# K081813: Universal Compression Fracture Repair System

- Pathway: 510(k) (Traditional)
- Applicant: U.S. Implant Solutions, LLC
- Decided: Mar 12, 2009 after 259 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
Longest line of descent: 3 generations back to K922322 (1992). 9 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954682: Washer, Bolt, Nut, Orthopedic, Linvatec Corp. (1996) Summary page 1.
- K024086: Propeller Head Small Cannulated Screw System, Biomet Orthopedics, Inc. (2003) Summary page 1.
- K983165: Osteo 4.0MM Cannulated Screw System, Osteonics Corp. (1998) Summary page 1.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- (no number) Zimmer 878 Barr Bolt (Pre-amendment): named in the summary without a submission number

## Most influential descendants
- K210754: Cannulated Fasteners and Nuts (2021), 3 descendants of its own
- K211290: Cannulated Fasteners and Nuts (2021), 2 descendants of its own
- K242691: OsteoCentric Technologies Cannulated Fasteners and Nuts (2024), 0 descendants of its own
- K230226: Integrity-SI® Fusion System (2023), 0 descendants of its own

## Indications for use
The CompresSURE System is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e.- the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nut-and-bolt system, as discussed above. The system is not intended for spinal use.

Source page: https://510kreport.com/device/K081813
Methodology: https://510kreport.com/methodology