Cleared Traditional

K991696 - STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM

K991696 is an FDA 510(k) clearance for STRYKER HERMES-READY TOTAL PERFORMANCE ..., manufactured by Stryker Instruments. The device is a Class 2 Dental device with product code DZI cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K991696 · Stryker Instruments · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
160d
Days
Class 2
Risk

K991696 is an FDA 510(k) clearance for the STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on October 25, 1999 after a review of 160 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - 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 Stryker Instruments devices

FDA 510(k) Submission Details - K991696

510(k) Number K991696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1999
Decision Date October 25, 1999
Days to Decision 160 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
33d slower than avg
Panel avg: 127d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZI Device Classification - Class 2, Special Controls

Product Code DZI Drill, Bone, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
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.

Regulatory Peers - DZI Drill, Bone, Powered

All 44
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K991696.
MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55
K042434 · NOUVAG AG · Nov 2004
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K032607 · Linvatec Corp. · Nov 2003
STRYKER TOTAL PERFORMANCE (TPS) SYSTEM
K032117 · Stryker Instruments · Aug 2003
AMORPHOUS DIAMOND COATED DRILL
K990846 · Nobel Biocare Uas, Inc. · Jun 1999
STRYKER ORAL MAX SYSTEM
K954690 · Stryker Corp. · Aug 1996
MICROTEK MINI-MAX DRILL SYSTEM
K874535 · Microtek Medical, Inc. · Nov 1987