Utf Stem-Reduced, Additional Sizes

by United Orthopedic Corporation

510(k) K132207

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

510(k) K132207↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK132207	Date30 Aug 2013Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K132207
FDA product code: LPH

Device class: Class II
Regulation: 21 CFR Part 888.3358
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 UTF Stem Reduced is a Hip Stem Prosthesis designed for primary total hip arthroplasty. It features a dual taper wedge stem with a reduced profile, intended to engage cortical bone for enhanced fixation and stability in the proximal femur. The design aims to provide secure axial and rotational support within the femoral canal.

This device is supplied as a reusable surgical implant, intended for use in orthopedic operating rooms under sterile conditions. It is available in additional sizes beyond the original clearance, with regulatory approval granted under an FDA 510(k) submission (K132207) as substantially equivalent to a predicate device. Compliance with orthopedic implant standards ensures compatibility with standard hip arthroplasty procedures.

From the manufacturer

The UTF (United Tapered Fit) Reduced Stem Primary Hip System offers a dual taper wedge stem design. This taper-fit concept is intended to engage the cortex in the stem corners to provide excellent fixation and superior axial and rotational stability.

Source: unitedorthopedic.com