Cleared Abbreviated

K030319 - ORTHOSPHERE CERAMIC SPHERICAL IMPLANT

K030319 is the FDA 510(k) clearance for ORTHOSPHERE CERAMIC SPHERICAL IMPLANT by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code KWD) cleared through the Abbreviated 510(k) pathway after a 300-day FDA review.

K030319 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
300d
Days
Class 2
Risk

K030319 is an FDA 510(k) clearance for the ORTHOSPHERE CERAMIC SPHERICAL IMPLANT. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on November 26, 2003 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3730 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K030319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2003
Decision Date November 26, 2003
Days to Decision 300 days
Submission Type Abbreviated
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
178d slower than avg
Panel avg: 122d · This submission: 300d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KWD Prosthesis, Toe, Hemi-, Phalangeal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3730
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 - KWD Prosthesis, Toe, Hemi-, Phalangeal

All 18
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K030319.
ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
K063058 · Arthrex, Inc. · Jan 2007
OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM
K060536 · Osteomed LP · Jun 2006
TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870
K041595 · Biopro, Inc. · Nov 2004
TOWNLEY GREAT TOE JOINT
K911378 · Biopro, Inc. · Nov 1991
SWANSON TITANIUM GREAT TOE IMPLANT
K864492 · Dow Corning Wright · Apr 1987
IMPLANT, H.P. CONDYLAR
K781870 · Dow Corning Corp. Healthcare Industries Materials · Feb 1979