Cleared Traditional

K050373 - UNICAP UNICOMPARTMENTAL KNEE RESURFACIN...

K050373 is an FDA 510(k) clearance for UNICAP UNICOMPARTMENTAL KNEE RESURFACIN..., manufactured by Arthrosurface, Inc.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K050373 · Arthrosurface, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
239d
Days
Class 2
Risk

K050373 is an FDA 510(k) clearance for the UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on October 11, 2005 after a review of 239 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 Arthrosurface, Inc. devices

FDA 510(k) Submission Details - K050373

510(k) Number K050373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2005
Decision Date October 11, 2005
Days to Decision 239 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
117d slower than avg
Panel avg: 122d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSX Device Classification - Class 2, Special Controls

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 103
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K050373.
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
K061779 · Smith & Nephew, Inc. · Aug 2006
COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE
K061011 · Smith & Nephew, Inc. · Jul 2006
MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
K060017 · Mako Surgical Corp. · Feb 2006
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
K043570 · Conformis, Inc. · Mar 2005
EIUS UNICOMPARTMENTAL KNEE SYSTEM
K033769 · Howmedica Osteonics Corp. · Feb 2004
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
K033363 · Zimmer, Inc. · Jan 2004