# K032117: Stryker Total Performance (TPS) System

- Pathway: 510(k) (Special)
- Applicant: Stryker Instruments
- Decided: Aug 8, 2003 after 30 days
- Product code: DZI (Drill, Bone, Powered)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K931783 (1993). 15 ancestors in all.
238 later devices descend from it; 4 cite it directly.
0 of 254 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943540: Surgical Cutting Burs, Stryker Corp. (1994) Summary page 1.
- K943569: Stryker Total Performance System, Stryker Corp. (1995) Summary page 1.
- K943541: 75K Staight Drill, Stryker Corp. (1995) Summary page 1.
- K991696: Stryker Hermes-Ready Total Performance System, Stryker Instruments (1999) Summary page 1.
- K012380: Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual Fluoroscopy, Stryker Leibinger (2001) Summary page 1.
- K771218: Intra-Articular Shaver, Dyonics, Inc. (1978) Summary page 1.

## Most influential descendants
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (2009), 177 descendants of its own

## Indications for use
The Stryker Total Performance (TPS) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, teeth and other bone related tissue in a variety of surgical procedures, including but not limited to Dental, ENT Neuro and Endoscopic. It is also usable in the placement of cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.

Source page: https://510kreport.com/device/K032117
Methodology: https://510kreport.com/methodology