# K091156: Trimed Sterile Product

- Pathway: 510(k) (Special)
- Applicant: TriMed, Inc.
- Decided: Jul 15, 2009 after 85 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 8 generations back to K962616 (1996). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951302: Small Fragment Plates and Screws, Medpac (1995) Summary page 1.
- K951303: SFC, Medpac (1995) Summary page 1.
- K010545: TBW, Tri-Med, Inc. (2001) Summary page 1.
- K040112: Trimed Bearing Plate; Trimed Volar Bearing Plate, Tri-Med, Inc. (2004) Summary page 2.
- K043263: Trimed Osteotomy Plate, TriMed, Inc. (2005) Summary page 2.
- K060041: Trimed Bone Plates, TriMed, Inc. (2006) Summary page 2.
- K081348: Tenodesis Cross Screw, Interference Screw, Suture Bead, TriMed, Inc. (2008) Summary page 2.

## Indications for use
Used as an aid to the healing of volar rim fractures of the distal radius. Used as an aid to the treatment of certain types of fractures involving small fragments. Specifically: - Cortical fragments large and strong enough to allow application of the device with fixation to an adjacent stable cortex of cortical bone. - An intraarticular fragment large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone. -A combination of the above Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecranon, patella, medial malleolus, lateral malleolus, distal ulna, distal humerus, and proximal humerus. The decision to use a specific implant as well as the size and shape of the implant used must be based on sound medical judgement that takes into consideration factors such as the circumstances and configuration of-the injury. 1. Fixation of fractures or non-unions of the distal radius 2. Osteotomies of the distal radius to correct malunion. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna. The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus. The TriMed Tenodesis Cross Screw and Interference Screw are intended to be used as an aid for fixation of soft tissue grafts to bone. Specific indications for use include: Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, Tendon Transfer in the hand and wrist. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruciton, Tendon Transfers in the foot and ankle. The TriMed Suture Bead is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting. The Suture Beads are also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment. The TriMed Suture Bead is not indicated for use within intra-articular sites.

Source page: https://510kreport.com/device/K091156
Methodology: https://510kreport.com/methodology