Cleared Traditional

VARI-ANGLE HIP SCREW (VHS) SYSTEM (K964880) - FDA 510(k) Clearance

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

K964880 · Walter Abendschein, M.D. · Orthopedic device
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Oct 1997
Decision
315d
Days
Class 2
Risk

K964880 is an FDA 510(k) clearance for the VARI-ANGLE HIP SCREW (VHS) SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Walter Abendschein, M.D. (Chevy Chase, US). The FDA issued a Cleared decision on October 16, 1997 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Walter Abendschein, M.D. devices

Submission Details

510(k) Number K964880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1996
Decision Date October 16, 1997
Days to Decision 315 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
193d slower than avg
Panel avg: 122d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 175
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K964880.
SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM
K984498 · Synthes (Usa) · Feb 1999
BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR
K980370 · Biomet, Inc. · Apr 1998
SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM
K974537 · Synthes (Usa) · Feb 1998
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
K973017 · Synthes (Usa) · Oct 1997
DEPUY AE TK2 HIP SCREW SYSTEM
K972629 · Depuy, Inc. · Oct 1997
MEDOFF SLIDING PLATE (PROPOSED NAME)
K962251 · Wrightmedicaltechnologyinc · Jan 1997