Skip to content

STS Screw

by Ortho-Pro, LLC

510(k) K032682

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 NumberK032682 Date22 Oct 2003ClearedStatusActive

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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 STS Screw is a cannulated, threaded bone fixation implant. It is inserted between the posterior and middle facets of the subtalar joint to block posterior and inferior talar displacement, limiting excessive pronation while permitting normal joint motion.

The device features an internal hex-head for torque control and rounded external threads for insertion ease. It is supplied as a sterile, single-use implant and is authorized under FDA 510(k) clearance K032682 with product code HWC.

Other devices from Orthopro, LLC

See all devices from Orthopro, LLC →

Questions

AI-generated answers, 27 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 STS Screw used for?

    The STS Screw is inserted between the posterior and middle facets of the subtalar joint to block posterior and inferior talar displacement, which limits excessive pronation while allowing normal joint motion.

  • Is the STS Screw sterile and single-use?

    Yes, the STS Screw is supplied as a sterile, single-use implant, meaning it is intended for one procedure only and must not be reused to prevent infection or compromise device integrity.

  • What regulatory authorization does the STS Screw have?

    The STS Screw is authorized under FDA 510(k) clearance K032682 with product code HWC, indicating it was found substantially equivalent to a legally marketed predicate device.