Cleared Traditional

K870082 - BONE PLATE

K870082 is an FDA 510(k) clearance for BONE PLATE, manufactured by Terray Manufacturing, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K870082 · Terray Manufacturing, Inc. · Orthopedic device
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May 1987
Decision
118d
Days
Class 2
Risk

K870082 is an FDA 510(k) clearance for the BONE PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Terray Manufacturing, Inc. (Ontario K7s 1l8, CA). The FDA issued a Cleared decision on May 6, 1987 after a review of 118 days - within the typical 510(k) review window.

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: 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 Terray Manufacturing, Inc. devices

FDA 510(k) Submission Details - K870082

510(k) Number K870082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1987
Decision Date May 06, 1987
Days to Decision 118 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 122d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1297
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K870082.
LUHR MICRO SYSTEM
K882454 · Howmedica Corp. · Aug 1988
ORTHOMET BONE PLATES
K875086 · Orthomet, Inc. · Jan 1988
TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS
K873005 · Techmedica, Inc. · Sep 1987
HOFFMANN LEG LENGTHENING PLATE SYSTEM
K870388 · Howmedica Corp. · Apr 1987
KIRSCHNER (R) SMALL FRAGMENT FIXATION SYSTEM
K864924 · Kirschner Medical Corp. · Mar 1987
WARSAW ORTHOPEDIC BONE PLATE
K862254 · Warsaw Orthopedic, Inc. · Jul 1986