# K132296: D-Rad Smart Pack

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 7, 2014 after 168 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962616 (1996). 42 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity, Smith & Nephew, Inc. (2005) Summary page 2.
- K083032: Peri-Loc Bone Plating and Screw System, Smith & Nephew, Inc. (2009) Summary page 2.
- (no number) Bone Plate System: named in the summary without a submission number

## Most influential descendants
- K161665: VLP Wrist Fracture System (2016), 10 descendants of its own
- K181533: EVOS Wrist Fracture Plating System (2018), 9 descendants of its own
- K210837: Smith & Nephew Plates and Screws (2021), 7 descendants of its own
- K213126: Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws (2022), 2 descendants of its own
- K233017: TM Plating System (2023), 1 descendant of its own

## Recalls of this device
- Mar 7, 2018 · Class II · Z-1317-2018: One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.
- Mar 9, 2017 · Class II · Z-1855-2017: The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
- Mar 9, 2017 · Class II · Z-1857-2017: The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
- Mar 9, 2017 · Class II · Z-1856-2017: The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

## Indications for use
The D-RAD SMART PACK is intended for the fiation of fractures involving the distal radius.

Source page: https://510kreport.com/device/K132296
Methodology: https://510kreport.com/methodology