# K051656: Oct (Osteochondral Transplant) Comprehensive System

- Pathway: 510(k) (Traditional)
- Applicant: Osteobiologics, Inc.
- Decided: Oct 25, 2005 after 126 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964215 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964215: Acufex Mosaicplasty Comprehensive System, Smith & Nephew Endoscopy, Inc. (1996)

## Indications for use
The OCT (Osteochondral Transplant) Comprehensive System is indicated for arthroscopic (knee and ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects.

Source page: https://510kreport.com/device/K051656
Methodology: https://510kreport.com/methodology