Cleared Traditional

K000066 - SYNTHES (USA) LOCKING CONDYLAR PLATE (L...

K000066 is the FDA 510(k) clearance for SYNTHES (USA) LOCKING CONDYLAR PLATE (L... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K000066 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
65d
Days
Class 2
Risk

K000066 is an FDA 510(k) clearance for the SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 15, 2000 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Synthes (Usa) devices

Submission Details

510(k) Number K000066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2000
Decision Date March 15, 2000
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 903
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K000066.
LACTOSORB PANELS AND FASTENERS
K984390 · Biomet, Inc. · Aug 2000
SYNTHES (USA) ORIBITAL MESH PLATES
K001311 · Synthes (Usa) · Jun 2000
STRYKER TRAUMA PLATING SYSTEM
K000636 · Howmedica Osteonics Corp. · May 2000
LOCON-T DISTAL RADIAL PLATE
K994061 · Wrightmedicaltechnologyinc · Feb 2000
DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE
K993465 · Depuy, Inc. · Jan 2000
LACTOSORB TRAUMA PLATING SYSTEM
K992355 · Biomet, Inc. · Dec 1999