Cleared Traditional

K971993 - ODI COMPRESSION HIP SCREW SYSTEM

K971993 is an FDA 510(k) clearance for ODI COMPRESSION HIP SCREW SYSTEM, manufactured by Orthopaedic Designs, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K971993 · Orthopaedic Designs, Inc. · Orthopedic device
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Nov 1997
Decision
167d
Days
Class 2
Risk

K971993 is an FDA 510(k) clearance for the ODI COMPRESSION HIP SCREW SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Orthopaedic Designs, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on November 12, 1997 after a review of 167 days - an extended review 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: 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 Orthopaedic Designs, Inc. devices

FDA 510(k) Submission Details - K971993

510(k) Number K971993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1997
Decision Date November 12, 1997
Days to Decision 167 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
45d slower than avg
Panel avg: 122d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

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 348
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K971993.
SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM
K974537 · Synthes (Usa) · Feb 1998
THE CORIFIX DYNAMIC HIP SCREW SYSTEM
K973231 · Corin USA · Nov 1997
HOFFMANN II COMPACT PERIARTICULAR CLAMP
K973321 · Howmedica, Inc. · Nov 1997
VARI-ANGLE HIP SCREW (VHS) SYSTEM
K964880 · Walter Abendschein, M.D. · Oct 1997
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
K973017 · Synthes (Usa) · Oct 1997
DEPUY AE TK2 HIP SCREW SYSTEM
K972629 · Depuy, Inc. · Oct 1997