Cleared Traditional

K874923 - PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE

K874923 is an FDA 510(k) clearance for PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL..., manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K874923 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1988
Decision
314d
Days
Class 2
Risk

K874923 is an FDA 510(k) clearance for the PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE. 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 October 12, 1988 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K874923

510(k) Number K874923 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 03, 1987
Decision Date October 12, 1988
Days to Decision 314 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
192d slower than avg
Panel avg: 122d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

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 885
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K874923.
AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT
K883122 · Depuy, Inc. · Dec 1988
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 SYS-ALL PLAS PATELLAR COMP
K881982 · Howmedica Corp. · Jul 1988
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES
K874635 · Osteonics Corp. · Mar 1988
PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG
K875201 · Orthomet, Inc. · Feb 1988