Cleared Traditional

K990637 - SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD

K990637 is an FDA 510(k) clearance for SYNTHES LOCKING RECONSTRUCTION PLATE (L..., manufactured by Synthes (Usa). The device is a Class 2 Dental device with product code NEI cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K990637 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
238d
Days
Class 2
Risk

K990637 is an FDA 510(k) clearance for the SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD. Classified as Prosthesis, Condyle, Mandibular, Temporary (product code NEI), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on October 22, 1999 after a review of 238 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4770 - the FDA dental 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes (Usa) devices

FDA 510(k) Submission Details - K990637

510(k) Number K990637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1999
Decision Date October 22, 1999
Days to Decision 238 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 127d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEI Device Classification - Class 2, Special Controls

Product Code NEI Prosthesis, Condyle, Mandibular, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4770
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 Dental devices follow this clearance model.