Cleared Traditional

K771988 - VERTETRAC

K771988 is an FDA 510(k) clearance for VERTETRAC, manufactured by Ballert Orthopedic Corp.. The device is a Class 1 Neurology device with product code HST cleared through the Traditional 510(k) pathway after a 470-day FDA review.

K771988 · Ballert Orthopedic Corp. · Neurology device
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Feb 1979
Decision
470d
Days
Class 1
Risk

K771988 is an FDA 510(k) clearance for the VERTETRAC. Classified as Apparatus, Traction, Non-powered (product code HST), Class I - General Controls.

Submitted by Ballert Orthopedic Corp. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1979 after a review of 470 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.5850 - the FDA neurology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K771988

510(k) Number K771988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1977
Decision Date February 01, 1979
Days to Decision 470 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
321d slower than avg
Panel avg: 149d · This submission: 470d
Pathway characteristics
Predicate-based equivalence.

HST Device Classification - Class 1, General Controls

Product Code HST Apparatus, Traction, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HST Apparatus, Traction, Non-powered

All 37
Devices cleared under the same product code (HST) and FDA review panel - the closest regulatory comparables to K771988.
BAC JAC
K791919 · Haggin Industries, Inc. · Oct 1979
MEDI-TRAK PORTABLE TRACTION DEVICE
K791396 · Medicorp, Inc. · Aug 1979
OCTAGONAL ALUMINUM FRAMING SYSTEM
K790729 · Orthopedic Systems, Inc. · May 1979
BACK TRAC
K781647 · Tech Engineering, Inc. · Oct 1978
TRACTION UNITS
K780228 · Biomet, Inc. · Feb 1978
TRACTION WEIGHT BAGS
K780233 · Biomet, Inc. · Feb 1978
K771988 · VERTETRAC
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