Cleared Traditional

K881982 - PCA MODULAR TOTAL KNEE SYS-ALL PLAS PAT...

K881982 is the FDA 510(k) clearance for PCA MODULAR TOTAL KNEE SYS-ALL PLAS PAT... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K881982 · Howmedica Corp. · Orthopedic device
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Jul 1988
Decision
68d
Days
Class 2
Risk

K881982 is an FDA 510(k) clearance for the PCA MODULAR TOTAL KNEE SYS-ALL PLAS PATELLAR COMP. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on July 19, 1988 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Howmedica Corp. devices

Submission Details

510(k) Number K881982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1988
Decision Date July 19, 1988
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 766
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K881982.
KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S
K883215 · Kirschner Medical Corp. · Nov 1988
JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS
K882234 · Johnson & Johnson Professionals, Inc. · Oct 1988
PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE
K874923 · Howmedica Corp. · Oct 1988
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES
K874635 · Osteonics Corp. · Mar 1988
PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG
K875201 · Orthomet, Inc. · Feb 1988
INTERMEDICS' NATURAL-KNEE(R) REVISION SYSTEM
K873602 · Intermedics Orthopedics · Jan 1988