# K974876: Bionx Distal Radius Screw

- Pathway: 510(k) (Traditional)
- Applicant: Bionx Implants, Inc.
- Decided: Mar 20, 1998 after 81 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K792022 (1979). 5 ancestors in all.
419 later devices descend from it; 8 cite it directly.
0 of 425 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.
- K962616: Synthes Dorsal Distal Radius Plate (DDRP) System, Synthes (Usa) (1996) Summary page 1.
- K953644: Volar Distal Radius Plate, Synthes (Usa) (1996) Summary page 1.
- K953714: Zimmer Reconstruction System Symphyseal Bone Plate, Zimmer, Inc. (1995) Summary page 1.
- K961608: Synthes (U.S.a.) Polypin, Synthes (Usa) (1997) Summary page 2.

## Most influential descendants
- K992947: Cannulated Smartscrew Models 224540C, 224570C (1999), 413 descendants of its own
- K012001: Smartscrew (2001), 337 descendants of its own
- K030900: Inion Otps Biodegradable Fixaton System (2003), 333 descendants of its own
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), 306 descendants of its own
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), 217 descendants of its own

## Indications for use
The Bionx Biodegradable, Threaded Distal Radius Screw is intended for use in the fixation of cancellous bone fractures in combination with appropriate postoperative cast immobilization. The device will specifically be indicated for use in open reduction and internal fixation of Frykman type I - IV dorsally displaced Colles fractures, osteotomies, and carpal fusions of the distal radius.

Source page: https://510kreport.com/device/K974876
Methodology: https://510kreport.com/methodology