# K060041: Trimed Bone Plates

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Feb 7, 2006 after 32 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962616 (1996). 28 ancestors in all.
26 later devices descend from it; 9 cite it directly.
0 of 55 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 1.

## Cited in the summary but kept off the family tree
- K013655: Nxstage Dialysate Concentrate, Model RFC-100, Nxstage Medical, Inc. (2002). Our reading of the summary gave K013655, FDA’s number for Nxstage Dialysate Concentrate, Model RFC-100 (Nxstage Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Acumed Congruent Bone Plate System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K141430: Variax Distal Radius Plating System (2014), 12 descendants of its own
- K212581: VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System (2022), 4 descendants of its own
- K162841: VariAx Distal Radius Plating System, VariAx 2 System (2017), 4 descendants of its own
- K161292: Distal Radius Plating System (2016), 4 descendants of its own
- K191641: AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws (2019), 3 descendants of its own

## Recalls of this device
- Aug 24, 2018 · Class II · Z-1214-2019: The bone screw is shorter than the intended design specification.
- Aug 15, 2018 · Class II · Z-0366-2020: The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.
- Aug 29, 2016 · Class II · Z-2849-2016: TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted.

## Indications for use
The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.

Source page: https://510kreport.com/device/K060041
Methodology: https://510kreport.com/methodology