# K243761: A.L.P.S. Small Fragment Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics
- Decided: Feb 19, 2025 after 75 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). 97 ancestors in all.
No later device cites it as a predicate yet.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111663: Trauma Internal Fixation Systems, DePuy Orthopaedics, Inc. (2012) Summary page 5.
- K072083: Small Fragment Locking Plating System, DePuy Orthopaedics, Inc. (2007) Summary page 5.
- K920738: Ace 100 Degrees Tubular Plate, Ace Orthopedic Manufacturing Co. (1992) Summary page 5.
- K895107: Ace Orthopaedic Washers, Buckman Co., Inc. (1989) Summary page 5.
- K083843: Locking Anatomic & Composite Plating System, DePuy Orthopaedics, Inc. (2009) Summary page 5.

## Indications for use
The A.L.P.S. Small Fragment Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone. The 100 Degree Tubular Plate is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, distal tibia (including intra-articular), fibula, particularly in osteopenic bone. Washers are intended to be used in conjunction with bone screws.

Source page: https://510kreport.com/device/K243761
Methodology: https://510kreport.com/methodology