Cleared Traditional

TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS (K873005) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K873005 · Techmedica, Inc. · Orthopedic device
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Sep 1987
Decision
28d
Days
Class 2
Risk

K873005 is an FDA 510(k) clearance for the TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Techmedica, Inc. (Camarillo, US). The FDA issued a Cleared decision on September 1, 1987 after a review of 28 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 Techmedica, Inc. devices

Submission Details

510(k) Number K873005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1987
Decision Date September 01, 1987
Days to Decision 28 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
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 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K873005.
DUPONT DISTAL HUMERAL NAIL
K890939 · Howmedica Corp. · May 1989
ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS
K885250 · Howmedica Corp. · Feb 1989
LUHR MICRO SYSTEM
K882454 · Howmedica Corp. · Aug 1988
HOFFMANN LEG LENGTHENING PLATE SYSTEM
K870388 · Howmedica Corp. · Apr 1987
SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION
K860600 · 3M Company · Mar 1986
DYNAMIC CONDYLAR SCREW OR D.C.S.
K840954 · Synthes (Usa) · May 1984