Cleared Traditional

K820002 - BARD CONTOUR LINK S.K.I. KNEE SYS

K820002 is an FDA 510(k) clearance for BARD CONTOUR LINK S.K.I. KNEE SYS, manufactured by C.R. Bard, Inc.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K820002 · C.R. Bard, Inc. · Orthopedic device
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May 1982
Decision
143d
Days
Class 2
Risk

K820002 is an FDA 510(k) clearance for the BARD CONTOUR LINK S.K.I. KNEE SYS. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1982 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K820002

510(k) Number K820002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1982
Decision Date May 27, 1982
Days to Decision 143 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 122d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRY Device Classification - Class 2, Special Controls

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 75
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K820002.
UNICONDYLAR FIBER METAL KNEE
K834298 · Zimmer, Inc. · Feb 1984
P.C.A. UNICOMPARTMENTAL KNEE PROSTHES
K831143 · Howmedica Corp. · Aug 1983
IOI METAL BACKED TIBIAL COMPONENT
K821341 · Intermedics Orthopedics · Jun 1982
HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE
K820030 · Howmedica Corp. · Feb 1982
TOWNLEY UNICONDYLAR KNEE
K812012 · Depuy, Inc. · Sep 1981
P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH
K810060 · Howmedica Corp. · Apr 1981