# K031438: Acumed Small Bone Locking Rod System II

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Jul 17, 2003 after 72 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913949 (1992). 3 ancestors in all.
24 later devices descend from it; 9 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951673: Rod, Fixation, Intramedullary and Accessories, Acu Med, Inc. (1995) Summary page 1.
- K982953: Titanium Intramedullary Nails-Various Styles, Biomet, Inc. (1998) Summary page 1.
- K913949: True/Flex Humerus, Ulna & Radius Intramed Rods Sys, Applied Osteo Systems, Inc. (1992) Summary page 1.
- (no number) Biomet Inc. S.S.T. Small Bone Locking Nail: named in the summary without a submission number

## Most influential descendants
- K071944: Acumed Small Bone Locking System II (2007), 15 descendants of its own
- K143276: Acumed Small Bone IM Nail System (2015), 10 descendants of its own
- K142945: Sonoma Fibula Repair System (2015), 10 descendants of its own
- K160069: Sonoma Fibula Repair System (2016), 9 descendants of its own
- K032548: IP-XS Compression Nail System (2003), 5 descendants of its own

## Recalls of this device
- Aug 21, 2008 · Not classified · Z-1552-2010: Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material.

## Indications for use
The Acurned Small Bone Locking System I I and accessories are designed specifically for fractures and osteotomies of the fibula, radius, and ulna.

Source page: https://510kreport.com/device/K031438
Methodology: https://510kreport.com/methodology