# K132898: A.L.P.S. Calcaneal Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Nov 19, 2013 after 64 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: 4 generations back to K915818 (1992). 9 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093474: Depuy Fracture and Fusion Plating System, DePuy Orthopaedics, Inc. (2010) Summary page 1.
- K090582: Calcaneal Fracture Plate System, Tornier, Inc. (2009) Summary page 1.
- (no number) A.L.P.S screw system: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K093465: Fusion System, Eclipsemed Global, Inc. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K171808: TDM Plate and Screw System (2018), 6 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K221150: Advanced Bone Plate (2023), 1 descendant of its own
- K190391: TDM Plate and Screw Systems (2019), 1 descendant of its own
- K261830: FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) (2026), 0 descendants of its own

## Indications for use
The Biomet A.L.P.S Calcaneal Plating System is intended for fixation of fractures, fusions, and osteotomies of the calcaneus.

Source page: https://510kreport.com/device/K132898
Methodology: https://510kreport.com/methodology