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Prime Cemented Small Femoral Stem

by Orthopaedic Innovations, Inc.

510(k) K953033

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK953033 Date13 Sep 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Prime Cemented Small Femoral Stem is a metal/polymer semi-constrained cemented prosthesis intended to be implanted to replace a hip joint. It limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint.

The device is supplied as a single-use implant and is not MRI safe. It is authorized under FDA 510(k) clearance K953033 with product code JDI, cleared on September 13, 1995. The device is manufactured by Orthopaedic Innovations, Inc. and is available in various sizes as specified by the model numbers.

Other devices from Orthopaedic Innovations, Inc.

See all devices from Orthopaedic Innovations, Inc. →

Questions

AI-generated answers, 1 Oct 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 Prime Cemented Small Femoral Stem used for?

    The Prime Cemented Small Femoral Stem is a metal/polymer semi-constrained cemented prosthesis intended to replace a hip joint. It limits translation and rotation in one or more planes through the geometry of its articulating surfaces without any linkage across-the-joint.

  • How is the Prime Cemented Small Femoral Stem supplied?

    The device is supplied as a single-use implant and is not MRI safe. It is available in various sizes as specified by the model numbers, manufactured by Orthopaedic Innovations, Inc.

  • What is the regulatory status of the Prime Cemented Small Femoral Stem?

    The device is authorized under FDA 510(k) clearance K953033 with product code JDI, cleared on September 13, 1995. It was reviewed by the Orthopedic advisory committee and determined to be substantially equivalent.

  • Can the Prime Cemented Small Femoral Stem be reused?

    No, the Prime Cemented Small Femoral Stem is supplied as a single-use implant and should not be reused. It is not MRI safe, which is consistent with single-use medical devices that may contain materials affected by magnetic fields.