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Hip Sextant Instrument System

by Surgical Planning Associates

510(k) K093491

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093491 Date9 Dec 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
OSF
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Hip Sextant Instrument System is a patient‑specific manual orthopedic stereotaxic system designed to align acetabular components during hip arthroplasty procedures. It is a manual surgical instrument that provides the surgeon with precise guidance for positioning implants in the hip joint.

The system is classified as a Class II device and has received FDA 510(k) clearance (K093491) as substantially equivalent to predicate devices. It is supplied as a manual instrument set for use in orthopedic surgery, with no specific sterility or single‑use claims noted in the available data.

Questions

AI-generated answers, 28 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 is the Hip Sextant Instrument System used for?

    The Hip Sextant Instrument System is a patient-specific manual orthopedic stereotaxic system designed to align acetabular components during hip arthroplasty procedures, providing surgeons with precise guidance for positioning implants in the hip joint.

  • How is the Hip Sextant Instrument System supplied?

    The system is supplied as a manual instrument set for use in orthopedic surgery. The available data does not specify sterility requirements or single-use claims, suggesting it may be reusable following appropriate sterilization protocols.

  • What is the regulatory classification of the Hip Sextant Instrument System?

    The Hip Sextant Instrument System is classified as a Class II medical device and has received FDA 510(k) clearance (K093491) as substantially equivalent to predicate devices. It is manufactured by Surgical Planning Associates and follows traditional clearance pathways.

  • Are there different sizes or models of the Hip Sextant Instrument System available?

    The available data does not specify different sizes or models of the Hip Sextant Instrument System. It is described as a single system designed for patient-specific use during hip arthroplasty procedures, though individual components may vary based on surgical requirements.