Cleared Traditional

K932593 - ACCESS TO SYNTHES TI-6A1-7NB UNREAMED F...

K932593 is the FDA 510(k) clearance for ACCESS TO SYNTHES TI-6A1-7NB UNREAMED F... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K932593 · Synthes (Usa) · Orthopedic device
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Mar 1994
Decision
286d
Days
Class 2
Risk

K932593 is an FDA 510(k) clearance for the ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 10, 1994 after a review of 286 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Synthes (Usa) devices

Submission Details

510(k) Number K932593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1993
Decision Date March 10, 1994
Days to Decision 286 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
164d slower than avg
Panel avg: 122d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K932593.
TIBIA-TALUS-CALCANEUS NAIL
K950394 · Smith & Nephew Richards, Inc. · May 1995
ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION
K935295 · Howmedica Corp. · Oct 1994
SYNTHES UNREAMED HUMERAL NAIL (URHN)
K933518 · Synthes (Usa) · Mar 1994
THE MODULAR NAIL
K933027 · Smith & Nephew Richards, Inc. · Feb 1994
ACUMED RADIUS ROD
K933361 · Acu Med, Inc. · Feb 1994
SEIDEL HUMERAL LOCKING NAIL
K931256 · Howmedica Corp. · Jul 1993