Cleared Traditional

K822943 - ELLISON VITALLIUM FIXATION STAPLE SYS

K822943 is the FDA 510(k) clearance for ELLISON VITALLIUM FIXATION STAPLE SYS by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K822943 · Howmedica Corp. · Orthopedic device
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Oct 1982
Decision
23d
Days
Class 2
Risk

K822943 is an FDA 510(k) clearance for the ELLISON VITALLIUM FIXATION STAPLE SYS. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1982 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 K822943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1982
Decision Date October 27, 1982
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 99
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K822943.
ORTHOMET ORTHOPEDIC STAPLES
K874914 · Orthomet, Inc. · Feb 1988
KIRSCHNER BONE FIXATION FASTENER SYSTEM
K854445 · Kirschner Medical Corp. · Nov 1985
BONE STAPLING FIXATION SYS
K840566 · 3M Company · Nov 1984
COLBALT ALLOY ORTHOPAEDIC WIRE
K811500 · Osteonics Corp. · Jun 1981
HOWMEDICA COMPRESSION STAPLE SYSTEM
K792204 · Howmedica Corp. · Dec 1979