Cleared Traditional

K942032 - PLAMP, PLAMP PLATE, PLAMP WITH HOOK

K942032 is an FDA 510(k) clearance for PLAMP, manufactured by Hospital For Special Surgery. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 779-day FDA review.

K942032 · Hospital For Special Surgery · Orthopedic device
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Jun 1996
Decision
779d
Days
Class 2
Risk

K942032 is an FDA 510(k) clearance for the PLAMP, PLAMP PLATE, PLAMP WITH HOOK. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Hospital For Special Surgery (New York, US). The FDA issued a Cleared decision on June 13, 1996 after a review of 779 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Hospital For Special Surgery devices

FDA 510(k) Submission Details - K942032

510(k) Number K942032 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 26, 1994
Decision Date June 13, 1996
Days to Decision 779 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
657d slower than avg
Panel avg: 122d · This submission: 779d
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 K942032.
SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM
K962616 · Synthes (Usa) · Sep 1996
R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM
K961496 · Howmedica, Inc. · Jun 1996
PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM
K961497 · Howmedica, Inc. · Jun 1996
FOREFOOT RECONSTRUCTION SYSTEM
K961485 · Howmedica Corp. · Jun 1996
LACTOSORB TRAUMA PLATING SYSTEM
K960988 · Poly-Medics,Inc. · Apr 1996
ACE HUMERUS & RADIUS PLATES
K955472 · Ace Medical Co. · Apr 1996