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Cartiva Synthetic Cartilage Implant

by Cartiva, Inc

PMA P150017

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P150017↗

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 NumberP150017 Date1 Jul 2016ApprovedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0598-2025 FDA Class II initiated 31 Oct 2024

    Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of the following hazards: revision, removal, implant subsidence, displacement, pain, nerve damage or fragmentation.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Prosthesis, metatarsophalangeal joint cartilage replacement implant
FDA applicant
Cartiva, Inc.
PMA Number
FDA Product Code
PNW
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.

The Cartiva Synthetic Cartilage Implant is a metatarsophalangeal joint cartilage replacement prosthesis designed to restore joint function and alleviate pain in patients with degenerative or post-traumatic arthritis. This device is intended for use in the first metatarsophalangeal joint, addressing conditions such as hallux limitus, hallux rigidus, and mild hallux valgus.

The implant is supplied as a single-use device and is approved for use in the United States under an FDA Premarket Approval (PMA) application (P150017). It is intended for surgical implantation by qualified healthcare professionals in an orthopedic setting and requires sterile handling. The device is classified under the FDA’s Class III regulatory category, reflecting its high-risk nature and the need for rigorous pre-market evaluation.

Other devices from Cartiva, 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 specific conditions is the Cartiva Synthetic Cartilage Implant designed to treat in the first metatarsophalangeal joint?

    The Cartiva Synthetic Cartilage Implant is specifically designed to address painful degenerative or post-traumatic arthritis in the first metatarsophalangeal joint, including conditions like hallux limitus (limited big toe extension) and hallux rigidus (stiffness of the big toe joint). It may also be used in cases where mild hallux valgus (a bony bump on the side of the foot) is present.

  • Is the Cartiva Synthetic Cartilage Implant intended for reuse or is it a single-use device?

    The Cartiva Synthetic Cartilage Implant is explicitly supplied as a single-use device. This means it is intended for one surgical procedure only and should not be reused after implantation.

  • How should the Cartiva Synthetic Cartilage Implant be handled during surgery to ensure proper use?

    The Cartiva Synthetic Cartilage Implant requires sterile handling, as it is intended for surgical implantation. It should only be used by qualified healthcare professionals in an orthopedic setting, following standard aseptic techniques to maintain sterility before and during the procedure.

  • What regulatory pathway was followed for the approval of the Cartiva Synthetic Cartilage Implant in the United States?

    The Cartiva Synthetic Cartilage Implant received FDA approval through a Premarket Approval (PMA) application, specifically under PMA number P150017. This pathway is reserved for high-risk devices like this one, ensuring rigorous evaluation before market authorization.