Cleared Traditional

K905451 - SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE

K905451 is an FDA 510(k) clearance for SYSTEM TEN, manufactured by Advanced Osseous Technologies. The device is a Class 2 Orthopedic device with product code JDX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K905451 · Advanced Osseous Technologies · Orthopedic device
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Mar 1991
Decision
90d
Days
Class 2
Risk

K905451 is an FDA 510(k) clearance for the SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE. Classified as Instrument, Surgical, Sonic And Accessory/attachment (product code JDX), Class II - Special Controls.

Submitted by Advanced Osseous Technologies (Mountain View, US). The FDA issued a Cleared decision on March 5, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4580 - 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.

FDA 510(k) Submission Details - K905451

510(k) Number K905451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1990
Decision Date March 05, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDX Device Classification - Class 2, Special Controls

Product Code JDX Instrument, Surgical, Sonic And Accessory/attachment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.4580
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 - JDX Instrument, Surgical, Sonic And Accessory/attachment

All 20
Devices cleared under the same product code (JDX) and FDA review panel - the closest regulatory comparables to K905451.
OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION
K961725 · C.L. Mcintosh & Assoc., Inc. · Aug 1996
KOMET MEDICAL SURGICAL POWER ACCESORIES
K930109 · Brassler USA · Aug 1993
ITM SONIC SURGERY SYSTEM
K912931 · Buckman Co., Inc. · Oct 1991
SYSTEM TEN MODEL 100 SURGICAL SYSTEM
K900003 · Advanced Osseous Technologies · Mar 1990
MODIFIED PROFILE HIP ACETABULAR PROSTHESIS
K891408 · Depuy, Inc. · Jun 1989
ACE MOS SAW AND THE ACE MOS SPINE SAW
K862504 · Buckman Co., Inc. · Aug 1986
K905451 · SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE
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