Cleared Traditional

K890936 - ALTA HOLLOW TIBIAL RODS

K890936 is an FDA 510(k) clearance for ALTA HOLLOW TIBIAL RODS, 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 101-day FDA review.

K890936 · Howmedica Corp. · Orthopedic device
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Jun 1989
Decision
101d
Days
Class 2
Risk

K890936 is an FDA 510(k) clearance for the ALTA HOLLOW TIBIAL RODS. 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 June 5, 1989 after a review of 101 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K890936

510(k) Number K890936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1989
Decision Date June 05, 1989
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
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 K890936.
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
ALTA NON-REAMED TIBIAL ROD
K884500 · Howmedica Corp. · Jan 1989
INTERLOCKING INTRAMEDULLARY NAILS
K884610 · Depuy, Inc. · Dec 1988
ZINDRICK IM ROD INSTRUMENTS
K882443 · Buckman Co., Inc. · Jun 1988