Cleared Traditional

K971900 - LATERAL FLARE INTERNAL COLLAR (LFIC)

K971900 is an FDA 510(k) clearance for LATERAL FLARE INTERNAL COLLAR (LFIC), manufactured by Pro-Lfic, LLC. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K971900 · Pro-Lfic, LLC · Orthopedic device
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Dec 1997
Decision
209d
Days
Class 2
Risk

K971900 is an FDA 510(k) clearance for the LATERAL FLARE INTERNAL COLLAR (LFIC). Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Pro-Lfic, LLC (Greenwich, US). The FDA issued a Cleared decision on December 18, 1997 after a review of 209 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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. Standard predicate reliance. 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 Pro-Lfic, LLC devices

FDA 510(k) Submission Details - K971900

510(k) Number K971900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1997
Decision Date December 18, 1997
Days to Decision 209 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 122d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LWJ Device Classification - Class 2, Special Controls

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 71
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K971900.
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PLUS-FIT ACETABULAR CUP
K973077 · Plus Orthopedics · Nov 1997
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K964178 · Encore Orthopedics, Inc. · May 1997