Cleared Traditional

K992837 - 3.5 MM 90 CANNULATED LIMITED CONTACT AN...

K992837 is the FDA 510(k) clearance for 3.5 MM 90 CANNULATED LIMITED CONTACT AN... by Synthes (Usa). It is a Class 2 Orthopedic device (product code KTW) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K992837 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 1999
Decision
63d
Days
Class 2
Risk

K992837 is an FDA 510(k) clearance for the 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATE.... Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on October 25, 1999 after a review of 63 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 K992837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1999
Decision Date October 25, 1999
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component
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 - KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component

All 22
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K992837.
MODULAR FOOT SYSTEM - 2.7 MM MODULE
K010321 · Synthes (Usa) · May 2001
STRYKER TRAUMA PELVIC SET
K001614 · Howmedica Osteonics Corp. · Aug 2000
SAMARCO SPIDER PLATES
K001271 · Biomet, Inc. · Jul 2000
CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE)
K982390 · Wrightmedicaltechnologyinc · Sep 1998
SYNTHES CANNULATED ANGLE BLADE PLATE
K954289 · Synthes (Usa) · Nov 1995
MALLEOLAR SCREW
K931686 · Onyx Medical Corp. · Apr 1994