# K181348: Cartiva SCI Disposable Instrumentation Set

- Pathway: 510(k) (Special)
- Applicant: Cartiva, Inc.
- Decided: Jun 20, 2018 after 30 days
- Product code: QBO (Instruments Designed For Press-Fit Osteochondral Implants)
- Device class: 2
- Regulation: 21 CFR 888.4505
- 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) Cartiva SCI Instrumentation: named in the summary without a submission number

## Indications for use
Orthopedic surgical instrumentation supplied by Cartiva, Inc. is indicated for use in the press-fit fixation of the implantable medical device products manufactured by Cartiva, Inc.

Source page: https://510kreport.com/device/K181348
Methodology: https://510kreport.com/methodology