Cleared Traditional

K921383 - PRECISION STRATA TOTAL HIP STEM

K921383 is the FDA 510(k) clearance for PRECISION STRATA TOTAL HIP STEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K921383 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
94d
Days
Class 2
Risk

K921383 is an FDA 510(k) clearance for the PRECISION STRATA TOTAL HIP STEM. 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 June 25, 1992 after a review of 94 days - within the typical 510(k) review window.

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: 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

Submission Details

510(k) Number K921383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1992
Decision Date June 25, 1992
Days to Decision 94 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 122d · This submission: 94d
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 K921383.
MODULAR ACETABULAR CUP SYSTEM
K920430 · Smith & Nephew Richards, Inc. · Jul 1992
RX 90 ACETABULAR COMPONENT SYSTEM
K920639 · Biomet, Inc. · Jun 1992
FULL HEMISPHERE RING-LOC LINER
K920640 · Biomet, Inc. · Jun 1992
DEPUY TOTAL HIP BALLS - ION IMPLANTATION
K920286 · Depuy, Inc. · Apr 1992
OSTEONICS MICROSURFACED CDH HIP STEM
K920250 · Stryker Corp. · Apr 1992
BIOMET NTS FEMORAL COMPONENTS
K920161 · Biomet, Inc. · Apr 1992