Balanced Knee System Uni— 510(k) K211471

Clearance details

Applicant

Ortho Development Corporation

Product code

Code HSX

Device class

Class 2

Regulation

21 CFR 888.3520

Advisory panel

Orthopedic

Date received

2021-05-11

Decision date

2021-12-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Draper, UT, US

• K261609 — Freedom Partial Knee System2026-08-04
• K260796 — Tahoe Unicondylar Knee System with TiNbN Overcoat2026-04-02
• K251771 — Cambridge Partial Knee2025-12-16
• K251834 — Persona Partial Knee2025-08-15
• K251618 — MOTO Partial Knee System Extension2025-07-24

• K233093 — Balanced Knee® System TriMax PS Plus Tibial Insert2023-10-25
• K211086 — The Progen Trochanteric Nail System2021-12-21
• K203023 — Pisces Spinal System2021-07-14
• K200281 — The Gecko Spinal System2020-03-31
• K182085 — Balanced Knee Revision System Trabecular Tibial Cone Augments2018-10-31

Injury

1,003

Other

1

Total

1,004

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →