Cleared Traditional

MICRO-SEAL ACETABULAR SYSTEM (K971718) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K971718 · Whiteside Biomechanics, Inc. · Orthopedic device
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Jul 1997
Decision
75d
Days
Class 2
Risk

K971718 is an FDA 510(k) clearance for the MICRO-SEAL ACETABULAR SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Whiteside Biomechanics, Inc. (Creve Coeur, US). The FDA issued a Cleared decision on July 23, 1997 after a review of 75 days - a notably fast clearance cycle.

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: 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 Whiteside Biomechanics, Inc. devices

Submission Details

510(k) Number K971718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1997
Decision Date July 23, 1997
Days to Decision 75 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 122d · This submission: 75d
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 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K971718.
INFINTY DISTAL FEMORAL COMPONENT
K973530 · Wrightmedicaltechnologyinc · Oct 1997
DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K970241 · Depuy, Inc. · Aug 1997
OSTEOLOCK ACETABULAR SHELL SYSTEM
K971854 · Howmedica Corp. · Jul 1997
INTERSEAL ACETABULAR SCREW HOLE PLUG
K971429 · Wrightmedicaltechnologyinc · Jul 1997
TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS
K964650 · Depuy, Inc. · Jun 1997
PEGGED ACETABULAR COMPONENT
K970501 · Biomet, Inc. · Apr 1997