510(k) · Cleared
ClearedStryker Total Performance (TPS) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · DZI Drill, Bone, Powered
Cleared on Aug 8, 2003 as substantially equivalent to K943540 (Stryker Corp., 1994) and 5 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1993. 238 later devices descend from it.
- Decided
- Aug 8, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K931783 (1993). 15 ancestors in all, the oldest K771218 (1978). 238 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 4 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 3 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 2 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 1 generation backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- This deviceK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- Descendant · cites it directly · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 3 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 4 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · 4 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
Showing 5 of 238 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 238 · See all- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · cites it directly226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 3 generations on202descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 4 generations on192descendants
- K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 4 generations on177descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −4 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −3 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −2 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −1 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| 0 (this device) | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| +1 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +2 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +3 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +4 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +4 | K090164 | Ceralas Multiwavelength 980/1470NM Diode Laser | Biolitec, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2010 | 10 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 9 | 0 |
| 2014 | 9 | 0 |
| 2015 | 11 | 0 |
| 2016 | 10 | 0 |
| 2017 | 7 | 0 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 12 | 0 |
| 2022 | 24 | 0 |
| 2023 | 13 | 0 |
| 2024 | 27 | 0 |
| 2025 | 29 | 0 |
| 2026 | 15 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZI device
- #1 K253776 Implantmed Plus II & Piezomed Plus II Modulescore 12.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K943540 | Surgical Cutting BursSummary page 1…Powered Simple Cranial Drill, Burrs, Trephines and their Accessories (per 21 CFR section 882.43 10) Equivalent to: Stryker TPS (DentabK943540, ENT-K943569, Neuro- 94354 l), TPS Hermes (991696), Stryker Navigation System (K012380)… | 1994 |
| * | K943569 | Stryker Total Performance SystemSummary page 1…Simple Cranial Drill, Burrs, Trephines and their Accessories (per 21 CFR section 882.43 10) Equivalent to: Stryker TPS (DentabK943540, ENT-K943569, Neuro- 94354 l), TPS Hermes (991696), Stryker Navigation System (K012380) and Dyon… | 1995 |
| * | K943541 | 75K Staight DrillSummary page 1…cut metal. Technological Technological characteristics are the same as previously cleared Comparison: for the Stryker TPS System (K943540, K943569, K943541, and K991696), Stryker Navigation System (KO12380) and Dyonics (K77 1218). Submitt… | 1995 |
| * | K991696 | Stryker Hermes-Ready Total Performance SystemSummary page 1…Technological characteristics are the same as previously cleared Comparison: for the Stryker TPS System (K943540, K943569, K943541, and K991696), Stryker Navigation System (KO12380) and Dyonics (K77 1218). Submitted by: Jean W. Sheppard… | 1999 |
| * | K012380 | Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual FluoroscopySummary page 1…ction 882.43 10) Equivalent to: Stryker TPS (DentabK943540, ENT-K943569, Neuro- 94354 l), TPS Hermes (991696), Stryker Navigation System (K012380) and Dyonics (K77 1218). Device Description: The device description of the Stryker System includes dri… | 2001 |
| * | K771218 | Intra-Articular ShaverSummary page 1…ker TPS (DentabK943540, ENT-K943569, Neuro- 94354 l), TPS Hermes (991696), Stryker Navigation System (K012380) and Dyonics (K77 1218). Device Description: The device description of the Stryker System includes drills, shavers, shields,… | 1978 |
What descends from it? (238)
See all 2384 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K040270 (Lumenis, Ltd., 2004) has gone furthest, with 226 descendants of its own.
- 4 other devices also cite its predicate K943540.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZI
300in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZI
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZI
39in 2025
MAUDE reports naming product code DZI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 53 |
| 2008 | 4 | 171 | 0 | 45 |
| 2009 | 5 | 220 | 1 | 22 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 4 | 191 | 0 | 25 |
| 2013 | 0 | — | 0 | 57 |
| 2014 | 1 | — | 0 | 50 |
| 2015 | 3 | 123 | 0 | 39 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 3 | 290 | 0 | 73 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 3 | 300 | 0 | 55 |
| 2021 | 0 | — | 0 | 84 |
| 2022 | 0 | — | 0 | 63 |
| 2023 | 1 | — | 0 | 63 |
| 2024 | 2 | — | 0 | 58 |
| 2025 | 1 | — | 0 | 39 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032117 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032117: Stryker Total Performance (TPS) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032117
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026