Cleared Traditional

K971206 - MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING

K971206 is an FDA 510(k) clearance for MERIDIAN ST FEMORAL STEM AND VITALOCK S..., manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K971206

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.

LPH Device Classification - Class 2, Special Controls

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 536
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K971206.
ACTIVELOCK MODULAR FEMORAL HIP SYSTEM
K980020 · Metagen, LLC · Apr 1998
DEPUY TRI-LOCK HIP STEM
K974740 · Depuy, Inc. · Mar 1998
LSF HA COATED TRIAD TOTAL HIP SYSTEM
K974506 · Osteoimplant Technology, Inc. · Feb 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