# K092528: Biomet Forerunner Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Trauma (Aka Ebi, Lp)
- Decided: May 21, 2010 after 276 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: 2 generations back to K043059 (2005). 5 ancestors in all.
53 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 2.
- K080295: Charlotte Claw 3.5, Wrightmedicaltechnologyinc (2008) Summary page 2.
- K051908: Charlotte Compression Plate, Wrightmedicaltechnologyinc (2005) Summary page 2.

## Most influential descendants
- K113048: Maxlock Extreme System (2012), 52 descendants of its own
- K122005: Maxlock Extreme System (2012), 39 descendants of its own
- K123203: Maxlock Extreme System Model MXL (2012), 38 descendants of its own
- K132591: Maxlock Extreme System (2013), 32 descendants of its own
- K153379: AxSOS 3Ti (2016), 25 descendants of its own

## Indications for use
The Biomet ForerunnerTM Plating System is used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand, and middle foot bones. This 510(k) expands the indications for use to the forefoot, and adds specific indications for midfoot/forefoot procedures: 1. Treatment of fractures and fracture-dislocations of the midfoot/forefoot 2. Malunions 3. Non-unions 4. Joint fusions/arthrodesis 5. Corrective osteotomies for deformities These procedures in the midfoot/forefoot may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

Source page: https://510kreport.com/device/K092528
Methodology: https://510kreport.com/methodology