Cleared Traditional

K884500 - ALTA NON-REAMED TIBIAL ROD

K884500 is the FDA 510(k) clearance for ALTA NON-REAMED TIBIAL ROD by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K884500 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1989
Decision
84d
Days
Class 2
Risk

K884500 is an FDA 510(k) clearance for the ALTA NON-REAMED TIBIAL 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 January 18, 1989 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Howmedica Corp. devices

Submission Details

510(k) Number K884500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1988
Decision Date January 18, 1989
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K884500.
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
INTERLOCKING INTRAMEDULLARY NAILS
K884610 · Depuy, Inc. · Dec 1988
ZINDRICK IM ROD INSTRUMENTS
K882443 · Buckman Co., Inc. · Jun 1988
ZINDRICK IM ROD
K871539 · Buckman Co., Inc. · Aug 1987