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Signature ONE System

by Orthosoft Inc. (d/b/a) Zimmer CAS 4 variants

510(k) K260104

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK260104 Date4 Feb 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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
QHE
Device Class
Class II
Regulation
21 CFR Part 888.3660
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 Signature ONE System is a Shoulder Arthroplasty Implantation System, designed to assist in pre-operative planning and intra-operative guidance for shoulder arthroplasty procedures. It utilises patient-specific radiological images and anatomical landmarks to enhance surgical precision, ensuring accurate placement of surgical instruments during shoulder joint reconstruction.

This system is intended for use in orthopaedic surgical settings and is supplied as a reusable device. It is classified under FDA product code QHE and has received FDA 510(k) clearance through the Special 510(k) pathway. The device is regulated as a Class II medical device, adhering to the requirements outlined in regulation number 888.3660. No sterility or single-use specifications are indicated in the provided data.

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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 Signature ONE System used for?

    The Signature ONE System is designed to assist orthopedic surgeons in pre-operative planning and intra-operative guidance during shoulder arthroplasty procedures. It leverages patient-specific radiological images and anatomical landmarks to enhance precision, ensuring accurate placement of surgical instruments and implants for shoulder joint reconstruction.

  • Is the Signature ONE System reusable or single-use?

    The Signature ONE System is supplied as a reusable device. This classification aligns with its intended use in multiple surgical procedures, allowing for cost-effective and efficient deployment in orthopedic settings.

  • What regulatory pathway was followed for the Signature ONE System?

    The Signature ONE System received FDA 510(k) clearance through the Special 510(k) pathway, demonstrating its substantial equivalence to a predicate device. It is classified as a Class II medical device under FDA regulation number 888.3660, adhering to stringent requirements for orthopedic surgical instruments.

  • Does the Signature ONE System require sterility for use?

    The provided data does not specify any sterility requirements for the Signature ONE System. As a reusable device, proper cleaning and sterilization protocols must be followed by the facility to ensure safe and effective use across multiple procedures.

  • How does the Signature ONE System improve surgical outcomes?

    The system enhances surgical outcomes by integrating patient-specific radiological data with anatomical landmarks, enabling precise pre-operative planning and real-time intra-operative guidance. This reduces the risk of implant misplacement, improves alignment accuracy, and supports more consistent and predictable results in shoulder arthroplasty procedures.