Cleared Traditional

OSTEOPLAST, MODEL POP200 (K991854) - FDA 510(k) Clearance

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

K991854 · Interpore Cross Intl. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
86d
Days
Class 2
Risk

K991854 is an FDA 510(k) clearance for the OSTEOPLAST, MODEL POP200. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on August 26, 1999 after a review of 86 days - a notably fast clearance 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: 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 Interpore Cross Intl. devices

Submission Details

510(k) Number K991854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1999
Decision Date August 26, 1999
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 122d · This submission: 86d
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 201
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K991854.
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 PELLETS
K963562 · Wrightmedicaltechnologyinc · May 1997
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