Cleared Traditional

K934148 - TRUE/FLEX CLAVICLE RODS

K934148 is an FDA 510(k) clearance for TRUE/FLEX CLAVICLE RODS, manufactured by Applied Osteo Systems, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K934148 · Applied Osteo Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
181d
Days
Class 2
Risk

K934148 is an FDA 510(k) clearance for the TRUE/FLEX CLAVICLE RODS. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Applied Osteo Systems, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 181 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 Applied Osteo Systems, Inc. devices

FDA 510(k) Submission Details - K934148

510(k) Number K934148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1993
Decision Date February 22, 1994
Days to Decision 181 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
59d slower than avg
Panel avg: 122d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

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 499
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K934148.
ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL
K932593 · 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
MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM
K926213 · Osteo Technology, Inc. · Jun 1993
ALTA CFX ROD SYSTEM
K926232 · Howmedica Corp. · Jun 1993