Cleared Traditional

K971206 - MERIDIAN ST FEMORAL STEM AND VITALOCK S...

K971206 is the FDA 510(k) clearance for MERIDIAN ST FEMORAL STEM AND VITALOCK S... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K971206 · Howmedica Corp. · Orthopedic device
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Feb 1998
Decision
336d
Days
Class 2
Risk

K971206 is an FDA 510(k) clearance for the MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on February 11, 1998 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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. Elevated predicate reliance profile. 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 K971206 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 12, 1997
Decision Date February 11, 1998
Days to Decision 336 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
214d slower than avg
Panel avg: 122d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 436
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K971206.
REACH HIP COMPONENT
K982367 · Biomet, Inc. · Aug 1998
APR -T REVISION HIP STEM
K981211 · Sulzer Orthopedics, Inc. · May 1998
DEPUY TRI-LOCK HIP STEM
K974740 · Depuy, Inc. · Mar 1998
UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM
K974331 · Johnson & Johnson Professionals, Inc. · Feb 1998
FOUNDATION POROUS ACETABULAR SYSTEM
K973119 · Encore Orthopedics, Inc. · Jan 1998
FOUNDATION POROUS COATED HEMISPHERICAL SHELL
K974093 · Encore Orthopedics, Inc. · Jan 1998