Cleared Traditional

K830307 - AUFRANC-TURNER ATS TOTAL HIP SYSTEM

K830307 is the FDA 510(k) clearance for AUFRANC-TURNER ATS TOTAL HIP SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code KWL) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K830307 · Howmedica Corp. · Orthopedic device
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Mar 1983
Decision
38d
Days
Class 2
Risk

K830307 is an FDA 510(k) clearance for the AUFRANC-TURNER ATS TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1983 after a review of 38 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 K830307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1983
Decision Date March 10, 1983
Days to Decision 38 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
84d faster than avg
Panel avg: 122d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, 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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 73
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K830307.
AUSTIN-MOORE MODULAR HIP PROSTHESIS
K845025 · Biomet, Inc. · Apr 1985
PENNSYLVANIA HOSPITAL HIP SYS
K841437 · Biomet, Inc. · Jun 1984
MODIFIED HPS HIP PROSTHESIS
K833599 · Depuy, Inc. · Mar 1984
METAL KNEE & HIP PROSTHESIS
K823051 · Zimmer, Inc. · Dec 1982
IOI 32 TM FEMORAL COMPONENT
K822321 · Intermedics Orthopedics · Aug 1982
KAMPNER FEMORAL COMPONENT
K822320 · Intermedics Orthopedics · Aug 1982