# K093078: Unity Ultrasonic System with Plla Anchors

- Pathway: 510(k) (Special)
- Applicant: Bonutti Research, Inc.
- Decided: Jun 23, 2010 after 266 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Bonutti Research, Inc. ultrasonic systems (electrical generators and ultrasonic handpieces): named in the summary without a submission number
- (no number) Unity Implants: named in the summary without a submission number

## Indications for use
The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpieces. The system is to be used with Unity single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.

Source page: https://510kreport.com/device/K093078
Methodology: https://510kreport.com/methodology