Cleared Traditional

WRIGHT PLASTER OF PARIS PELLETS (K963562) - FDA 510(k) Clearance

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

K963562 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
244d
Days
Class 2
Risk

K963562 is an FDA 510(k) clearance for the WRIGHT PLASTER OF PARIS PELLETS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on May 7, 1997 after a review of 244 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K963562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1996
Decision Date May 07, 1997
Days to Decision 244 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 122d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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 - MQV Filler, Bone Void, Calcium Compound

All 200
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K963562.
JAX GRANULES BONE VOID FILLER
K010557 · Smith & Nephew, Inc. · May 2001
SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)
K002362 · Synthes (Usa) · Nov 2000
CALCIUM SULFATE PELLETS
K001559 · Howmedica Osteonics Corp. · Jun 2000
WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)
K963587 · Wrightmedicaltechnologyinc · Mar 1997
WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION)
K960978 · Wrightmedicaltechnologyinc · Jun 1996