Cleared Traditional

K971523 - DISTALLY FIXED HIP STEM

K971523 is an FDA 510(k) clearance for DISTALLY FIXED HIP STEM, manufactured by Sulzer Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K971523 · Sulzer Orthopedics, Inc. · Orthopedic device
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Oct 1997
Decision
156d
Days
Class 2
Risk

K971523 is an FDA 510(k) clearance for the DISTALLY FIXED HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Sulzer Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on October 1, 1997 after a review of 156 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Sulzer Orthopedics, Inc. devices

FDA 510(k) Submission Details - K971523

510(k) Number K971523 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 28, 1997
Decision Date October 01, 1997
Days to Decision 156 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
34d slower than avg
Panel avg: 122d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEH Device Classification - Class 2, Special Controls

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 134
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K971523.
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OSTEONICS ACETABULAR WEDGE SYSTEM
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