 Tailor's Bunion Correction System (2026), 0 descendants of its own
- K242896: Caliber Intramedullary Fixation System (2025), 0 descendants of its own
- K200914: Healix Compression Screw System (2020), 0 descendants of its own

## Recalls of this device
- Jun 25, 2019 · Class II · Z-2253-2019: Manufacturing flaw in the sterile barrier system
- Jun 25, 2019 · Class II · Z-2249-2019: Manufacturing flaw in the sterile barrier system
- Jun 25, 2019 · Class II · Z-2248-2019: Manufacturing flaw in the sterile barrier system
- Jun 25, 2019 · Class II · Z-2250-2019: Manufacturing flaw in the sterile barrier system
- Jun 25, 2019 · Class II · Z-2254-2019: Manufacturing flaw in the sterile barrier system
- Jun 25, 2019 · Class II · Z-2252-2019: Manufacturing flaw in the sterile barrier system
- Jun 25, 2019 · Class II · Z-2256-2019: Manufacturing flaw in the sterile barrier system
- Jun 25, 2019 · Class II · Z-2240-2019: Manufacturing flaw in the sterile barrier system
- Jun 25, 2019 · Class II · Z-2241-2019: Manufacturing flaw in the sterile barrier system
- Jun 25, 2019 · Class II · Z-2247-2019: Manufacturing flaw in the sterile barrier system
- Jun 25, 2019 · Class II · Z-2257-2019: Manufacturing flaw in the sterile barrier system
- Jun 25, 2019 · Class II · Z-2246-2019: Manufacturing flaw in the sterile barrier system
- Jun 25, 2019 · Class II · Z-2255-2019: Manufacturing flaw in the sterile barrier system
- Jun 25, 2019 · Class II · Z-2251-2019: Manufacturing flaw in the sterile barrier system

## Indications for use
Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and tendon reattachment. It is intended for but not limited to hand surgery, orthopedic surgery, plastic surgery and podiatric surgery but is not intended for use in the spine.

Source page: https://510kreport.com/device/K081149
Methodology: https://510kreport.com/methodology