Cleared Traditional

K103598 - PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES

K103598 is an FDA 510(k) clearance for PROPHECY PRE-OPERATIVE NAVIGATION ALIGN..., manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code MBH cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K103598 · Wrightmedicaltechnologyinc · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2011
Decision
313d
Days
Class 2
Risk

K103598 is an FDA 510(k) clearance for the PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on October 17, 2011 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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. Elevated predicate reliance profile. 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K103598

510(k) Number K103598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2010
Decision Date October 17, 2011
Days to Decision 313 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
191d slower than avg
Panel avg: 122d · This submission: 313d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBH Device Classification - Class 2, Special Controls

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 142
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