Cleared Traditional

K903526 - ALTA(R) PFX IM ROD

K903526 is an FDA 510(k) clearance for ALTA PFX IM ROD, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K903526 · Howmedica Corp. · Orthopedic device
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Mar 1991
Decision
211d
Days
Class 2
Risk

K903526 is an FDA 510(k) clearance for the ALTA(R) PFX IM ROD. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on March 5, 1991 after a review of 211 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K903526

510(k) Number K903526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1990
Decision Date March 05, 1991
Days to Decision 211 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
89d slower than avg
Panel avg: 122d · This submission: 211d
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 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K903526.
INTERLOCKING TIBIAL NAILING SYSTEM
K915435 · Stryker Corp. · Mar 1992
INTERLOCKING FEMORAL NAILING SYSTEM
K912930 · Stryker Corp. · Jan 1992
AIM TIBIAL NAIL
K911554 · Ace Medical Co. · Jul 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
ALTA HOLLOW TIBIAL RODS
K890936 · Howmedica Corp. · Jun 1989