Cleared Traditional

K912930 - INTERLOCKING FEMORAL NAILING SYSTEM

K912930 is the FDA 510(k) clearance for INTERLOCKING FEMORAL NAILING SYSTEM by Stryker Corp.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K912930 · Stryker Corp. · Orthopedic device
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Jan 1992
Decision
192d
Days
Class 2
Risk

K912930 is an FDA 510(k) clearance for the INTERLOCKING FEMORAL NAILING SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on January 13, 1992 after a review of 192 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 Stryker Corp. devices

Submission Details

510(k) Number K912930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1991
Decision Date January 13, 1992
Days to Decision 192 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 122d · This submission: 192d
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 328
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K912930.
ALTA FEMORAL INTRAMEDULLARY ROD SYSTEM, ADD SIZES
K922266 · Howmedica Corp. · Sep 1992
INTRAMEDULARY FIXATION ROD
K920666 · Acu Med, Inc. · Aug 1992
INTERLOCKING TIBIAL NAILING SYSTEM
K915435 · Stryker Corp. · Mar 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