# K141301: Maxlock Extreme Elbow Fracture System

- Pathway: 510(k) (Traditional)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Jul 11, 2014 after 53 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: 12 generations back to K954385 (1996). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123203: Maxlock Extreme System Model MXL, Orthohelix Surgical Designs, Inc. (2012) Summary page 1.
- K073527: Variax Elbow System, Howmedica Osteonics Corp. (2008) Summary page 1.
- K093433: Variax Elbow System Plate Line Extension, Howmedica Osteonics Corp. (2010). Our reading of the summary gave K092433, FDA’s number for DYSIS (Forth Photonics Hellas SA). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Stryker VariAx Elbow System”.
- K101056: Variax Elbow System, Howmedica Osteonics Corp. (2010) Summary page 2.
- K082300: Anatomic Locking Plating System, DePuy Orthopaedics, Inc. (2009) Summary page 2.
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 2.

## Indications for use
The MaxLock Extreme System is indicated for the following: *The MaxLock Extreme Universal Module is indicated for use in 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, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle. *The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle. *The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients. *The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

Source page: https://510kreport.com/device/K141301
Methodology: https://510kreport.com/methodology