Cleared Traditional

K972629 - DEPUY AE TK2 HIP SCREW SYSTEM

K972629 is an FDA 510(k) clearance for DEPUY AE TK2 HIP SCREW SYSTEM, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K972629 · Depuy, Inc. · Orthopedic device
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Oct 1997
Decision
87d
Days
Class 2
Risk

K972629 is an FDA 510(k) clearance for the DEPUY AE TK2 HIP SCREW SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 9, 1997 after a review of 87 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K972629

510(k) Number K972629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1997
Decision Date October 09, 1997
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 366
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K972629.
ODI COMPRESSION HIP SCREW SYSTEM
K971993 · Orthopaedic Designs, 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
TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM
K970748 · Smith & Nephew, Inc., Orthopaedic Div. · May 1997
ALPHATEC EXTERNAL FIXATION SYSTEM
K964400 · Alphatec Mfg., Inc. · Apr 1997
EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM
K970290 · Ebi, L.P. · Apr 1997