Cleared Traditional

K960988 - LACTOSORB TRAUMA PLATING SYSTEM

K960988 is an FDA 510(k) clearance for LACTOSORB TRAUMA PLATING SYSTEM, manufactured by Poly-Medics,Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K960988 · Poly-Medics,Inc. · Orthopedic device
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Apr 1996
Decision
34d
Days
Class 2
Risk

K960988 is an FDA 510(k) clearance for the LACTOSORB TRAUMA PLATING SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Poly-Medics,Inc. (Warsaw, US). The FDA issued a Cleared decision on April 10, 1996 after a review of 34 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 Poly-Medics,Inc. devices

FDA 510(k) Submission Details - K960988

510(k) Number K960988 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 07, 1996
Decision Date April 10, 1996
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
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 1088
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K960988.
PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM
K961497 · Howmedica, Inc. · Jun 1996
PLAMP, PLAMP PLATE, PLAMP WITH HOOK
K942032 · Hospital For Special Surgery · Jun 1996
FOREFOOT RECONSTRUCTION SYSTEM
K961485 · Howmedica Corp. · Jun 1996
ACE HUMERUS & RADIUS PLATES
K955472 · Ace Medical Co. · Apr 1996
SCHUHLI IMPLANT SYSTEM
K954963 · Synthes (Usa) · Mar 1996
VOLAR DISTAL RADIUS PLATE
K953644 · Synthes (Usa) · Mar 1996