Cleared Traditional

K973729 - POWERFLEX PEC IMPLANT

K973729 is an FDA 510(k) clearance for POWERFLEX PEC IMPLANT, manufactured by Hanson Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MIC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K973729 · Hanson Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
85d
Days
Class 2
Risk

K973729 is an FDA 510(k) clearance for the POWERFLEX PEC IMPLANT. Classified as Implant, Muscle, Pectoralis (product code MIC), Class II - Special Controls.

Submitted by Hanson Medical, Inc. (Kingston, US). The FDA issued a Cleared decision on December 24, 1997 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 874.3620 - the FDA general and plastic surgery device 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.

FDA 510(k) Submission Details - K973729

510(k) Number K973729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1997
Decision Date December 24, 1997
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MIC Device Classification - Class 2, Special Controls

Product Code MIC Implant, Muscle, Pectoralis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - MIC Implant, Muscle, Pectoralis

Devices cleared under the same product code (MIC) and FDA review panel - the closest regulatory comparables to K973729.
SILMAX PECTORAL IMPLANT
K002633 · Pillar Surgical, Inc. · Nov 2000
SEARE BIOMEDICAL PECTORALIS IMPLANT
K982762 · Seare Biomedical Corp. · Sep 1998
SEARE BIOMEDICAL SILICONE BLOCK
K983043 · Seare Biomedical Corp. · Sep 1998
PEC IMPLANT
K961072 · Rand Scientific Corp. · Apr 1996
SPECTRUM DISIGNS PECTORAL IMPLANT
K944163 · Spectrum Designs, Inc. · Nov 1994