Skip to content

Sulzer Orthopedics Allegretto Unicompartmental Knee

by Sulzer Orthopedics, Inc.

510(k) K011954

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 NumberK011954 Date19 Sep 2001ClearedStatusActive

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  • Withdrawn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
HSX
Device Class
Class II
Regulation
21 CFR Part 888.3520
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Sulzer Orthopedics Allegretto Unicompartmental Knee is a prosthesis for the knee, femorotibial, non-constrained, cemented, metal/polymer device. It is indicated for use in the treatment of unicompartmental noninflammatory degenerative joint disease, including osteoarthritis, avascular necrosis, and arthritis secondary to various diseases and anomalies.

This device was submitted as a traditional 510(k) premarket notification by Sulzer Orthopedics, Inc. and received FDA clearance on September 19, 2001, under k-number K011954. It is classified under product code HSX and was reviewed by the Orthopedic advisory committee. The device is supplied as a sterile, single-use implant for orthopedic surgical procedures.

Other devices from Sulzer Orthopedics, Inc.

See all devices from Sulzer Orthopedics, Inc. →

Questions

AI-generated answers, 24 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 Sulzer Orthopedics Allegretto Unicompartmental Knee used for?

    It is indicated for the treatment of unicompartmental noninflammatory degenerative joint disease, including osteoarthritis, avascular necrosis, and arthritis secondary to various diseases and anomalies, as stated in the device description.

  • How is the Sulzer Orthopedics Allegretto Unicompartmental Knee supplied and is it reusable?

    The device is supplied as a sterile, single-use implant for orthopedic surgical procedures, meaning it is intended for one-time use only and should not be reprocessed or reused.

  • What type of knee prosthesis is the Sulzer Orthopedics Allegretto Unicompartmental Knee?

    It is a femorotibial, non-constrained, cemented metal/polymer prosthesis designed specifically for unicompartmental knee replacement, as indicated in the device description and specifications.