Cleared Traditional

K925460 - SYNTHES STERILE PINLESS EXTERNAL FIXATOR

K925460 is an FDA 510(k) clearance for SYNTHES STERILE PINLESS EXTERNAL FIXATOR, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 497-day FDA review.

K925460 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
497d
Days
Class 2
Risk

K925460 is an FDA 510(k) clearance for the SYNTHES STERILE PINLESS EXTERNAL FIXATOR. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 10, 1994 after a review of 497 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: 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 Orthopedic submissions.

View all Synthes (Usa) devices

FDA 510(k) Submission Details - K925460

510(k) Number K925460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1992
Decision Date March 10, 1994
Days to Decision 497 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
375d slower than avg
Panel avg: 122d · This submission: 497d
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 358
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K925460.
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K926417 · Alphatec Mfg., Inc. · Sep 1994
GAMMA LOCKING NAIL MODIFICATION
K940286 · Howmedica, Inc. · Mar 1994
GAMMA LOCKING NAIL-CROSS LOCKING SCREWS
K932174 · Howmedica Corp. · Mar 1994
CAP WASHER ASSEMBLY
K915599 · Howmedica Corp. · Oct 1993
ALTA CANCELLOUS BONE SCREW
K925127 · Howmedica Corp. · Mar 1993