Cleared Traditional

K904844 - PRECISION HIP STEM WITH ADDITIONAL STEM...

K904844 is the FDA 510(k) clearance for PRECISION HIP STEM WITH ADDITIONAL STEM... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K904844 · Howmedica Corp. · Orthopedic device
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Dec 1990
Decision
41d
Days
Class 2
Risk

K904844 is an FDA 510(k) clearance for the PRECISION HIP STEM WITH ADDITIONAL STEM SIZES. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on December 5, 1990 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 K904844 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 25, 1990
Decision Date December 05, 1990
Days to Decision 41 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
81d faster than avg
Panel avg: 122d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 435
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K904844.
BIOPRO TRINITY ACETABULAR CUP
K904207 · Biopro, Inc. · Jan 1991
OSTEONICS(R) 6011 HIP STEM SERIES
K905158 · Osteonics Corp. · Jan 1991
OSTEONICS HIP REVISION WEDGES
K905406 · Osteonics Corp. · Jan 1991
PROXIMAL FEMUR REPLACEMENT STEM
K904919 · Depuy, Inc. · Dec 1990
PERFECTA TOTAL HIP SYSTEM
K903635 · Orthomet, Inc. · Nov 1990
OSTEONICS DRM ACETABULAR COMPONENT
K903636 · Osteonics Corp. · Oct 1990