# K982553: Osteo Compression Hip Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Sep 22, 1998 after 62 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
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 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 DHS® Dynamic Hip Screw System: named in the summary without a submission number

## Most influential descendants
- K022139: Hip Tool Implant (2002), 7 descendants of its own
- K063709: TS-Bone Hip Tool (2007), 1 descendant of its own
- K040850: Tsy Shoulder Plate Implant (2004), 1 descendant of its own
- K072175: Titanium Hip Tool Locking Plate (2007), 0 descendants of its own
- K063033: Modification to Titanium Shoulder Plate Implant (2006), 0 descendants of its own

## Indications for use
The Osteo Compression Hip Screw System is a proximal femoral fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. It is a system which optimally engages the femoral head and permits impaction of bone fracture fragments. The Osteo I-C Humeral Nail System is intended for single use only. Indications: Cleared via 510(k)s #K971654, #K971321, #K920037 > Intracapsular fractures of the femoral neck > Intertrochanteric fractures Expanded Indication (the subject of this premarket notification) > Extracapsular fractures of the proximal femur: > basal neck fractures > trochanteric fractures > subtrochanteric fractures

Source page: https://510kreport.com/device/K982553
Methodology: https://510kreport.com/methodology