MEDICAL COMPARTMENT KNEE PROSTHESIS— 510(k) K800640

Clearance details

Applicant

Dow Corning Wright

Product code

Code HSX

Device class

Class 2

Regulation

21 CFR 888.3520

Advisory panel

Orthopedic

Date received

1980-03-24

Decision date

1980-04-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, 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

• K932210 — ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT1994-09-07
• K932911 — ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT1994-06-30
• K934354 — LACEY ALL POLYETHYLENE TIBIAL COMPONENT1994-06-03
• K932222 — SLT FEMORAL HEAD1994-05-27
• K932858 — ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT1994-02-16

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 →