Cleared Traditional

K980944 - SYNTHES SCHUHLI IMPLANT SYSTEM

K980944 is an FDA 510(k) clearance for SYNTHES SCHUHLI IMPLANT SYSTEM, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K980944 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
46d
Days
Class 2
Risk

K980944 is an FDA 510(k) clearance for the SYNTHES SCHUHLI IMPLANT SYSTEM. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on April 27, 1998 after a review of 46 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

FDA 510(k) Submission Details - K980944

510(k) Number K980944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1998
Decision Date April 27, 1998
Days to Decision 46 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
76d faster than avg
Panel avg: 122d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTN Device Classification - Class 2, Special Controls

Product Code HTN Washer, Bolt Nut
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 - HTN Washer, Bolt Nut

All 86
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K980944.
DEPUY ORTHOTECH SPIKED WASHER
K983906 · DePuy Orthopaedics, Inc. · Dec 1998
SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M
K982354 · Special Devices, Inc. · Nov 1998
DEPUY ACE COMPOSITE LOCKING NUT
K983265 · Depuy Ace Medical Co. · Oct 1998
ACUMED SUTURE WASHER
K965028 · Acu Med, Inc. · Mar 1997
CANCELLOUS SCREW WASHER
K963420 · Orthopaedic Biosystems, Ltd. · Nov 1996
WASHER, BOLT, NUT, ORTHOPEDIC
K954682 · Linvatec Corp. · Feb 1996