Cleared Special

K032117 - STRYKER TOTAL PERFORMANCE (TPS) SYSTEM

K032117 is an FDA 510(k) clearance for STRYKER TOTAL PERFORMANCE (TPS) SYSTEM, manufactured by Stryker Instruments. The device is a Class 2 Dental device with product code DZI cleared through the Special 510(k) pathway after a 30-day FDA review.

K032117 · Stryker Instruments · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
30d
Days
Class 2
Risk

K032117 is an FDA 510(k) clearance for the STRYKER TOTAL PERFORMANCE (TPS) 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 August 8, 2003 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K032117

510(k) Number K032117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2003
Decision Date August 08, 2003
Days to Decision 30 days
Submission Type Special
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
98d faster than avg
Panel avg: 128d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 49
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K032117.
PIEZOSURGERY DEVICE
K043408 · Piezosurgery S.R.L. · Jun 2005
MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55
K042434 · NOUVAG AG · Nov 2004
POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
K032607 · Linvatec Corp. · Nov 2003
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
K991696 · Stryker Instruments · Oct 1999
AMORPHOUS DIAMOND COATED DRILL
K990846 · Nobel Biocare Uas, Inc. · Jun 1999
STRYKER ORAL MAX SYSTEM
K954690 · Stryker Corp. · Aug 1996
K032117 · STRYKER TOTAL PERFORMANCE (TPS) SYSTEM
Download PDF FDA Summary Stryker Instruments