# K981372: Synthes 3.0 MM PC-Fix System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 11, 1998 after 25 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.
710 later devices descend from it; 1 cites it directly.
1 of 711 devices in its family (counting itself) has 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

## Most influential descendants
- K991407: Synthes Locking Calcaneal Plates (1999), 709 descendants of its own
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) (2003), 690 descendants of its own
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity (2005), 584 descendants of its own
- K062216: Peri-Loc Periarticular Locked Plating System (2006), 501 descendants of its own
- K071563: Peri-Loc Periarticular Locked Plating System (2007), 495 descendants of its own

## Indications for use
The Synthes 3.0 mm PC-Fix™ is a long bone and small bone plate and screw system, intended to treat fractures of various bones, including the radius, ulna, distal tibia, pelvis, clavicle, fibula, humerus, and scapula.

Source page: https://510kreport.com/device/K981372
Methodology: https://510kreport.com/methodology