> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Orthopedic Surgical Instruments Put Into Class 2
- URL: https://www.fdaweb.com/orthopedic-surgical-instruments-put-into-class-2/
- Published: 2019-10-25T12:00:00.000Z
- Updated: 2026-09-15T01:59:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145337

*Federal Register* notice: FDA has classified orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into Class 2 (special controls). This action was in response to a 1/2018 request from Cartiva Inc. for accessory classification of its reusable implantation instruments for the Cartiva Synthetic Cartilage Implant. Such devices are identified by FDA as hand-held devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device also includes instruments specific to the geometry of the implant. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-10-25/pdf/2019-23307.pdf?ref=fdaweb.com).