Skip to content

Agili-C

by Smith & Nephew, Inc.

PMA P210034

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P210034↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP210034 Date29 Mar 2022ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic name
Implant, resorbable, for articular osteochondral repair
FDA applicant
Smith and Nephew, Inc.
PMA number
FDA product code
QRU
Device class
Class III
Advisory committee
Orthopedic
FDA decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Agili-C is an implant, resorbable, for articular osteochondral repair. It is indicated for the treatment of International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).

Supplied by Smith & Nephew, Inc., the device has received FDA PMA approval (P210034). It is intended for use in orthopedic settings as a resorbable scaffold for cartilage repair, with no claims made regarding sterility, single-use status, MRI safety, sizes, or storage conditions in the provided data.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Agili-C implant used for?

    The Agili-C implant is indicated for the treatment of International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).

  • Who manufactures the Agili-C implant?

    The Agili-C implant is manufactured by Smith & Nephew, Inc., located in Andover, MA.

  • What regulatory pathway was used for the Agili-C implant?

    The Agili-C implant received approval through the FDA Premarket Approval (PMA) pathway, with PMA number P210034 and decision date of March 29, 2022.