# K011954: Sulzer Orthopedics Allegretto Unicompartmental Knee

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Sep 19, 2001 after 89 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stryker Howmedica Osteonics SCR Unicompartmental Knee: named in the summary without a submission number
- (no number) Sulzer Orthopedics Natural Knee Uni Knee: named in the summary without a submission number
- (no number) Styker Howmedica Osteonics PCA: named in the summary without a submission number
- (no number) Styker Howmedica Osteonics Minimally Invasive Uni Knees: named in the summary without a submission number
- (no number) Biomet Repicci II: named in the summary without a submission number
- (no number) Biomet Genus Uni Knees: named in the summary without a submission number
- (no number) Smith & Nephew Genesis Uni Knee: named in the summary without a submission number
- (no number) J & J Depuy PFC Uni Knee: named in the summary without a submission number
- (no number) Zimmer Miller/Galante Uni Knee: named in the summary without a submission number

## Most influential descendants
- K161592: Persona Partial Knee System (2016), 5 descendants of its own
- K212870: TLC Unicompartmental Knee System (2022), 2 descendants of its own
- K261609: Freedom Partial Knee System (2026), 0 descendants of its own
- K251771: Cambridge Partial Knee (2025), 0 descendants of its own
- K251834: Persona Partial Knee (2025), 0 descendants of its own

## Indications for use
The Allegretto Unicompartmental Knee consists of a distal femoral resurfacing component and a proximal tibial resurfacing component. It is intended to replace the medial or lateral component of the femorotibial knee joint, damaged as a result of non-inflammatory joint disease, or trauma. The device is a single-use implant intended for cemented use only. The Allegretto Unicompartmental Knee system is indicated for use in treatment of: 1. Unicompartmental noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis and arthritis secondary to a variety of diseases and anomalies. 2. Passively correctable valgus-varus deformity and moderate flexion contracture. 3. Those patients with failed previous surgery where pain, deformity or dysfunction persists.

Source page: https://510kreport.com/device/K011954
Methodology: https://510kreport.com/methodology