Cleared Traditional

K911554 - AIM TIBIAL NAIL

K911554 is an FDA 510(k) clearance for AIM TIBIAL NAIL, manufactured by Ace Medical Co.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K911554 · Ace Medical Co. · Orthopedic device
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Jul 1991
Decision
90d
Days
Class 2
Risk

K911554 is an FDA 510(k) clearance for the AIM TIBIAL NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Ace Medical Co. (Los Angeles, US). The FDA issued a Cleared decision on July 8, 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 888.3020 - 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 Ace Medical Co. devices

FDA 510(k) Submission Details - K911554

510(k) Number K911554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1991
Decision Date July 08, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

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 379
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K911554.
INTRAMEDULARY FIXATION ROD
K920666 · Acu Med, Inc. · Aug 1992
INTERLOCKING TIBIAL NAILING SYSTEM
K915435 · Stryker Corp. · Mar 1992
INTERLOCKING FEMORAL NAILING SYSTEM
K912930 · Stryker Corp. · Jan 1992
ALTA(R) PFX IM ROD
K903526 · Howmedica Corp. · Mar 1991
HANSEN-STREET TYPE INTRAMEDULLARY NAIL
K903256 · Onyx Medical Corp. · Jul 1990
RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS
K893377 · Richards Medical Co., Inc. · Nov 1989