SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM— 510(k) K012800

Clearance details

Applicant

Whiteside Biomechanics, Inc.

Product code

Code HRY

Device class

Class 2

Regulation

21 CFR 888.3530

Advisory panel

Orthopedic

Date received

2001-08-21

Decision date

2002-05-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Creve Coeur, MO, US

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• K033313 — QUATRO M FEMORAL COMPONENT2004-07-28
• K003618 — WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-10142001-05-23
• K993903 — WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-10132000-02-14
• K991678 — WHITESIDE BIOMECHANICS SPINAL SYSTEM1999-08-12
• K981238 — BIPOLAR FEMORAL HEAD1998-08-21

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 →