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Ascension MCP

by Smith & Nephew, Inc.

PMA P000057

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P000057↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP000057 Date19 Nov 2001ApprovedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0550-03 FDA Unclassified (pre-2012) initiated 31 Oct 2002 on shared PMA P000057

    Literature approved for international distribution only was distributed domestically.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic name
Finger semi-constrained pyrolytic carbon uncemented prosthesis
PMA number
FDA product code
NEG
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 Ascension MCP is a finger semi-constrained pyrolytic carbon uncemented prosthesis indicated for total joint replacement of the index, long, ring, and small finger metacarpophalangeal joints. It is used in cases exhibiting pain, limited motion, or inadequate bony alignment due to articular destruction or degenerative disease related to rheumatoid arthritis, lupus erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissue reconstruction can provide adequate stabilization.

Supplied by Smith & Nephew, Inc., this device is authorized under FDA PMA (P000057) and classified as a Class III device. It is intended for surgical implantation in orthopedic settings and is not described as sterile, single-use, reusable, or MRI-safe in the provided data. No size variations or storage conditions are specified in the source information.

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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 joints does the Ascension MCP prosthesis replace?

    The Ascension MCP prosthesis is indicated for total joint replacement of the index, long, ring, and small finger metacarpophalangeal joints, as specified in the device's indications for use statement.

  • Is the Ascension MCP prosthesis cemented or uncemented?

    The Ascension MCP prosthesis is explicitly described as an uncemented prosthesis in both the generic name and the device name fields: 'Finger semi-constrained pyrolytic carbon uncemented prosthesis'.

  • What conditions is the Ascension MCP prosthesis intended to treat?

    The device is intended for use in joints affected by articular destruction or degenerative disease related to rheumatoid arthritis, lupus erythematosus, osteoarthritis, or post-traumatic arthritis, provided that soft tissue reconstruction can provide adequate stabilization.