Cleared Traditional

K935295 - ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION

K935295 is an FDA 510(k) clearance for ALTA FEMORAL INTRAMEDULLARY RODS/CFX RO..., 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 343-day FDA review.

K935295 · Howmedica Corp. · Orthopedic device
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Oct 1994
Decision
343d
Days
Class 2
Risk

K935295 is an FDA 510(k) clearance for the ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION. 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 October 11, 1994 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K935295

510(k) Number K935295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1993
Decision Date October 11, 1994
Days to Decision 343 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
221d slower than avg
Panel avg: 122d · This submission: 343d
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 530
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K935295.
FEMROD AND FEMROD RECON INSERT
K935383 · Applied Osteo Systems, Inc. · Mar 1995
TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION
K933995 · Applied Osteo Systems, Inc. · Jan 1995
TRUE/FLEX INTRAMEDULLARY ROD END-CAP
K944501 · Applied Osteo Systems, Inc. · Nov 1994
OSTEO INTERLOCKING-COMPRESSION NAIL
K933340 · Osteo AG · Jun 1994
INTRAMEDULLARY SYSTEMS
K930972 · Baumer Ortopedia , Ltd. · Mar 1994
ACE HUMERAL NAIL
K934643 · Ace Orthopedic Manufacturing Co. · Mar 1994
K935295 · ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION
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