TOTAL KNEE SYSTEM— 510(k) K780299

Clearance details

Applicant

Richard'S Medical Equip., Inc.

Product code

Code HRY

Device class

Class 2

Regulation

21 CFR 888.3530

Advisory panel

Orthopedic

Date received

1978-02-22

Decision date

1978-04-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

• K193549 — SIGMA High Performance (HP) Partial Knee System2020-04-16
• K190633 — NanoOrtho NanoKnee® System2019-12-20
• K152631 — MPO Total Knee Systems MR Labeling2016-03-23
• K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM2015-03-20
• K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)2014-03-28

• K830793 — PATIENT GUIDED ELBOW & SHOULDER EXERC1983-06-16
• K823837 — RMC TOTAL KNEE SYSTEM1983-03-29
• K823723 — SPECTRON PROXIMAL FEMORAL PROSTHESIS1983-03-09
• K823724 — SPECTRON NECK REPLACEMENT PROSTHESIS1983-03-09
• K823726 — SPECTRON CONVERSION ENDOPROSTHESIS CUP1983-03-09

Injury

1,551

Malfunction

2,753

Total

4,304

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 →