Cleared Traditional

K991854 - OSTEOPLAST, MODEL POP200

K991854 is an FDA 510(k) clearance for OSTEOPLAST, manufactured by Interpore Cross Intl.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 86-day FDA review.

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

FDA 510(k) Submission Details - K991854

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
Combination Product No
PCCP Authorized No
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.

MQV Device Classification - Class 2, Special Controls

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 454
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K991854.
PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
K000515 · Interpore Cross Intl. · Sep 2000
STIMULAN -CALCIUM SULFATE BONE VOID FILTER
K001724 · Biocomposites, Ltd. · Aug 2000
CALCIUM SULFATE PELLETS
K001559 · Howmedica Osteonics Corp. · Jun 2000
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE
K990131 · Interpore Cross Intl. · Mar 1999
STIMULAN- CALCIUM SULFATE BONE VOID FILLER
K982663 · Encore Orthopedics, Inc. · Feb 1999
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L
K980817 · Interpore Intl. · Sep 1998