Cleared Traditional

K885250 - ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL...

K885250 is the FDA 510(k) clearance for ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K885250 · Howmedica Corp. · Orthopedic device
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Feb 1989
Decision
53d
Days
Class 2
Risk

K885250 is an FDA 510(k) clearance for the ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on February 13, 1989 after a review of 53 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 K885250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1988
Decision Date February 13, 1989
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K885250.
INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM
K892228 · Intermedics Orthopedics · Oct 1989
DUPONT DISTAL HUMERAL NAIL
K890939 · Howmedica Corp. · May 1989
ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES
K890641 · Acufex Microsurgical, Inc. · Feb 1989
LUHR MICRO SYSTEM
K882454 · Howmedica Corp. · Aug 1988
ORTHOMET BONE PLATES
K875086 · Orthomet, Inc. · Jan 1988
HOFFMANN LEG LENGTHENING PLATE SYSTEM
K870388 · Howmedica Corp. · Apr 1987