Cleared Traditional

K873458 - HOWMEDICA PCA COLLARED FEMORAL STEM

K873458 is the FDA 510(k) clearance for HOWMEDICA PCA COLLARED FEMORAL STEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDG) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K873458 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1987
Decision
26d
Days
Class 2
Risk

K873458 is an FDA 510(k) clearance for the HOWMEDICA PCA COLLARED FEMORAL STEM. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on September 23, 1987 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 K873458 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 28, 1987
Decision Date September 23, 1987
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

All 42
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K873458.
CTI STRAIGHT STEM
K873627 · Orthopedic Systems, Inc. · Dec 1987
WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO
K874740 · Dow Corning Wright · Dec 1987
THOMPSON HIP PROSTHESIS
K874617 · Orthopedic Systems, Inc. · Dec 1987
PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM
K873089 · Howmedica Corp. · Sep 1987
HOWMEDICA FEMORAL COMPONENT HIP SYS 6259
K851566 · Howmedica Corp. · Jul 1985
BIOPHASE IMPLANT MATERIAL
K792329 · Richard'S Medical Equip., Inc. · Jan 1980