Cleared Traditional

K971682 - J-FX CERCLAGE SYSTEM

K971682 is an FDA 510(k) clearance for J-FX CERCLAGE SYSTEM, manufactured by Johnson & Johnson Professionals, Inc.. The device is a Class 2 Orthopedic device with product code LRN cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K971682 · Johnson & Johnson Professionals, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
52d
Days
Class 2
Risk

K971682 is an FDA 510(k) clearance for the J-FX CERCLAGE SYSTEM. Classified as Wire, Surgical (product code LRN), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on June 27, 1997 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Johnson & Johnson Professionals, Inc. devices

FDA 510(k) Submission Details - K971682

510(k) Number K971682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1997
Decision Date June 27, 1997
Days to Decision 52 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 122d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRN Device Classification - Class 2, Special Controls

Product Code LRN Wire, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - LRN Wire, Surgical

Devices cleared under the same product code (LRN) and FDA review panel - the closest regulatory comparables to K971682.
NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
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K892651 · Danek Medical, Inc. · Jul 1989