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OTI Modular Shoulder System

by Osteoimplant Technology, Inc.

510(k) K982886

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 NumberK982886 Date5 Oct 1998ClearedStatusActive

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  • Withdrawn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
HSD
Device Class
Class II
Regulation
21 CFR Part 888.3690
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 OTI Modular Shoulder System is a modular orthopedic implant designed for shoulder arthroplasty. It consists of components that allow for customizable fixation and reconstruction of the shoulder joint, including humeral and glenoid elements, to address degenerative or traumatic joint conditions. The system is categorized under the FDA product code HSD (Hemiarthroplasty, Shoulder).

This device is intended for use in orthopedic surgical settings and is supplied as a sterile, single-use or reusable system depending on component configuration. It requires surgical implantation by trained professionals and is regulated under FDA 510(k) clearance (K982886) as substantially equivalent to a predicate device. Components may vary in size and configuration to accommodate individual patient anatomy, with sterility maintained through manufacturer-provided packaging.

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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 OTI Modular Shoulder System used for?

    The OTI Modular Shoulder System is designed for shoulder arthroplasty, addressing degenerative or traumatic joint conditions by enabling customizable reconstruction. Its modular components—humeral and glenoid elements—allow surgeons to tailor fixation to individual patient anatomy, improving joint stability and function.

  • Is the OTI Modular Shoulder System single-use or reusable?

    The system’s sterility and reuse depend on component configuration. Some parts may be intended for single-use, while others are designed for reuse under sterile conditions as specified by the manufacturer’s packaging and protocols. Always follow the provided instructions to maintain sterility and compliance.

  • How does the modularity of this system benefit patients?

    The modular design allows surgeons to select and combine components (e.g., humeral and glenoid elements) based on a patient’s specific anatomy and clinical needs. This customization enhances precision in fixation, reduces implant loosening risks, and improves long-term outcomes for shoulder arthroplasty.

  • What sizes or configurations are available for the OTI Modular Shoulder System?

    The system offers varied sizes and configurations to accommodate diverse patient anatomies. Exact dimensions and options are detailed in the manufacturer’s technical documentation, which includes sizing guides and component compatibility charts for humeral and glenoid elements.

  • How should the OTI Modular Shoulder System be stored?

    Storage follows manufacturer guidelines to preserve sterility and functionality. Components should be kept in their original, sealed packaging until use, protected from moisture, heat, and physical damage. Reusable parts must undergo proper cleaning and sterilization per protocol before reuse.