Cleared Traditional

K831143 - P.C.A. UNICOMPARTMENTAL KNEE PROSTHES

K831143 is an FDA 510(k) clearance for P.C.A. UNICOMPARTMENTAL KNEE PROSTHES, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K831143 · Howmedica Corp. · Orthopedic device
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Aug 1983
Decision
131d
Days
Class 2
Risk

K831143 is an FDA 510(k) clearance for the P.C.A. UNICOMPARTMENTAL KNEE PROSTHES. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983 after a review of 131 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K831143

510(k) Number K831143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1983
Decision Date August 16, 1983
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
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 82
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K831143.
MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
K860133 · Depuy, Inc. · Mar 1986
HOWMEDICA KINEMATIC II TIBIAL WEDGE
K842367 · Howmedica Corp. · Aug 1984
UNICONDYLAR FIBER METAL KNEE
K834298 · Zimmer, Inc. · Feb 1984
IOI METAL BACKED TIBIAL COMPONENT
K821341 · Intermedics Orthopedics · Jun 1982
BARD CONTOUR LINK S.K.I. KNEE SYS
K820002 · C.R. Bard, Inc. · May 1982
HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE
K820030 · Howmedica Corp. · Feb 1982