# K083144: Acumed Clavicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Jun 16, 2009 after 236 days
- Product code: JDW (Pin, Fixation, Threaded)
- 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 K903258 (1990). 7 ancestors in all.
1 later device descends from it; 1 cites 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)
- K991649: Depuy Rockwood Clavicle Pin, Depuy, Inc. (1999) Summary page 2.
- K934148: True/Flex Clavicle Rods, Applied Osteo Systems, Inc. (1994) Summary page 2.
- K903258: Hagie Pin, Onyx Medical Corp. (1990) Summary page 2.
- K863734: Steinmann (Threaded/Calibrated),Knowles&Hogie Pins, Micro-Aire Surgical Instruments, Inc. (1986) Summary page 2.
- K792022: Herbert Bone Screw, Zimmer, Inc. (1979) Summary page 2.

## Most influential descendants
- K242896: Caliber Intramedullary Fixation System (2025), 0 descendants of its own

## Indications for use
The Acumed Clavicle Screw System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Source page: https://510kreport.com/device/K083144
Methodology: https://510kreport.com/methodology