# K961413: Synthes Anatomical Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 7, 1996 after 117 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
93 later devices descend from it; 8 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes PC-Fix: named in the summary without a submission number
- (no number) Condylar Plate 95°: named in the summary without a submission number
- (no number) Condylar Buttress Plate: named in the summary without a submission number
- (no number) 4.5 mm Cortex Screws: named in the summary without a submission number
- (no number) 6.5 mm Cancellous Screws: named in the summary without a submission number

## Most influential descendants
- K042695: NCB Plating System (2004), 68 descendants of its own
- K061211: NCB Plating System, Proximal Tibia Plates (2006), 25 descendants of its own
- K081759: NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking System, 3.5MM Tivanium TI-6AL-4V (2008), 21 descendants of its own
- K121672: Aft Proximal Humerus Fracture Plate (2012), 20 descendants of its own
- K100111: NCB Periprosthetic Femur Polyaxial Locking Plate System (2010), 18 descendants of its own

## Indications for use
Synthes ALPS is a plate and screw system intended to treat fractures of various long bones, including the radius, ulna, humerus, tibia, fibula and femur.

Source page: https://510kreport.com/device/K961413
Methodology: https://510kreport.com/methodology