Cleared Traditional

K001559 - CALCIUM SULFATE PELLETS

K001559 is the FDA 510(k) clearance for CALCIUM SULFATE PELLETS by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K001559 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
32d
Days
Class 2
Risk

K001559 is an FDA 510(k) clearance for the CALCIUM SULFATE PELLETS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on June 20, 2000 after a review of 32 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K001559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2000
Decision Date June 20, 2000
Days to Decision 32 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
90d faster than avg
Panel avg: 122d · This submission: 32d
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 232
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K001559.
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
PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
K000515 · Interpore Cross Intl. · Sep 2000
OSTEOPLAST, MODEL POP200
K991854 · Interpore Cross Intl. · Aug 1999
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